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What You Need to Know About Breast Implants

Diana Zuckerman, PHD; Elizabeth Naglin-Anderson, MA; and Elizabet Santoro, RN, MPH, National Center for Health Research


In 2019, fewer than 300,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, a 4% decrease compared to 2018.  In addition, more than 100,000 breast cancer patients had reconstruction after mastectomy in 2019, often with implants.1 While the popularity of breast augmentation has tripled since 1997, when there were just over 101,000 of these procedure,2 recent trends show that fewer women are opting for augmentation.

There were also 54,539 implant removal procedures in 2019, including augmentation and reconstruction patients, compared to 48,385  in 2018 and 47,000 removals in 20171  The increasing number of women removing their implants can be attributed to several factors, including news stories highlighting the risks of breast implants, and the growing mass media and social media presence of patient advocates.  Most important, the growing awareness that breast implants can cause a type of cancer of the immune system, called Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) resulted in Allergan’s recall of their BIOCELL textured breast implants in 2019, efforts to notify women of the recall, and several insurance companies expanding their coverage to include explant surgery for women whose textured implants were recalled.

However, debate continues to swirl about the safety of breast implants. Here are the facts about what is known and not known about the risks of breast implants.

History of Implants in the US

Breast implants made with silicone envelopes and filled with silicone gel or saline (salt water) were first sold in the United States in the 1960s, but sales were relatively slow until the 1980s. By 1990, however, almost one million women had undergone breast implant surgery, even though no safety studies had been published. Most of those women had silicone gel breast implants, which the plastic surgeons preferred.

Although most medical products must be proven safe and effective before they can be sold in the U.S., that was not true for implanted medical devices sold before 1976.  The Food and Drug Administration (FDA) did not require that companies selling silicone breast implants prove that their implants were safe until 1991 – after they had been in use for almost three decades. For the first time, the media started to report about women with implant problems, and quoted doctors who were concerned about implant safety. When the studies were provided to the FDA, the safety data were found to be inadequate to warrant FDA approval.

The FDA did not require implant makers to prove that their saline implants were safe until 2000, when, despite high complication rates, the FDA approved saline breast implants for the first time.

Silicone gel breast implants were approved for the first time in November 2006. Between 1992 and 2006, silicone implants were restricted to clinical trials that were primarily for cancer patients and women with broken implants. The FDA required that patients be informed that the implants were not approved by the FDA and to be regularly evaluated by their plastic surgeons as part of the study, in order to provide safety data intended to help all women with gel implants. Unfortunately, there was no enforcement of that requirement and women who were enrolled in these studies to enable them to get breast implants were often not studied after the surgery.

Silicone gel breast implants made by two manufacturers were approved in November 2006, and gel implants made by one/two other manufacturers were approved subsequently.  There are still restrictions, however. For example, they are only approved for women over the age of 22, because younger women are still developing physically and emotionally and probably would not fully understand the risks.

In 2011, the FDA began tracking cases of a cancer of the immune system linked to textured breast implants, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Over the next several years, as studies were completed, FDA and medical experts recognized that rather than just being “possibly associated” with ALCL, breast implants caused ALCL, and that the risk was highest among women with textured breast implants. In 2019, Allergan recalled their BIOCELL textured implants worldwide following growing evidence of the greater risk of BIA-ALCL for women with those implants.  At the time of the recall, the FDA reported that 573 cases of BIA-ALCL worldwide had been reported since 2011, and this was increased to 733 in 2020.

What Are the Known Risks?

Reports of complications among women with implants have been published in medical journals and discussed at public FDA meetings. There are a number of short-term and long-term risks that any woman thinking about getting breast implants or about removing or replacing older implants needs to be aware of.

“Local complications” refer to problems that occur in the breast area that are obviously related to the breast implants or the surgery. Common complications include infection and other surgical risks, chronic breast pain, breast or nipple numbness, capsular contracture, breakage and leakage, necrosis (skin death), the need for additional surgery, and “cosmetic” problems (such as dissatisfaction with how the breast looks with the implant).

Studies of saline breast implants and silicone gel breast implants conducted by implant manufacturers have shown that within the first three years, approximately three out of four reconstruction (breast cancer) patients and almost half of first-time augmentation patients experienced at least one local complication – such as pain, infection, hardening, or the need for additional surgery.3

For example, among reconstruction patients:

  • 46% of women with silicone gel implants and 21% with saline implants underwent at least one re-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 experienced breast pain.4

Complication rates were lower, but still substantial, for augmentation patients. The FDA has a consumer handbook with descriptions of common complications as well as photographs, available to consumers here.

Among all reported complications related to breast implants, BIA-ALCL has been the most concerning, especially as reported cases continue to rise worldwide.  Since many physicians do not report problems with medical devices, reports to the FDA are considered “the tip of the iceberg.”  Therefore, it seems that BIA-ALCL is not “very rare.”  In the U.S., the most recent estimates place the risk of BIA-ALCL in textured implants between from 1.79 per 1,000 (1 woman with BIA-ALCL per 559 implants) to 2.82 per 1,000 (1 woman per 355 implants)5. There has been a dramatic increase in diagnoses of BIA-ALCL in recent years, indicating that BIA-ALCL was under-diagnosed and under-reported for many years, and that focusing on textured breast implants greatly increases the prevalence of BIA-ALCL compared to smooth implants..

In addition to the risks from anesthesia, surgical risks include infection and hematoma (blood collecting around an implant), both of which can range from mild to severe. Surgical risks are highest immediately around the time of surgery, but complications can require additional surgery later, which will have similar risks. A woman may need to face these surgical risks several times if she needs surgery to correct implant problems or has broken or damaged implants replaced with new ones.

Common local complications include loss of nipple sensitivity or painfully sensitive nipples. Some women are dissatisfied with the cosmetic results of breast implants, because their breasts look or feel unnatural or asymmetrical, or they can hear a “sloshing sound” from saline-filled implants. Problems like these can interfere with sexual intimacy.

Scar tissue that forms around any implant or foreign body can become hard or tight around the implant. This common problem is called capsular contracture. The scar tissue is inside the body, but it can