Category Archives: Published Journal Articles

Breast Implants: A Research and Regulatory Summary

Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, and Judith Faucette, JD

More than 300,000 women and teenagers underwent breast implant augmentation surgeries in 2017. In addition, approximately 106,000 women underwent breast implant surgery for reconstruction after mastectomy.[1] The popularity of breast implants has risen dramatically in the last 20 years, and is now more than three times the 1997 rate of 101,176.[2]
The increase in breast implant surgery, however, does not necessarily reflect a similarly dramatic increase in the number of women with breast implants.  Many women who undergo surgery are replacing old implants that have broken or caused problems.  Some women report as many as ten or more surgeries as their implants are replaced over the years.  However, there are no available statistics on how many women undergo their first breast implant surgery every year.

As debate swirls over the risks of breast implants, physicians and patients are justifiably confused by the conflicting information available. In 2011, an international scandal revealed that tens of thousands of breast implants had been made with industrial silicone instead of medical grade silicone, the FDA reassured women that the high complication rate for breast implants was no higher than expected, and research revealed that breast implants increased the risk of a rare type of lymphoma.  This summary provides information about what is known and not known about the risks of breast implants.

The Role of the Food and Drug Administration (FDA) in Safety Research

Breast implants were first sold in the 1960s, but the FDA did not have the authority to regulate them until 1976.  Sales were relatively slow until the 1980s, but by 1990 almost one million women had breast implants, even though there were no published studies about their safety and the FDA had never approved them.  Finally, in 1991, the FDA required the manufacturers of silicone gel breast implants to submit safety studies.  Unfortunately, these studies were inadequate; for example, in the McGhan prospective study, two out of three patients were followed for less than three months, and there were only three breast cancer reconstruction patients.[3]Because of the lack of clinical data, silicone implants were not approved at that time.

Instead, the FDA issued a compassionate need exemption policy on October 23, 1992, which restricted silicone gel implants in the U.S. to women willing to participate in studies, including a large “Adjunct Study” for reconstruction patients and women with broken implants (called “revision” patients).  Approximately 1,000 women, including first-time augmentation, reconstruction, and implant replacement patients participated in each company’s “Core Study.”  It is important to note that the companies defined reconstruction patients to include many women who are not mastectomy patients.  Women were also be “reconstructed” to correct “deformities” such as very droopy breasts and “severe” asymmetry (both subjectively defined by the plastic surgeons).   Implant manufacturers could have collected and published extensive safety data from these studies.  However, they did not do so.

Major shortcomings were reported regarding the Adjunct and Core studies in terms of entry criteria, data collection, and patients’ informed consent.  Many patients reported that their physicians encouraged them to enroll in the Adjunct study as a way to qualify for silicone implants, explaining that they could drop out immediately after getting implants. That anecdotal claim is supported by the enormous loss in participants between enrollment and follow-up-Inamed data discussed at the FDA’s October 2003 Advisory Panel meeting indicated that only 27% of the reconstruction patients and 20% of the revision patients were followed for three years. Mentor’s Adjunct study data similarly had low follow up rates, with only 18% of revision patients and 19% of reconstruction patients were followed for three years.  As a result of this very low follow-up rate, these Adjunct “studies” did not provide meaningful safety data.

After that same Advisory Panel meeting, the FDA considered the scientific data and decided not to approve Inamed silicone breast implants in January 2004.  At the same time, the FDA issued a new guidance specifying the type of research manufacturers would need to present to obtain approval of any breast implants in the future.  A major focus of the guidance document is the need to determine why breast implants break, how long they last, and the health consequences of broken and leaking implants.

On April 11-13, 2005, the FDA held another Advisory Panel meeting to consider new research on silicone breast implants that was subsequently submitted by two companies, Inamed (currently called Allergan) and Mentor (now a subsidiary of Johnson & Johnson). Their studies only followed women for three years, which was not responsive to the FDA guidance asking that they determine how long implants last or the health consequences of leaking or broken implants.

In late 2005, the FDA Office of Criminal Investigation started an investigation of Mentor, interviewing former Mentor employee about the sale of defective implants by the company.  One employee admitted that executives ordered him to destroy documents related to a high rupture rate of Mentor implants and admitted that some implants were contaminated with fleas.[4]

Despite the short-term studies and the investigation of Mentor the FDA approved silicone gel breast implants by Inamed (now Allergan) and Mentor as “reasonably safe” for women who are 22 or older in November 2006.  This was the first time that FDA had approved silicone gel implants, and because of serious concerns about safety, the FDA required each of the two implant makers continue their 2-3 year studies for 10 years, and also start new studies of at least 40,000 women with breast implants for 10 years, in order to prove long-term safety.  The reason for the safety studies was to provide the kind of long-term data that were still lacking.  With few exceptions, the only published data regarding long-term safety were studies funded by implant companies, plastic surgeons, or silicone manufacturer Dow Corning.

After receiving requests for a public meeting by Congresswoman Rosa DeLauro (D-CT0 and the National Research Center for Women & Families, the FDA held an Advisory Committee meeting in August 2011 to discuss the longitudinal data from the Mentor and Inamed/Allergan studies.  The data were provided on the FDA web site in June 2011 and discussed at the August meeting.  In addition to invited presentations by the implant companies and FDA officials, several hours were set aside for public comments.  Several women testified that they were thrown out of the implant studies when they reported serious health problems from their breast implants or decided to have their implants removed.[5] This raised questions about the accuracy of the data presented.  Nevertheless, the FDA accepted the studies and maintained that silicone implants were safe and effective.[6]

The FDA’s approval of several models of breast implants as “reasonably safe” does not mean safe for everyone or in the long-term.  In fact, the FDA found that most implant patients have at least one serious complication within three years after getting silicone or saline implants.[7]

Types of Breast Implants

The 40-year history of silicone breast implants is a history of trying to reduce complications, especially common problems such as breast hardness and pain caused by capsular contracture.  Although breast implants were not studied in clinical trials for the first 25 years that they were used, clinical experience indicated that design modifications would seem to improve outcomes when they were first introduced, but later be found ineffective at fixing targeted problems and often causing new ones.  For example, since the mid-1960s, implant modifications have included adding a Dacron patch, removing the Dacron patch, changing the thick gel to a thinner gel, changing the thinner gel to a thicker gel, making the silicone shell textured, covering the shell with polyurethane foam, removing the foam when it was found to break down to a carcinogen, making the shell smooth, changing the shape of the implants, and reducing “silicone bleed.”  All of these changes were “studied” informally when patients underwent surgery, rather than in clinical trials. A Congressional report summarizing these changes referred to the patients as “guinea pigs.” [3]

The silicone gel breast implants that were reviewed by the FDA in 2005 and 2006 were essentially identical to those made in the early 1990s.  Inamed’s Senior Director of Regulatory and Clinical Affairs testified to the FDA in 2003 that “it is basically the same product it was 10 years ago…it is essentially the same product. [8]

In addition to changes in silicone gel breast implants, implant makers have tried to improve the product by using materials other than silicone gel.  Saline breast implants have a silicone envelope and are filled with salt water.  Saline breast implants have been available for decades, but it was not until May 2000 that the FDA approved saline implants for the first time.  Before approving these devices, the FDA required 3-year studies of local complications such as pain, infection, hardening, and the need for additional surgery.  They did not require studies of other health problems.  In addition to saline, three other kinds of implants were made available in the 1990’s, primarily outside the United States: Trilucent implants (with soybean oil filler), and Novagold and PIP hydrogel implants, which were filled with a plastic gel.  Although never approved as safe in the U.S., these implants were vigorously promoted by plastic surgeons and the media as a “natural” and safer alternative to silicone or saline implants.  Clinical trials, however, were apparently never conducted on humans with these implants, and all were removed from the market in 2000 due to safety concerns.[9],[10],[11],[12] Their removal from the market after being enthusiastically praised by doctors and patients serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use.

In 2012, FDA approved silicone gel implants made by a third company, Silimed, without a public meeting to review the much more cohesive implants made by Silimed.[13] Silimed’s implants have been described as “gummy bear” implants by one of the Principal Investigators in the study submitted to the FDA, referring to the rubbery consistency of gummy bear candies.  The goal of using such cohesive gel is to prevent leakage if the implant breaks.  However, there is reason to be concerned about the safety of this gel, because of the metals and chemicals that are used to make it. [14]

FDA approval is for specific models of silicone or saline breast implants by Inamed, Mentor, and Silimed, and are not for other implants made by the same companies or by other companies.

Implants made by several other companies, such as those made by the French company PIP, have been sold in other countries but have not been available in the U.S. for over a decade.   PIP silicone implants were taken off the market in Europe in 2011 because of a tendency to rupture sooner than other implants, and because testing indicated that the silicone was not intended for use in the human body but rather was intended for use in mattresses.[15],[16]

Public outrage and concern was so strong that several countries including France, the United Kingdom, Bolivia and Venezuela agreed to pay for implants to be removed, even for augmentation patients.[17]

Frequency of Local Complications

It is widely agreed that risks associated with implant surgery include infection, hematoma (blood or tissue fluid collecting around an implant), and the risks associated with anesthesia.

Pain and Capsular Contracture are also widely acknowledged complications: All implants are “foreign bodies,” and a woman’s body reacts to the foreign object by forming a capsule of scar tissue around the implants.  When this capsule becomes too hard or tight for the implant, it is called capsular contracture.  Capsular contracture can cause the breasts to become very hard or misshapen and can cause mild discomfort or severe, chronic pain.  Capsular contracture is common: research submitted in support of Inamed’s 2003 application to the FDA showed severe capsular contracture occurring in 16% of reconstruction patients and 8% of augmentation patients within 3 years.

Comparing Inamed data on saline breast implants and silicone gel breast implants shows many of the same types of complications; however, complication rates from silicone gel implants tend to be higher.[18],[19] For example, 46% of silicone gel reconstruction patients and 21% of saline reconstruction patients underwent at least one additional operation within three years, 25% of silicone patients and 8% of saline patients had implants removed, and 6% of silicone patients and 16% of saline patients had breast pain.[18],[19] Complication rates were lower but still substantial for augmentation patients.

A study of Danish women who had breast implants for an average of 19 years found that women with implants were almost three times as likely to report breast pain compared to breast reduction patients.  The question was not asked of women in a control group since it was assumed they did not experience breast pain.[20] In addition, two-thirds of the women with implants in the Danish study reported moderate or severe breast hardness.

There are other well-documented local complications that can result from breast implants.  For example, some women lose sensitivity in their nipples, and others become overly sensitive.  These problems can interfere with sexual intimacy.  The cosmetic outcome is also sometimes disappointing, with breasts looking or feeling unnatural or asymmetrical.

Rupture: All breast implants will eventually break.  When silicone gel breast implants break, there are often no symptoms, so accurate estimates of rupture rates depend on breast magnetic resonance imaging (MRIs).  Patient testimony before the FDA and clinical evidence indicate that some breast implants break during the first few weeks or months, while others last more than 15 years.  In a study conducted by researchers at the FDA and published in 2010, most women had at least one broken implant within 11 years, and the likelihood of rupture increased over time.[21]The women in the FDA study had not had their implants removed, did not know that their implants were broken, and were not seeking help because of implant concerns.  Despite the fact that these women were “satisfied customers” rather than women seeking medical care, MRIs indicated that silicone had migrated outside of the breast capsule for 21% of the women in the study. Most of the women were unaware that this had happened.  Inamed’s study of their silicone gel implants found that 1-6% break within three years.19 A Danish study of ruptured silicone gel implants reported that most lasted for ten years; however, by the time the women in that study had implants for 15 years or more, a substantial percentage of the implants broke every year.[22]

When the FDA approved saline implants in 2001 and silicone gel implants in 2006, it was based on studies of women who had Allergan and Mentor breast implants for 4 years or less, and rupture rates were quite low.  In 2011, the two companies provided data for women who had breast implants for 8 years (Mentor) and 10 years (Allergan).  Most of the women in the Mentor studies had dropped out before the 8-year follow-up, and problems with inaccurate complication rates make their findings questionable.  Many women also dropped out of the Allergan studies, but most reconstruction patients remained in their study.  After 10 years, the reported rupture rate was 27% for Allergan reconstruction patients.[23] This is not much higher than it was at 4 years, which is surprising.  Some patients report that they were dropped from the Mentor and Allergan studies when they told their plastic surgeons that they were having problems, raising questions about the accuracy of these findings.[24]

Leakage: Numerous studies have shown silicone leaks into the scar capsules surrounding breast implants, even for implants that are not ruptured.  More worrisome, researchers at Case Western Reserve and the Armed Forces Institute of Pathology reported finding silicone in the lymph nodes of women with breast implants, which can then migrate to other organs.[25],[26] Recent case studies have also confirmed that silicone can migrate to the lymph nodes.[27],[28] Silicone in the lymph nodes can only be removed by removing the lymph nodes.  Silicone in organs such as the lungs, liver, and brain cannot be removed.  The health risks associated with migrated silicone gel in these organs are unknown.  However, case reports have indicated fatalities and serious health risks when liquid silicone injected in the breasts migrated to the lungs or other organs.[29],[30] Although silicone implants are filled with gel rather than the liquid form of silicone, the implants sometimes leak a silicone liquid or thin gel.

A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant.[31] This has potentially serious implications for women with leaking breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants.

Mammography: Breast implants interfere with the detection of breast cancer because implants can obscure the mammography image of a tumor.  Implants therefore have the potential to delay the diagnosis of breast cancer.  Although special techniques are designed to minimize the interference of the implants, the most recent research indicates that 55% of breast tumors will still be obscured.[32] That is much higher than the 33% obscured in women without implants in the same study.  Mammograms also tend to be less accurate if the woman has capsular contracture.  In addition, a study by FDA scientists indicates that silicone or saline implants sometimes rupture when women undergo mammograms.[33] For that reason, women with implants may be reluctant to undergo mammograms because of fear of rupture.  The alternative, undergoing a regular breast coil MRI to check for cancer, is prohibitively expensive for many women at an average cost of $2,000 each time.

There is no research evidence that implants cause breast cancer, and research findings on whether there is a delay in diagnosis have been inconsistent.  A delay in diagnosis could have serious health implications and decrease women’s options for breast-conserving surgery.  Such delays have been reported by patients.[33]

Breastfeeding: According to the Institute of Medicine (IOM), women who have had any kind of breast surgery, including breast implant surgery, are up to three times more likely to have an inadequate milk supply for breastfeeding.[34] Concerns about the chemicals from the implants passing to infants through breastfeeding have also been raised.  There is insufficient research information available to make a determination on this risk.  However, a study presented at the American Chemical Society’s 2004 August meeting found exceptionally high concentrations of platinum, a known potential toxin, both in women with silicone breast implants and in the children they bore and breastfed.[35] The American Academy of Pediatrics always encourages breastfeeding unless there is clear evidence of risk, whether from implants or any other exposure.  However, they have not yet reviewed or formally commented on the aforementioned study.

Cancers, Lymphoma, and Lung Disease

In January 2011, the FDA announced that women with breast implants seem to be more likely to develop ALCL (anaplastic large cell lymphoma), a rare cancer of the immune system. The risk of developing ALCL is very low, but much higher in women with implants than it is in the general population.  ALCL is especially rare in the breast area, but for women with implants it has been found in fluid surrounding the implant and in the scar capsule, but not the breast tissue itself.  There is data to suggest that ALCL is more likely in implants with textured surfaces than with smooth surfaces.[36] The FDA is now requesting that physicians report cases of ALCL in women with breast implants to determine how great the risk is compared to women without implants and to talk with patients about the benefits and risks of textured-surface vs. smooth-surface implants.[64]

The new evidence regarding ALCL is an important reminder that it usually takes many years for cancer or other serious diseases to be diagnosed after an exposure.  For years, implant manufacturers have claimed that there are dozens of long-term studies proving that implants are safe.  Most of these “long-term” studies include large numbers of women who have had implants for a short period of time, ranging from one month to several years.  Although the women may have implants for an average of 5 or 8 or even 10 years, the number of women with implants for more than 10 years is quite small.  Epidemiologists estimate that at least 15-20 years of follow-up – and perhaps considerably more — would be necessary to conduct a well-designed study of cancer after exposure, whether to asbestos, tobacco, or breast implants.  For more than a decade, most published implant studies have been funded by Dow Corning, conducted by a core group of researchers at a research institute that receives substantial funding from Dow Corning, and have been used to defend the company from liability from their silicone implants and the silicone they sell to other companies.

There are very few published studies that have medically evaluated sufficient numbers of women with implants for a long enough period of time to evaluate whether or not implants cause cancer.  A study by scientists from the NCI found that women with breast implants were more likely to die from brain cancer, lung cancer, and other respiratory diseases, compared with other plastic surgery patients.[37] The NCI study compared augmentation patients to other plastic surgery patients, who were very similar in socio-economic status, health status, and health habits (including smoking).  Another strength of the study was that all the women had implants for at least 12 years.  Although this is not a long enough follow-up period for a conclusive cancer study, it is considerably longer than other implant studies.

A second NCI study found a 21% overall increased risk of cancer for women with implants, compared with women of the same age in the general population.[38] The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, and vulva cancer. Swedish and Danish studies also found a significantly increased risk of lung cancer among augmentation patients, but did not control for smoking.[39],[40]

Autoimmune and Connective Tissue Disease

The greatest controversy regarding the risks of breast implants concerns the question of whether they increase the risk of autoimmune disease and connective tissue disease. This issue has been raised again because ALCL is a cancer of the immune system, and is significantly associated with breast implants.  Studies from the 1990s tended to show no increase in risk of most autoimmune diseases, but more recent studies suggest that there is an increased risk of autoimmune symptoms and diseases.

A study conducted by FDA scientists found a statistically significant link between implants and fibromyalgia, as well as several connective tissue diseases.[41] The study focused on women who had silicone breast implants for at least six years, and found that women with leaking silicone implants were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia.  The risk of fibromyalgia remained even after controlling for patient’s age, implant age, and implant manufacturer.  Extracapsular leakage was evaluated in the study using an MRI.

A study by Aziz et al examined 95 women who had silicone gel-filled breast implants and rheumatologic symptoms.  These researchers found that the symptoms improved in 42 (97%) of the 43 women who had their breast implants removed and not replaced.[42] In contrast, rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed.

At the time that Mentor and Allergan were applying for approval for their silicone gel implants in 2005, they submitted data comparing the signs and symptoms of connective tissue diseases before and two years after patients got breast implants.  The companies reported that these signs and symptoms increased significantly, although they blamed the changes on age.  Nevertheless, according to the official FDA Summary for Inamed patients, dated March 2, 2005, there was an increase in “5 out of 8 of the [connective tissue disease signs and symptoms] categories including muscle pain, joint pain and fatigue for augmentation patients, even after adjusting for age.”[43] For Mentor implants, the FDA reported statistically significant increases in fatigue, exhaustion, joint swelling, frequent muscle cramps, joint pain, and fibromyalgia among augmentation patients, which the FDA concluded were not due to age.31

Scientists at the National Cancer Institute (NCI) found a statistically significant increase in reported connective tissue diseases among breast augmentation patients, but also found that many of the women made errors in their self-reported diagnoses.[44] For example, many women who reported having rheumatoid arthritis had osteoarthritis instead, according to their medical records.  The NCI study included women who had breast implants for at least seven years.  The findings suggest that there are increased symptoms among women with breast implants, but it is not clear if there is an increase in specific diagnoses.  As a result, the researchers concluded that the associations between breast implants and arthritis, scleroderma, Sjogren’s syndrome, and other connective tissue diseases need further study.

The Danish study mentioned above, focusing on Danish women who had breast implants for an average of 19 years, found that they were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), memory loss, and other cognitive symptoms than women of the same age in the general population.[20] Ten percent of the women with implants had already had their implants removed and not replaced, which might have reduced these symptoms.  Despite stating that women with implants were between two and three times more likely to report those symptoms, the researchers concluded that long-term exposure to breast implants “does not appear to be associated with” autoimmune “symptoms or diseases.”  The study was funded by silicone implant manufacturer Dow Corning.

Prior to these recent studies, most published research that focused on autoimmune or connective tissue diseases studied women who had implants for a relatively short time, ranging from a few months to a few years.  The minimum exposure to breast implants was usually one month.  These studies were the basis for a report on implants by the IOM, a report by Federal District Judge Sam Pointer’s National Science Panel, and a meta-analysis published in the New England Journal of Medicine regarding the lack of evidence that implants cause systemic disease.[34],[45],[46] All three of these reports are based on the same 17-20 epidemiological studies that were published prior to 1999.  Since many connective tissue and autoimmune diseases are relatively rare among young women and most take many years to develop and be diagnosed, these studies are not designed to answer questions about long-term safety.  Their major flaws are as follows:

  • The case-control studies relied on women accurately telling a stranger whether they had breast implants, and most included very few women who admitted to having breast implants. The accuracy of their responses was not verified.The studies include substantial numbers of women who had implants for just a few months or years, and therefore do not have the statistical power to determine whether or not breast implants increase the long-term risks of getting these diseases.The number of women in the studies who had breast implants for 10-15 years or more is too small to conclusively evaluate an increased risk of disease. Disease diagnoses were based on medical records or self-reports, not medical exams. Several studies had an even greater flaw-autoimmune disease was based on hospital records rather than medical diagnoses. Most women with autoimmune symptoms or diseases are not treated in hospitals.

Among the studies reviewed by the IOM, only one study, by Schusterman et al, included a diagnosis based on a medical exam, and all the women in that study had implants for less than two years-too short a time to meaningfully evaluate disease risk.  In addition, several European studies that purported to show no increased risk of autoimmune diseases actually indicated an increased risk of neurological or autoimmune disease that was similar for women who had breast augmentation or breast reduction. [47],[48] When comparing breast augmentation patients to breast reduction patients, the researchers reported that the augmentation patients were not significantly more at risk.  However, the articles clearly stated that both groups had a higher proportion of women with these diseases than expected.  Therefore, the interpretation of “no increased risk” was inappropriate.  Rather, both types of breast surgery patients were apparently at increased risk compared to the general population.

These findings raise concerns about autoimmune disease that need to be answered with long-term studies.  In addition, former FDA researchers have reported that silicone stimulates an immune response, and their cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.[49]

In summary, research on connective tissue and autoimmune diseases raises unanswered questions about long-term safety.  Results are not conclusive because of relatively short-term follow-up and limitations of the outcome measures.  Self-reports tend to show significant increases in health risks, whereas studies that rely on medical records and hospitalization are less likely to show significant increased risks.  In industry-funded studies, even when studies indicate an increase in symptoms among women with implants, the authors sometimes conclude that there is no evidence of increased health problems.  Overall, there is evidence of increased symptoms in several studies, and more research is needed to draw conclusions about the safety of implants in terms of systemic autoimmune disease.

Suicide and Depression

The same Swedish and Danish studies cited in the previous section, as well as a Finnish study, all found that women who have breast implants for augmentation were three times as likely to commit suicide as women in the general population of those countries.[39],[40],[50] The NCI study cited in the previous section also found a statistically significant increase in suicides for women with breast implants, but that study compared augmentation patients to other women plastic surgery patients of the same age, race, and education.[44] A recent study of mastectomy reconstruction patients in the U.S. also found a higher rate of suicide among implant patients compared to women who underwent mastectomies without reconstruction.[51]

The statistically significant increase in suicide in five studies has been subject of considerable debate.  Review articles funded by the American Society of Aesthetic Plastic Surgeons[52] and by Dow Corning[53] conclude that the increased risk of suicide is likely to predate implant surgery, and that women who choose breast implants are more likely to be depressed or have low self-esteem, as well as demographic traits that put them at higher risk of suicide. However, these assumptions are not supported by research data.  For example, the NCI study controlled for all the demographic variables associated with suicide (such as age and race) and compared augmentation patients with other plastic surgery patients, who are as likely to be insecure about their appearance as augmentation patients.[44] Similarly, the most important demographic predictors of suicide, which are age, race, and sex, were already controlled in the Scandinavian studies finding an increased risk of suicide.[39],[40].[50]

In support of the theory that poor mental health predates augmentation, one study pointed out that 8% of Danish augmentation patients had a psychiatric admission prior to augmentation surgery, compared to 6% of women undergoing other cosmetic procedures.  Like other plastic surgery patients in an era where plastic surgery is quite common and generally accepted, patients tend to be less satisfied with the body part that they are having surgically altered, but not less satisfied with their general appearance or themselves.[54] However, Danish women needed a psychiatric referral in order to qualify for free augmentation surgery, which could easily explain this small, non-significant difference.[55]

It is also important to note that a Danish study funded by Dow Corning found an increase in depression among women who had undergone breast augmentation.[20] In that study, the women with breast implants were five to seven times more likely to be taking antidepressants than comparison samples of women who underwent breast reduction surgery or women of the same age from the general population.  Among the augmentation patients, the women who had their implants removed and replaced at least once were more likely to be taking antidepressants than those who still had their original implants.  Although it is impossible to determine whether the women were also more depressed prior to breast augmentation, the relationship between multiple surgeries and use of anti-depressants suggests that complications from the implants may contribute to depression.

General Health, Quality of Life, and Self-Esteem

It is difficult to assess the impact of breast implants on health and mortality generally, because women who undergo breast augmentation tend to be healthier and more affluent than women in the general population. For example, NCI researchers found a lower mortality rate among augmentation patients compared to the general population of women their age, but a higher mortality rate among augmentation patients compared to other plastic surgery patients.  The authors concluded that plastic surgery patients are a more appropriate comparison sample, because they are more similar to augmentation patients in social class, health, health habits, and other key variables.[39]

A Canadian study of women with implants compared to the general population of women of the same age found that the augmentation patients were greater than four times more likely to be hospitalized, experienced more hospitalizations, and visited physicians and specialists more often.  In other words, augmentation patients cost the healthcare system significantly more than other patients of the same age and geographic location.[56]

A study of women who had breast implants after mastectomy came to the surprising conclusion that women with implants had a significantly better survival rate than other women of similar age, race, and diagnosis.[51] However, a critique of that study by NCI researchers pointed out that the better survival rates could have been the result of other advantages of the implant sample: including lower rates of obesity, higher social class, better prognosis, treatment at designated cancer centers, and use of adjuvant treatment.[57]

It is often assumed that breast implants improve the self-esteem and quality of life of women who undergo augmentation, as well as those having reconstruction after breast cancer.  However, the research does not support this assumption.  Studies of augmentation patients show no difference or improvement in self-esteem, compared to women who do not undergo augmentation.[54] Studies by NCI researchers and other national experts indicate that women who have undergone reconstruction report the same quality of life as women who did not have reconstruction after mastectomy.  In fact, implant patients are more likely to report that cancer harmed their sex life than women who underwent mastectomy without reconstruction.[58] Self-selection makes it difficult to interpret these data, but the Inamed/Allergan data presented at the October 2003 FDA meeting indicated a decrease in all quality of life measures two years after implants compared to before surgery.

Despite claims that breast implants would improve self-esteem and quality of life, most of the data presented in 2005 FDA summaries, based on the manufacturers’ data after two years of having implants, do not support those claims.  For Inamed/Allergan augmentation patients, 12 quality of life scores differed significantly in the pre-test and post-test, and nine of these 12 (75%) were worse in the post-test.  These include emotional health, physical health, general health, social like, vitality, and mental health.  The only improvements were in body esteem and feelings of physical attractiveness.[59]

Similar to the Inamed/Allergan findings, when there were statistically significant changes from pre-test to post-test for Mentor patients, almost all were worse in the post-test compared to the pre-test.  For augmentation patients, scores on physical health and mental health were significantly worse, scores on the Rosenberg self-esteem scale were better, and there was no change on the Tennessee self-concept scores or body esteem scale. [59]

Overall, these studies and their findings indicate that implant companies have yet to prove that implants objectively improve women’s quality of life, and 2-year studies suggest that most quality of life measures decline.[60]

The Hidden Costs

The initial surgery for breast implants is the first, but not the greatest expense for implant patients.  If silicone breast implants last approximately 7-10 years before breaking, replacement surgery will add greatly to the cost.  The implant itself may have a warranty for free replacement, but the surgical and anesthesia costs are not free, nor are the costs of the medical facility.  These expenses may not be affordable for all implant patients, especially since the initial breast augmentation is often available on an installment plan, while additional surgeries often need to be paid for upfront.

Cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are usually excluded from coverage.  In some states, major health insurance providers have refused to insure women with breast implants.  Some insurers have sold health insurance to women with implants, but charged them more, and some insurers have refused to cover certain kinds of illnesses for women with breast implants, or refused to cover any problems in the breast area.  For women who were diagnosed with diseases that were excluded, it would not matter if those diseases were unrelated to the implants.

What if a woman no longer wants breast implants?  Implants can be removed and not replaced, but the breast tissue stretches from the implant, and the breast is unlikely to be as attractive as it was before the implant surgery.[61] Women with leaking silicone implants often lose breast tissue as part of the removal surgery.  According to testimony presented at the October 2003 FDA meeting, this may result in surgery that is similar to a mastectomy.

Conclusions

In 1990, breast implants had been sold for more than 25 years but there were no published epidemiological studies or clinical trials.  There are now more than 100 studies of women with implants, most of them funded by Dow Corning, implant companies, or medical associations with a financial interest in the outcome.  These studies are persuasive in showing that breast augmentation does not dramatically increase the risk of diseases in the short-term.  A co-author of most of those studies, who served as a consultant to Inamed, argues that studies “with a mean follow-up of a decade and almost three decades of follow-up for the longest-term implant recipients” is “long enough.”[62],[63] However, there are numerous shortcomings in the studies he cites and co-authored, such as including many women whose implants were only a few months or a few years old at the time of the study, and therefore did not have the statistical power to draw meaningful conclusions about long-term safety.  The small number of women providing relevant long-term data is especially a problem when studying diseases such as cancer, scleroderma, and lupus which take years to develop and diagnose.  Careful scrutiny of the research indicates an increase in symptoms in many studies, but it is primarily in the studies where all the augmentation patients had implants for at least six years that increases in disease risks are statistically significant.  It is also notable that the independently funded studies tend to focus on women with implants for longer periods of time, and often show increased risks that are not apparent in the industry-funded studies.

All NCHR articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff. 

 

References


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[30] Restrepo CS, Artunduaga M, Carrillo JA, Rivera AL, Ojeda P, Martinez-Jimenez S, Manzano AC, Rossi SE. Silicone pulmonary embolism:  report of 10 cases and  review of the literature. J Comput Assist Tomogr. 2009 Mar-Apr; 33(2):233-7.

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[32] Miglioretti DL, Rutter CM, Geller BM, et al. Effects of breast augmentation on the accuracy of mammography and cancer characteristics. Journal of the American Medical Association. 2004; 291: 442-50.

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[39] Koot VCM, Peeters PHM, Granath F, et al. Total and cause specific mortality among Swedish women with cosmetic breast implants: prospective study. British Medical Journal. 2003; 326: 527-528.

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[44] Brinton LA, Buckley LM, Dvorkina O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004; 180: 619-27.

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[47] Friis S, Mellemkjaer L, McLaughlin JK, et al. Connective tissue disease and other rheumatic conditions following breast implants in Denmark. Annals of Plastic Surgery. 1997; 39: 1-8.

[48] Nyren O, Yin L, Josefsson S, et al. Risk of connective tissue disease and related disorders among women with breast implants: A nation-wide retrospective cohort study in Sweden. British Medical Journal. 1998; 316: 417-422.

[49] O’Hanlon TP. Restricted and shared patterns of TCR b-chain gene expression in silicone breast implant capsules and remote sites of tissue inflammation. Journal of Autoimmunity. 2000; 14: 283-293.

[50] Pukkala E, Kulmala I, Sirpa-Liis H, et al. Causes of death among Finnish women with cosmetic breast implants. Annals of Plastic Surgery. 2003; 51: 339-42.

[51] Le GM, O’Malley CD, Glaser SL et al. Breast implants following mastectomy in women with early-stage breast cancer: prevalence and impact on survival. Breast Cancer Research. 2005.

[52] Joiner TE. Does breast augmentation confer risk of or protection from suicide. Aesthetic Surgery Journal. 2003; 370-375.

[53] McLaughlin JK. Do Cosmetic breast implants cause suicide? Plastic and Reconstructive Surgery. 2003; 112: 1721-23.

[54] Sawrer DB, LaRosa D, Bartlett SP. Body image concerns of breast augmentation patients.Plastic and Reconstructive Surgery. 2003; 112: 83-90.

[55] Jacobsen PH, Hölmich LR, and McLaughlin JK. Mortality and suicide among Danish women with cosmetic implants. Archives of Internal Medicine. 2004; 164(22): 2450-55.

[56] Tweed A. Health care utilization among women who have undergone breast implant surgery.British Columbia Centre of Excellence for Women’s Health. Available: http://www.bccewh.bc.ca/publications-resources/documents/hcubreastimplants.pdf.

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[59] Food and Drug Administration. FDA Summary Panel Memo, P020056- Inamed Corporation Silicone-Filled Breast Implants.  Released March 2, 2005.  https://wayback.archive-it.org/7993/20161023020035 /http://www.fda.gov/ MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ ucm077303.htm.

[60] Zuckerman D. Reasonably safe? Breast implants and informed consent. Reproductive Health Matters. 2010; 18(35): 94-102.

[61] See photo #3 at  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM064348.

[62] McLaughlin JK. Long-term follow-up of women with cosmetic breast implants: How long is long enough? Plastic and Reconstructive Surgery. 2004; 114: 801-03.

[63] McLaughlin JK, Lipworth L, Murphy DK, Walker PS. The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence. Annals of Plastic Surgery. 2007 Nov; 59(5): 569-80.

[64] Food and Drug Administration. Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Released Summary of Safety and Effectiveness Data for Saline Breast Implants. Released March 2017. https://wayback.archive-it.org /7993/20170404175035/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ BreastImplants/ucm239995.htm.

 

 

Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide

Diana Zuckerman, PhD, National Center for Health Research, Caitlin Kennedy, PhD, Mishka Terplan, MD, MPH, Women’s Health Issues: August 2016

Breast augmentation is one of the most common cosmetic surgery in the United States, and many women are encouraged to undergo breast augmentation to improve their lives, self-esteem, or relationships. It is therefore surprising that studies in the United States and Scandinavian countries have shown that suicide rates are higher for women with breast implants.  These studies raise a key question: Do breast implants increase the risk of suicide or do pre-existing mental health problems increase the likelihood of undergoing breast implant surgery and also increase suicide risk?

This article is the first to take a comprehensive look at implants and suicide, by considering information from studies measuring self-esteem, self-concept, mental health, and quality of life among women before and after getting breast implants.

Our 2016 review of all published studies of breast implants and suicide identified 52 articles, but only 7 studies that provided original data on suicide among women with breast implants. All 7 studies found that women with breast implants had much higher suicide rates when compared to women with similar demographic traits – at least double the rate of suicides.  The greatest increase was among postmenopausal women with breast implants, who were 12 times more likely to commit suicide than postmenopausal women without breast implants.  Mastectomy patients with breast implants, many of whom were also post-menopausal, were 10 times as likely to commit suicide compared to mastectomy patients without breast implants. These differences were statistically significant.

Some plastic surgeons and researchers have hypothesized that patients seeking cosmetic surgery have lower self-esteem or tend to be more depressed than other women before they undergo surgery, and that would explain the higher suicide rate among breast implant recipients. However, our analysis of the 7 studies found that other plastic surgery patients were less likely to commit suicide than breast augmentation patients.  The study also found that females who underwent other types of plastic surgery procedures had lower suicide rates than the general female population, when accounting for age and race.  Studies comparing women’s self-esteem, self-identity, and quality of life before and after getting implants also show that these several of these qualities were higher than average prior to breast implant surgery but lower two years after implant surgery.

In other words, the relatively healthy and confident women who get breast implants tend to be less healthy and less confident afterwards. And, they are more likely to commit suicide.  That is true whether they got implants for augmentation or for reconstruction after a mastectomy.

In conclusion, the scientific evidence suggests that breast implants may have risks to mental health. Although suicide among women with implants was below 1% in each of the 7 studies, the rates ranging from 0.24% to 0.68% are significantly higher statistically and clinically than rates for comparable women without breast implants.  And, with millions of women with breast implants, the consistent evidence that women with breast implants are more likely to commit suicide is reason to be very concerned.  The research suggests that women who feel depressed or have low self-esteem should never be encouraged to get breast implants.

The research illustrates the importance of valid and reliable mental health screening to identify women considering breast augmentation who are vulnerable to depression or suicide.  Breast implant surgery should not be considered a strategy to fix low self-esteem or depression. Long-term studies on breast implant patients and depression, anxiety, and self-esteem are needed to give us a better understanding about the impact of implant surgery on women’s mental health and chances of suicide.

Download the article as a pdf here.
Read the original article here.

Next Steps for Breast Implant–Associated Anaplastic Large-Cell Lymphoma

Anna E. Mazzucco. “Next steps for breast implant–associated anaplastic large-cell lymphoma.” Journal of Clinical Oncology: June 16, 2014

To the Editor:

The excellent analysis by Miranda et al 1.based on extended follow-up of patients with breast implant-associated anaplastic large-cell lymphoma (ALCL) adds to the mounting evidence of the potential for aggressive clinical behavior of this disease.2,3For the first time, these researchers identified two patient subpopulations with distinct clinical outcomes: 75% of the patients with solid ALCL tumors had survived at 5 years postdiagnosis, compared with 100% of patients with effusion-type ALCL. In contrast, earlier studies suggested that breast implant–associated ALCL was likely to be clinically indolent and more similar to primary cutaneous, anaplastic lymphoma kinase (ALK) –negative ALCL, rather than the more aggressive systemic form of the disease.4,5

Although ALCL is rare, breast implants increase the risk by an estimated odds ratio of 18.2.6,7 Miranda et al1 found aggressive ALCL and potential mortalities associated with either saline or silicone-filled implants in both cosmetic and reconstruction patients, and point out that the lack of routine pathology examination of seroma or excised tissue could result in an underestimation of ALCL occurrence. Extrapolating from their findings, the lack of routine pathology is likely to delay the diagnosis when women with implants seek medical care from plastic surgeons or primary care physicians for swollen breasts that are assumed to be infected.

Timely diagnosis will depend on the millions of women with breast implants having access to heightened surveillance, knowledgeable physicians, and appropriate testing and medical care. All of the ALCL cases described in Miranda et al1 were ALK negative, which has a poor overall prognosis and is treated with cytotoxic chemotherapy.8 Others have proposed that all seromas associated with implants, especially those which are therapy resistant, should therefore be carefully monitored, and any patient presenting with recurrent seroma 6 months or more after implantation should undergo aspirate analysis without delay.9,10 The question is, how can such monitoring be ensured?

The track record for monitoring the health of patients with breast implants is not encouraging, however. For example, the US Food and Drug Administration recommends that all women with silicone gel breast implants undergo regular magnetic resonance imaging scans starting 3 years after implantation to check for implant rupture, but most insurance policies do not cover such screening; therefore, few women follow these guidelines. Moreover, many health insurance policies currently exclude any services related to complications from cosmetic surgery; this excludes the approximately 75% of women whose breast implants were originally for cosmetic purposes rather than reconstruction after mastectomy. Our research center’s recent review of health care policies under the Affordable Care Act found no evidence that the growing literature on breast implant–associated ALCL has influenced health insurance coverage for either cytology cultures of seroma or removal of breast implants and capsules that are causing ALCL.

Future studies are needed to elucidate what factors determine whether specific types of breast implants are more likely to increase the risk of ALCL, particularly solid tumors. The collaboration between the US Food and Drug Administration and the American Society of Plastic Surgeons to create a registry of implant recipients who develop ALCL should provide useful information. As new data become available, they should quickly be used to improve early diagnosis and treatment. That will require insurance coverage of medically necessary services for women with serious breast implant complications, including those with implants originally for cosmetic purposes.

Read the original article here.

 

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Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants

Diana Zuckerman, PhD, Nyedra Booker, PharmD, MPH, and Sonia Nagda, MD, MPH, Reproductive Health Matters: December 2012

In 2011, the European Union recalled the Poly Implant Prothèse (PIP) silicone breast implants. In the same year, the U.S. Food and Drug Administration (FDA) announced that breast implants were associated with an increased risk of developing a rare cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). These events raised questions about whether U.S. and European Union (EU) regulations are actually protecting patients from unsafe medical implants.

Initially breast implants in the U.S. were considered moderate-risk medical devices, but in 1988 breast implants were re-classified as high-risk. In the early 1990s, lawsuits, hearings, and Congressional investigations revealed that the breast implant manufacturers had covered up evidence that silicone gel breast implants could leak and the silicone could migrate into women’s lymph nodes. In 1991, new U.S. policy required that clinical trials prove that breast implants are safe and effective. In 1993, the European Union followed the lead of the U.S. in restricting access to silicone gel breast implants as part of broader new regulations in a Medical Device Directive released by the European Commission.

Both the U.S. and the EU classify breast implants as high-risk medical devices. The U.S. has required long-term clinical trials of breast implants, but hasn’t enforced those requirements. The EU does not require new clinical trials be done on breast implants if the breast implant manufacturers can justify relying on clinical data from previous studies on similar products.

As a result, clinical study data are limited and very few studies have looked at the long-term effects of breast implants.  Both the U.S. and the EU need to use more of their regulatory authority to ensure the long-term safety of breast implants.

Read the original article here.

Since the publication of the article, the EU has adopted stronger regulatory measures on medical devices that will be enforced beginning in 2020. You can read more about the new regulations here

Adolescents, Celebrity Worship, and Cosmetic Surgery

Anisha Abraham and Diana Zuckerman. “Adolescents, celebrity worship, and cosmetic surgery.” Journal of Adolescent Health 49.5 (2011): 453-454.

In 2010 researchers Dr. John Maltby and Dr. Liz Day published a study showing that media portrayal of celebrities influences adolescents decisions to undergo cosmetic surgery.  Maltby and Day studied 137 young adults between the ages of 18 and 23, using questionnaires to measure their attitudes toward celebrities whose body image they admired. The researchers followed up with the adolescents eight months later, and found that the adolescent women and men who showed intense “celebrity worship” were more likely to undergo elective invasive cosmetic procedures, even after controlling for other known predictors of cosmetic surgery, such as low self-esteem, greater preoccupation with body image, and previous cosmetic surgery. The study was published in the Journal of Adolescent Health in 2011, and did not include reconstructive surgeries such as correcting birth defects, or non-invasive procedures such as teeth whitening.  The most common procedures for these UK adolescents were breast augmentation, breast lift, liposuction, nose reshaping, laser skin resurfacing, Botox injections, and soft tissue fillers, which are also the most popular cosmetic procedures among adolescents in many Western countries. Although Botox injections and soft tissue fillers are not considered “surgery,” they are invasive procedures.

In a commentary by Dr. Anisha Abraham and Dr. Diana Zuckerman in the same journal, the two point out that the young adults in the study are not just mimicking the clothing and hairstyles of their favorite celebrities, but rather undergoing invasive procedures to feel better about how they look. This study has significant implications for the health and well-being of teenagers, as increasingly unrealistic expectations of what it means to be beautiful are perpetuated by TV shows, web sites, and advertisements featuring cosmetic surgery. The authors urge doctors to develop and use an effective screening process for adolescents who wish to undergo cosmetic procedures, which includes evaluating celebrity worship. Since self-concept improves and celebrity worship tends to decrease as adolescents mature, health professionals would do well to recommend that teenagers wait before undergoing cosmetic surgery. Guidelines for consent procedures that promote better screening and counseling for these young people could improve their decision process to get procedures that are invasive, expensive, and can result in serious medical complications. The authors conclude that the study indicates how crucial it is to encourage young people to be more self-confident and accepting of their bodies, rather than comparing themselves to “perfect” celebrities.

Read Anisha and Zuckerman’s full editorial here.

Read Malby and Day’s original article “Celebrity Worship and Incidence of Elective Cosmetic Surgery: Evidence of a Link Among Young Adults,” here.

Reasonably Safe? Breast Implants and Informed Consent

Diana Zuckerman, PhD, National Center for Health Research, Reproductive Health Matters: May 2010

Every year, more than 300,000 women in the United States and many more worldwide undergo breast implant surgery. This article, published in an international journal for medical professionals and health policy experts, considers the risks and benefits of implants, what we do and do not know about implants, and the information available to women who have implants or are considering the procedure. The article includes common risks such as capsular contracture and implant rupture or leakage, as well as the risks related to implant removal and replacement. It also considers the impact breast implants have on women’s lives in terms of how implants affect breastfeeding, how implants undermine the accuracy of mammography, the reports of implant breakage and leakage caused by the mammography pressure, and the lifetime cost of implants and related procedures. The information that the FDA and plastic surgery web sites give women on the risks of surgery, short-term and long-term risks of implants, costs, and benefits are compared with published information in medical journals and other sources.

Read the original article here.

Teens and Breast Augmentation

Diana Zuckerman and Anisha Abraham. Teenagers and Cosmetic Surgery: Focus on Breast Augmentation and Liposuction. Journal of Adolescent Health, October 2008.

Two of the most popular and controversial cosmetic procedures for adolescents are liposuction and breast implants.  This review article, describes the procedures and discusses the physiological and psychological reasons to delay these procedures in adolescents. The authors also describe concerns about body dysmorphic disorder and research findings that show changes in teenagers’ body image as they mature. Zuckerman and Abraham also highlight the lack of persuasive empirical research on the mental health benefits of plastic surgery for teenagers. Finally, the authors address the long-term financial and health implications of implanted medical devices that have a  limited lifespan. Adolescent medicine providers need to be involved in improving informed decision making for these procedures, aware of the absence of data on the health and mental health risks and benefits of these surgeries for teenagers, and understand the limitations on teenagers’ abilities to evaluate risks.

Read the full article here.

The Need to Improve Informed Consent for Breast Cancer Patients

Diana Zuckerman, Journal of the American Medical Women’s Association: February 2008

Abstract 

Many of the more than 182,000 women who will be newly diagnosed with breast cancer this year will not have access to all the information they need to make the surgical and treatment choices that are most appropriate for them. Research clearly shows that lumpectomy and other breast-conserving surgeries are just as safe as mastectomy for most women with early stage disease, and yet approximately half will undergo the more disfiguring procedures. Choices about breast implants and autologous tissue reconstruction are based, at best, on a few published studies that provide limited information about the long-term safety of these procedures. Many healthy women who have strong family histories of breast cancer consider prophylactic mastectomies, and their decisions are also based on very limited information, because there are few studies showing the effectiveness of that procedure. This paper delineates how limited information and biased recommendations can undermine breast cancer patients’ ability to make informed choices.

Introduction

Breast cancer is the most common malignancy in women in the United States; more than 182,000 women will be newly diagnosed this year.1 Unlike previous generations, most of these women will have several choices to make, including the type of surgery, whether to have radiation, the type of adjuvant therapy (chemotherapy or hormonal therapy), and the type of reconstruction, if any. However, many of these women will not have access to all the information they need to make the choices that are most appropriate for them.

There is considerable research evidence that where a woman lives, her income level and health insurance, the type of medical facility, when her doctor was trained, and the doctor’s enthusiasm for breast-conserving-surgery may have more impact on her surgical treatment than her specific diagnosis. For example, research has clearly shown that most women who are diagnosed with noninvasive or early-stage breast cancer can be very safely and effectively treated with breast-conserving surgery. And yet, so few women have this surgery that it raises questions about whether they are objectively informed about the advantages and disadvantages of their surgical options.2,3,4,5 In addition, the lack of research on some prevention and treatment options makes it impossible for many women to obtain the information they need to make fully informed choices. The purpose of this paper is to delineate how these and other choices made by many breast cancer patients may be based on limited information and sometimes biased recommendations, rather than the objective information needed for informed consent.

The historical context is essential to understanding why information may be inadequate. Many of today’s breast surgeons were trained at a time when there were few choices in breast cancer treatment, and tradition may still influence some doctors against breast-conserving surgery.6 Halsted developed the radical mastectomy in the 1890s; this procedure removed the breast, skin, nipple, areola, pectoral muscles, and all the axillary lymph nodes on the same side. Even more radical procedures were sometimes used, removing part of the breastbone and ribs to get the internal mammary nodes. In the 1940s, doctors in England developed the modified radical mastectomy, which removed the breast and axillary lymph nodes, but left the chest muscles intact. Although the reoccurrence rates seemed comparable to those for the Halsted, the modified radical mastectomy did not become more common than the Halsted procedure in most US hospitals until the mid-1970s.7

When researchers determined that many breast cancers grow slowly, treatment decisions became less urgent, and clinical trials were conducted to evaluate less radical procedures. In a study started in 1971, Fisher compared the survival of women who were randomized into three treatment groups: radical mastectomy, simple mastectomy (which removes only the breast and areola), and simple mastectomy with radiation.8 After 15 years, the survival rate was the same for all three groups. This study, published in 1985, was a turning point, resulting in surgical choices for more women diagnosed with breast cancer. Choices about radiation, chemotherapy, hormonal therapy, and reconstruction also influence surgical decisions. Now that women have so many choices to make, informed consent has become an important issue for breast cancer patients.

Informed consent relies on a patient receiving accurate information and freely making a decision based on that information. If objective information is not available on some aspects of breast cancer treatment because of lack of research, then the patient should be told that there is no research, or that existing research is inconclusive. If physicians describe their own experiences to patients, they should also explain the limitations of that information compared to data from long-term, objective empirical research.9

Breast-Conserving Surgery

In a landmark study comparing women with early-stage breast cancer who received breast-conserving surgery followed by radiation with those who had mastectomy, Fisher and his colleagues reported that eight years after surgery, approximately 91% of the women in both groups remained free of cancer.10 A consensus conference convened by the National Institutes of Health (NIH) in 1991 concluded that breast-conserving surgery with radiation was as effective as mastectomy for the treatment of early-stage breast cancer.11 The participants understood that breast-conserving surgery would not be the choice of every woman who was eligible, and that the expense, inconvenience, and fear of radiation would deter some women; nevertheless, the consensus was that lumpectomy and other breast-conserving surgery would be preferable for most patients.

The NIH holds consensus conferences to help experts come to a consensus about medical issues; the conferences also serve a public education function because the NIH publicizes the conclusions to physicians and patients across the country. The NIH consensus conference on breast cancer surgery was intended to help breast-conserving surgery gain wider acceptance by informing physicians and the public that these procedures are as safe as more radical surgery. In the decade since then, however, most of the women who have been eligible for lumpectomies have undergone mastectomies instead.

Women who are poor and who live in certain parts of the country are especially unlikely to have breast-conserving surgery. For example, in a 1995-1996 study of patients at a large, urban, university-affiliated Texas hospital serving primarily medically indigent patients, only 16% of those eligible received breast-conserving surgery.5 Although fear of breast cancer or radiation may make some women reluctant to choose breast-conserving surgery, one would expect that information clearly explaining that they would live just as long with lumpectomies as with mastectomies would reassure more than 16% of any group of women. Since breast-conserving surgery was believed to be safest for women with early-stage breast cancer, one would expect well-informed women with stage I breast cancer to be significantly more likely to undergo breast-conserving surgery than those with stage II breast cancer. Instead, the vast majority of women in this study underwent mastectomies regardless of stage, and the authors expressed concern that the surgeons’ opinions and recommendations were the likely reason for the high rate of mastectomy.

Several studies indicate that physicians’ knowledge or attitudes can deter women from choosing breast-conserving surgery. In a study of 157 hospitals in North Carolina, Kotwall et al found that patients were more likely to undergo breast-conserving surgery if their surgeons were trained after 1981 (by which time lumpectomies were becoming more widely accepted).3 Attitudes may be more important than knowledge; Tarbox et al reported that a substantial proportion of surgeons who knew that lumpectomy was as safe as mastectomy unknowingly influenced patients in favor of mastectomy with subtly biased presentations.4Similarly, Cady and Stone reported that the surgeon’s “interest and enthusiasm” for breast-conserving surgery increased the likelihood of patients choosing that treatment.12 Physician attitudes were also found to be influential in earlier studies of breast-conserving surgery.13,14

Lumpectomy with radiation is often more expensive than mastectomy,12 so financial incentives may also contribute to unnecessary mastectomies. Studies of low-income women indirectly support concerns that breast cancer patients are making surgical decisions that may not be based on informed choice. For example, the study of Texas indigent patients mentioned above5 found that mastectomy was more common among women with limited financial resources. A study of 20,000 breast cancer patients in North Carolina also reported lower lumpectomy rates among patients who did not have private insurance.3 Economic incentives may be influential even among Medicare patients, whose breast surgery is paid for by the federal government. A study of Virginia Medicare patients treated in 1992 and 1993 found that only 26% of the women who would be considered good candidates for breast-conserving surgery had such surgery, and this choice was most likely if the hospital had radiation oncology facilities on the grounds.15 Convenience was apparently not the only reason; patients who underwent surgery in hospitals without on-site radiation facilities were less likely to have breast-conserving surgery whether radiation facilities were nearby or far away. These findings suggest that economic incentives may influence surgeons’ discussion of treatment options or recommendations.

Researchers believe that physician knowledge and attitudes are a likely explanation for the dramatic regional differences they have documented in breast-conserving surgery: in 1986, breast-conserving surgery was more than twice as common in the Middle Atlantic states and New England than in the South Central states.16 There were also dramatic regional differences in a recent national study of ductal carcinoma in situ; 58% of women in New Mexico received mastectomies for this noninvasive breast cancer compared to only 29% in Connecticut.17 In a study of18 randomly selected hospitals in Massachusetts and 30 in Minnesota, 75% of Massachusetts women who were eligible for breast-conserving surgery made that choice, compared to only half in Minnesota.2 Convenience of radiation facilities could have been a factor, because Minnesota is more rural; however, informed consent seemed to play an important role as well. More mastectomy patients in Minnesota reported that their physicians did not discuss breast-conserving surgery, and even when their physicians did discuss the option, more Minnesota women reported choosing mastectomy because their physicians recommended it.2 Patient compliance with physicians’ recommendations is a related issue; Kotwall et al found that mastectomy patients were more likely to rely on the recommendations of their physicians, whereas patients who had breast-conserving surgery were more likely to obtain second opinions or to say they made the decision themselves.18

Differences in physician knowledge and attitudes could also contribute to widely varying breast-conserving surgery rates within states. For example, economic influences and hospital size or location did not fully explain breast-conserving surgery rates that ranged from 0 to 44% among Virginia hospitals caring for more than 12 Medicare breast cancer cases per year.15 Sometimes the difference in physician or clinic attitudes is very explicit. For example, the Mayo Clinic, which is the best-known medical facility in Minnesota, reported that its eligibility criteria for lumpectomy was different from other facilities, resulting in fewer women having breast-conserving surgery.19

Several states have laws aimed at improving informed consent by requiring the disclosure of options for the treatment of breast cancer.20 Research has shown the benefits and limitations of these efforts: after passage of the state laws, breast-conserving surgery rates increased by 9% in Michigan and 13% in Hawaii. The increases were not maintained over time, however, and the authors speculated that requiring physicians to provide objective information does not necessarily change their recommendations.

The statistical associations between mastectomy rates and financial incentives and physician characteristics do not prove that women are not receiving accurate information. However, five studies explicitly examined how physicians’ attitudes influenced their patients’ decisions and found that they either directly or indirectly influenced informed consent.2,4,12,13,14 A sixth study found that doctors trained in the era before lumpectomies were proven equally safe were less likely to perform them.3A seventh study found that women who had mastectomies were more likely to have relied on their physicians for advice, and women with breast-conserving surgery were more likely to have sought second opinions or relied on themselves for the decision.18 When considered together, these studies and those documenting different rates associated with geographic, insurance, socioeconomic, and other factors strongly suggest that physician attitudes and recommendations, most likely influenced by knowledge, training, and financial incentives, affected the information that patients received or the way they interpreted that information. In addition, the steady increase in lumpectomy rates during the last eight years, despite no new research regarding its safety, suggests substantial changes in the information that women are receiving, from their physicians or elsewhere.

Prophylactic Mastectomy

As women have become more aware of the risk factors for breast cancer, including family history and gene mutations, healthy women who are concerned about their risk of cancer are deciding whether to undergo prophylactic mastectomies. This raises informed consent issues in two ways: Are women receiving accurate and understandable information about their risk of breast cancer? And are they appropriately informed about the risks and benefits of prophylactic mastectomy?

The fact that women were willing to undergo prophylactic mastectomies even before research indicated that the surgery significantly reduces the risk of cancer indicates the level of fear associated with the disease. Statistics warning that one of every eight women will get breast cancer are often quoted in the media, but it is less widely understood that the lifetime risk is much higher than the risk for women under age 50 and exponentially higher than the risk that a woman of any age will get cancer in the next five years. The first step in informed consent for women considering prophylactic mastectomies should be to clarify the differences between lifetime risk and short-term risk, and to emphasize that estimates about the risks associated with genetic factors are very preliminary.

Informed consent for prophylactic mastectomy is limited by the paucity of research. One recent study indicated that prophylactic mastectomy reduced the rate of breast cancer in women with strong family histories of the disease.21 Those results were described on television and radio and published in major newspapers across the country, including The New York Times, The Washington Post, USA Today, and the Chicago Tribune. Two letters to the editor of the medical journal that published the study, however, pointed out that the risk of undergoing a mastectomy unnecessarily is also high. Hamm et al estimated that 13 women at moderate risk would lose their breasts unnecessarily for every prophylactic mastectomy that actually prevented one woman at moderate risk from getting breast cancer, and that 42 women at moderate risk of breast cancer or 25 women at high risk would have to have prophylactic mastectomies in order to prevent one death from breast cancer.22 Ernster estimated that 98% of women at moderate risk of breast cancer would not benefit from prophylactic mastectomy in terms of reduced mortality.23 According to a Lexis-Nexis search, the information from the letters was not widely published in the mass media and is therefore probably less available to women considering prophylactic mastectomy.

Reconstruction Options

If a woman has a mastectomy, she must also decide whether to undergo reconstruction and what kind of reconstruction, and her decision about mastectomy may be influenced by her views on the safety of reconstruction. Therefore, accurate, unbiased information regarding reconstruction is essential even before a woman decides to have a mastectomy.

The first breast implants were developed in the early 1960s for augmentation, not reconstruction. Halsted opposed reconstruction, and radical mastectomies left little tissue for it. With the increased popularity of modified radical mastectomies and simple mastectomies, however, plastic surgeons began to recommend the use of implants, urging that breast cancer patients had the “right” to replace breasts lost to cancer.24

At the time breast implants were first sold in the 1960s, the US Food and Drug Administration (FDA) did not regulate medical devices and therefore did not evaluate implant safety. When the FDA was given that authority in 1976, breast implants and many other devices were “grandfathered” and therefore allowed to stay on the market at least temporarily. Although there were warnings on the package inserts in the box containing breast implants, including the risk of breast hardening, rupture and gel leakage, infection, hematoma, swelling, pain, and necrosis,25 the package insert is enclosed in a sealed box that is not opened until surgery in order to keep the implant sterile. Implant patients are therefore dependent on their doctors for safety information. A pamphlet developed and widely distributed by the American Society of Plastic and Reconstructive Surgeons described implants as safe and did not mention that there were no empirical studies of long-term health effects.25

In 1991, the FDA required implant manufacturers to submit data proving that silicone gel breast implants were safe and effective, but the studies submitted were deemed too poorly designed to prove safety or effectiveness.26 In an almost unprecedented decision, however, the FDA allowed continued sale of silicone implants to mastectomy patients and women who wanted implant replacements, to meet a “public health need.” In 1992, the FDA approved a large-scale “clinical trial” to be conducted by one implant manufacturer, which was open to virtually any mastectomy patient; no data from that trial have yet been published or reviewed by the FDA.

Because of the lack of research on any kind of breast implants and concern about the almost one million women who already had them, Congress passed legislation in 1992 requiring the National Institutes of Health (NIH) to study the safety of breast implants. The NIH director refused to include mastectomy patients in this study of more than 13,000 implant patients, explaining to members of Congress that it would complicate the study design.26 There are, therefore, no epidemiological safety studies of mastectomy patients with implants funded by the federal government. Very few studies have examined even the short-term health outcome for mastectomy patients.27,28 Some studies of mastectomy patients have reported substantial complications, but their results are not widely disseminated and therefore are not available to most doctors or patients. For example, a five-year prospective study of silicone gel implants conducted by one implant manufacturer indicated that 24% of the mastectomy patients underwent at least one implant-related additional surgery within the first year, and 24% underwent surgery to remove at least one implant within the first two years (McGhan Medical Corporation, unpublished data, 1998). This unpublished study is available only on request from the Institute of Medicine (IOM) Library in Washington, DC.

Saline-filled breast implants have had a similar history. The FDA reviewed safety data provided by two manufacturers in March 2000 and approved the implants despite evidence that approximately three-fourths of the mastectomy patients studied had had serious complications in the first three years, including pain, implant rupture, additional surgery, hardness, or the need to have the implant removed.9,29 The FDA required the two implant manufacturers to add new warnings to their package inserts, but these warnings are, as before, provided to the surgeons in the sealed implant box rather than to the patients.

Women considering mastectomy and reconstruction should be informed of the lack of peer-reviewed research on implants for mastectomy patients and the high rupture, resurgery, and complication rates reported in unpublished studies. They should also be advised that no studies of the health risks of a saline implant with bacteria or mold breaking inside the body have been conducted. Patients will not have the information needed to make informed decisions if neither they nor their doctors have access to objective, peer-reviewed research conducted on mastectomy patients. Representatives of the American Society of Plastic and Reconstructive Surgeons provided testimony to the FDA that breast implants are very safe and that serious complications are rare.9 In contrast, a review of research conducted by FDA scientists reported that rupture was common, and a recent FDA study found that more than 79% of patients had at least one broken implant within 11 to 15 years.30,31

In the last decade, alternative breast reconstruction techniques have become increasingly available, using muscle and fat from the abdomen or back. Published studies on the safety and effectiveness of these types of breast reconstruction are limited; most are small case series of plastic surgeons’ own patients, which clearly raises questions about generalizability and objectivity. Even so, the articles raise concerns about skin or fat necrosis,32 especially among smokers;33 problems with inexperienced physicians,30 high complication rates,31,34 burns on reconstructed breasts due to impaired thermoregulatory capacity of transplanted tissue;35 and death.36

These surgeries are lengthy, complicated procedures, and the researchers warn that success rates vary greatly depending on the skill of the surgeon; it is therefore unlikely that the results from one practice are generalizable to most patients. In the absence of large multicenter clinical trials or empirical studies of a doctor’s own patients it is not possible for most doctors to provide good estimates of the risks associated with these procedures to their patients, thus greatly limiting informed consent.

Improving Informed Consent for Breast Cancer Patients

Informed consent for breast-conserving surgery, prophylactic mastectomy, and reconstructive surgery is limited partly because physicians themselves lack the information they need to appropriately inform their patients. In all these situations, informed consent should focus on what is not known about long-term risks in addition to what is known about failure rates and local complications. Physicians should provide as much objective information as possible, including long-term follow-up data from their own patients. We do not know if most doctors inform women of the lack of research, but there is clear evidence that at least one medical association is providing women with overly optimistic statements about the safety of implants. The ASPS website currently has an article stating that “Recent scientific studies have absolved silicone gel breast implants of causing health problems in women.” This statement is apparently based on studies showing no increased risks of autoimmune disease or cancer, but it ignores the IOM and FDA conclusions that implants can cause such serious health problems as pain, infection, and the need for multiple surgeries.

Signed consent forms provide liability protection and meet research requirements by giving detailed descriptions of the risks, known and unknown. In contrast, health professionals’ oral explanations of risks and benefits may be inconsistent with their own written materials. To improve informed consent for breast cancer patients, we need more information about the process of decision making. It is certainly likely that some women who are accurately and persuasively told that lumpectomies are as safe as mastectomies will choose mastectomies, and that some women who have mastectomies will choose reconstruction even if told that there are serious short-term risks and that the long-term risks are unknown. However, it is likely that better information will change the current pattern of high rates of unnecessary mastectomies followed by reconstruction.

In summary, more long-term safety data are needed on reconstruction options, better research is needed on the efficacy of prophylactic mastectomy, and many physicians need better access to the most accurate, unbiased information already available on breast cancer surgical outcomes. In addition, research is needed to better understand why the rate for breast-conserving surgery is so low, and what programs and policies would be most effective in ensuring that breast cancer patients receive objective information in ways that enable them to make the best possible medical and surgical choices. The bottom line is that many patients do not have the information they need to make informed choices, and patient advocates and policy makers need to support objective research and develop new strategies to ensure better informed consent for breast cancer patients.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

References

1 Cancer Facts and Figures 2000. Atlanta, Ga: American Cancer Society; 2000.

2 Guadagnoli E, Weeks JC, Shapiro CL, Gurwitz JH, Borbas C, Soumerai SB. Use of breast-conserving surgery for treatment of stage I and stage II breast cancer. J Clin Oncol. 1998; 16:101-106.

3 Kotwall CA, Covington DL, Rutledge R, Churchill MP, Meyer AA. Patient, hospital, and surgeon factors associated with breast conservation surgery: A statewide analysis in North Carolina. Ann Surg 1996;224:419-426.

4 Tarbox BB, Rockwood JK, Abernathy CM. Are modified radical mastectomies done for T1 breast cancers because of surgeon’s advice or patient’s choice? Am J Surg. 1992;164:417-420.

5 Dolan JT, Granchi TS. Low rate of breast conservation surgery in a large urban hospital serving the medically indigent. Am J Surg. 1998;176:520-524.

6 Treatment of early-stage Breast Cancer. NIH Consensus Statement Online. 1990;8:1-19. http://odp.od.nih.gov/consensus/cons/081/081_statement.htm.

7 Love SM. Dr. Susan Love’s Breast Book. 2nd ed. Reading, Mass: Addison-Wesley; 1995.

8 Fisher B, Redmond CB, Fisher E, et al. Ten-year results of randomized clinical trials comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med. 1985;312:674.

9 Testimony before the Food and Drug Administration Meeting on Saline Breast Implants, March 1, 2000. http://www.fda.gov.

10 Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin WM. Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med. 1995;1456-1461.

11 NIH Consensus Conference. NIH Consensus Conference: Treatment of early stage breast cancer. JAMA. 1991;265:391-395.

12 Cady B, Stone, MD. Selection of breast-preservation therapy for primary invasive breast carcinoma. Surg Clin North Am. 1990;70:1047-1049.

13 Ward S, Heidrick S, Wolberg W. Factors women take into account when deciding upon type of surgery for breast cancer. Cancer Nurs. 1989;12:344-351.

14 Liberati A, Apolone G, Nicolucci A, et al. The role of attitudes, beliefs, and personal characteristics of Italian physicians in the surgical treatment of early breast cancer. Am J Public Health. 1990;81:38.

15 Elward KS, Penberthy LT, Bear H, Swartz DM , Boudreau RM, Cook SS. Variation in the use of breast-conserving therapy for Medicare beneficiaries in Virginia: Clinical, geographic, and hospital characteristics. Clin Perform Qual Health Care. 1998;6:63-69.

16 Nattinger AB, Gottlieb MS, Veum J, et al. Geographic variation in the use of breast-conserving treatment for breast cancer. N Engl J Med. 1992;3326:1102-1107.

17 Ernster VL, Barclay J, Kerlikowske K, et al. Incidence of and treatment for ductal carcinoma in situ of the breast. JAMA. 1996;275:913-918.

18 Kotwall CA, Maxwell JG, Covington DL, Churhill P, Smith SE, Covan EK. Clinicopathologic factors and patient perceptions associated with surgical breast-conserving treatment. Ann Surg Oncol. 1996;3:169-175.

19 Grant CS. Changes in the treatment of early breast cancer at the Mayo Clinic: 1988-1992.Eur J Surg. 1996;162:93-96.

20 Nattinger AB, Hoffman RG, Shapiro R, Gottlieb MS, Goodwin JS. The effect of legislative requirements on the use of breast-conserving surgery. N Engl J Med. 1996;335:1035-1040.

21 Hartmann LC, Schaid DJ, Woods JE, et al. Efficacy of bilateral prophylactic mastectomy in women with a family history of breast cancer. N Engl J Med. 1999;340:77-84.

22 Hamm RM, Lawler F, Scheid, D. Prophylactic mastectomy in women with a family history of breast cancer. N Engl J Med. 1999;340:1837-38. Letter.

23 Ernster VL. . Prophylactic mastectomy in women with a family history of breast cancer. N Engl J Med. 1999;340:1838. Letter.

24 Jacobson N. The socially constructed breast: Breast implants and the medical construction of need. Am J Public Health. 1998;88:1254-1261.

25 Is the FDA Protecting Patients From the Dangers of Silicone Breast Implants? Hearing before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, U.S. House of Representatives. Washington, DC: US Government Printing Office; 1991: 179-185, 278-370.

26 The FDA’s Regulation of Silicone Breast Implants: Staff Report for the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, U.S. House of Representatives. Washington, DC: US Government Printing Office; 1993.

27 Safety of Silicone Breast Implants. Washington, DC: Institute of Medicine; 1999.

28 Zuckerman D. Summary of Studies of Saline Implants and Connective Tissue Diseases. http://www.cpr4womenandfamilies.org/implant.html.

29 Local Complications of Saline Breast Implants.http://www.cpr4womenandfamilies.org/implant.html.

30 Brown SL, Silverman BG, Berg W. Rupture of silicone-gel breast implants: Causes, sequelae, and diagnosis. Lancet. 1997; 350:1531-1537.

31 Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants in a population of women in Birmingham, Alabama. Am J Roentgenol 2000; 175: 1057-1064.

32 Baldwin BJ, Schusterman MA, Miller MJ, et al. Bilateral breast reconstruction: Conventional versus free TRAM. Plast Reconstr Surg. 1994;93:1410-1416.

33 Schusterman MA, Kroll SS, Miller MJ, et al. The free transverse rectus abdominis musculocutaneous flap for breast reconstruction: One center’s experience with 211 consecutive cases. Ann Plast Surg. 1994;32:234-241.

34 Delay E, Gounot N, Bouillot A, et al. Autologous latissimus breast reconstruction: A 3-year clinical experience with 100 patients. Plast Reconstr Surg. 1998;102:1461-1478.

35 Nahabedian MY, McGibbon BM. Thermal injuries in autogenous tissue breast reconstruction. Br J Plast Surg. 1998; 51:599-602.

36 Hamdi M, Weiler-Mithoff EM, Webster MH. Deep inferior epigastric perforator flap in breast reconstruction: Experience with the first 50 flaps. Plast Reconstr Surg. 1999;103:86-95.

Reconstructive Breast Implantation After Mastectomy

Diana Zuckerman, Commentary published in the Archives of Surgery: July 2006.

Henriksen et al provided useful data on the short-term complications of breast reconstruction with implants. Although the invited critique described the complication rate as “alarmingly high and arguably unacceptable,” the complication rate is even higher in other studies with superior study designs.

For example, a study conducted by implant manufacturer Inamed found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants – more than twice as high as the 21% reported by Henriksen et al. One explanation is that the women in the Henriksen study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Henriksen et al reported that 31% developed at least one serious complication and 16% developed at least 2 serious complications. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture, 6% experienced necrosis, 6% had breast pain, and 6% had scarring, in addition to infections and other complications.

Henriksen et al concluded that “reconstruction failure (loss of implant) is rare.” However, in addition to the short follow-up, Henriksen et al did not use Magnetic Resonance Imaging (MRIs) to detect rupture, thus under counting the number of ruptures according to the FDA. A study using MRIs found that 20% of reconstruction patients had ruptured implants by the third year; very few ruptures were detected without MRIs. Food and Drug Administration scientists concluded that the risk of rupture would likely increase exponentially every year.

Henriksen et al’s lack of MRI use also helps explain the lower rate of additional surgery. If a woman underwent an MRI and learned that her implant was ruptured, she would probably have surgery to remove it.

In his critique, Singh states that “the immunologic and systemic complications ascribed to implants (silicone or saline) have been debunked by the Institute of Medicine’s 1999 definitive report.” However, most research on diseases among implant patients was published after 1999. The IOM report included only 17 studies of autoimmune diseases among implants, almost all of which studied small numbers of women for short periods of time. Many of the studies reported higher levels of disease or symptoms among women with breast implants, which would have reached statistical significance if maintained in larger studies conducted for a longer period of time. For example, the study by Schusterman et al, included only 250 women with implants, all of whom had implants for 2 years.

In 2001, Food and Drug Administration scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared to women with silicone implants without extracapsular leakage. The National Cancer Institute (NCI) found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared to other plastic surgery patients. National Cancer Institute findings regarding autoimmune diseases were not definitive. National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases.

The unanswered questions about diseases and the high complication rate for breast cancer patients raise important safety issues about breast implants. It is difficult for patients to receive informed consent when definitive long-term data are not yet available.

References:

1 Henriksen TF, Fryzek JP, Holmich LR et al Reconstructive breast implantation after mastectomy for breast cancer: clinical outcomes in a nationwide prospective cohort study. Arch Surg. 2005; 140: 1152-1159.

2 Inamed Corporation’s McGhan Silicone-Filled Breast Implants, October 14-15, 2003, slides presented by the FDA, http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm

3 Brown SL, Pennello G, Berg WA, et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Journal of Rheumatology. 2001; 28:996-1003.

4 FDA Summary Memorandum, Inamed PMA Review Team, March 2, 2005., http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf

5 Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: an update. Epidemiology. 2006; 17: 162-169.

6 Brinton, LA, Buckley, LM, Dvorkina, O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004, 180: 619-627.

Teenagers and Cosmetic Surgery

Diana Zuckerman. “Teenagers and Cosmetic Surgery.” Commentary published in the online ethics journal of the American Medical Association
Virtual Monitor, March 2005.

In 2003, more than 223 000 cosmetic procedures were performed on patients 18 years of age or younger, and almost 39 000 were surgical procedures such as nose reshaping, breast lifts, breast augmentation, liposuction, and tummy tucks.2 As we consider under what circumstances plastic surgery is appropriate for teens, it is important to recognize that very few studies have been conducted to examine the risks for teens of these increasingly common procedures. Research is especially needed for the more controversial procedures such as breast implants, liposuction, and genital plastic surgery.

There is no question that reconstructive surgeries can benefit children and youth. Surgical procedures to correct cleft lips and palates, for example, are not controversial. Plastic surgery to correct unattractive facial features that can attract ridicule from other children, such as prominent noses and ears, are generally accepted in the United States. Cultural phenomena such as surgical makeovers on numerous television programs, however, make it increasingly difficult to agree on what constitutes a “normal” appearance and when the desire to improve one’s appearance is questionable or even crosses the line to psychopathology.3 In this commentary, I will focus on elective, cosmetic procedures on an otherwise healthy adolescent with no illness or defect.

Plastic Surgery in a Developing Teen
One of the concerns about plastic surgery on adolescents is that their bodies are still maturing. In addition to development that may occur in the late teens, growth charts indicate that the average girl gains weight between the ages of 18 and 21, and that is likely to change her desire or need for breast augmentation as well as liposuction. There are no epidemiological studies or clinical trials on the safety and long-term risks of these procedures for adolescents. Although the FDA approved saline breast implants for women ages 18 and older 4, it is legal for physicians to perform breast augmentation for anyone under 18 as an “off-label” use, and the number of teens 18 and younger undergoing breast augmentation tripled from 2002 to 2003. It was not until December 2004 that the American Society of Plastic Surgeons stated an official position against breast augmentation for patients under 18.

Understanding the Risks of Surgery
Will adolescents who want to improve their appearance rationally consider the risks? Studies by implant manufacturers report that most women have at least one serious complication within the first 3 years, including infection, hematomas and seromas, capsular contracture (a sometimes painful hardening of the breasts), loss of nipple sensation, and hypertrophic scarring.5 Since breast implants typically last 10 years, an adolescent will require repeated surgeries throughout her lifetime.6 Breast implants also interfere with mammography and increase the likelihood of insufficient lactation when a woman tries to breast-feed.

The economic costs of surgery are substantial, since corrective surgery is rarely covered by health insurance. With many plastic surgeons offering breast implants on the installment plan, our Center (National Research Center for Women and Families) is contacted regularly by young women who need to have a broken or painful implant removed but are still paying for the initial augmentation surgery and unable to afford corrective surgery.

Liposuction also carries potentially serious risks. Primary risks include infection, damage to skin, nerves, or vital organs, fat or blood clots (that can migrate to the lungs, leading to death), and excessive fluid loss that can lead to shock or death. In addition, the different techniques are associated with complications such as skin or deep tissue damage, lidocaine toxicity, and fluid accumulation in the lungs.7

The long-term physical, emotional, and economic sequelae of many popular cosmetic surgeries, including implants and liposuction, are unknown. Despite the documented risks, the general public has an inflated sense of the benefits and a minimized sense of the risks of plastic surgery.8 Teenagers are often oblivious to the well-documented long-term health consequences of smoking, tanning, and other risky behaviors, and are likely to pay even less attention to the risks of cosmetic surgery, making informed consent difficult.

In addition to the influence of persuasive and pervasive advertising and television makeover programs that stimulate demand, it is difficult for a physician to neutrally present both the risks and benefits of an elective procedure that he or she is simultaneously selling.9 Requiring parental consent for patients under 18 does not ensure informed consent, since research is lacking on long-term risks for many cosmetic procedures.

Screening
One way to help ensure that teenagers are mature enough to make decisions about plastic surgery is to screen potential patients using psychological testing. In media interviews, plastic surgeons often describe careful interviews aimed at determining why the teen wants plastic surgery. Unrealistic expectations or having the surgery to please a boyfriend is considered inappropriate, but having surgery so that “I will feel better about myself” or “clothes will fit better” are considered reasonable responses. By the same token, teenagers who use drugs, drive while inebriated, and have unprotected sex may also make those decisions to please themselves, and not others, so that response alone is not sufficient evidence of a mature decision. Currently, there is no evidence that effective screening is widespread.

Teen Self-Consciousness and Plastic Surgery
Teens expect that plastic surgery will improve their self-confidence, but does it? There are no empirical studies examining the long-term benefits among adolescents. One study found that body-image satisfaction improved after cosmetic surgery, but so did satisfaction among the control group, suggesting that improved body image may occur with increasing age, regardless of whether the patient undergoes plastic surgery.10 In fact, a longitudinal study that followed adolescents from age 11 to 18 found body image satisfaction rates were highest at age 18 in both sexes and that the satisfaction of individual participants varied as a function of their age and developmental stage.11 This indicates that many adolescents who are very dissatisfied with their appearance will feel more satisfied a few years later, whether or not they undergo surgery. The same study also found that the physical features with which participants were most dissatisfied reflected culturally determined stereotypes of idealized attributes emphasized in books, mass media, and advertisements.

Research indicating that breast augmentation patients are 4 times as likely to commit suicide compared to other plastic surgery patients12 raises questions about the mental health of the women who choose implants and the psychological benefits of the surgery. Liposuction is also of particular concern because of its association with eating disorders. The average onset of body dysmorphic disorder (BDD), defined as “a preoccupation with an imagined or slight defect in appearance that leads to significant impairment in functioning,” is 16 years of age.13 However, since the goal of cosmetic surgery is to improve and transform appearance, it may be difficult to distinguish between this desire and a pathological preoccupation.14

Who decides?
Will most plastic surgeons make an accurate and objective judgment about whether a teenage girl is an appropriate candidate for plastic surgery? If plastic surgeons are performing surgeries that many physicians and psychologists would question, should medical societies and ethicists provide more guidance than is currently being provided by plastic surgery associations?

In the ideal world, informed consent would enable teens and their parents to decide carefully what is best for them. However, in the absence of longitudinal research, it is impossible for physicians to warn patients, or their parents, about the risks of performing cosmetic surgery on bodies that have not reached maturation, the operative complications and long-term physical effects of these surgeries and the psychological implications of surgery on developing body image, or the extent to which distorted body image common among adolescence may result in the pursuit of plastic surgery.

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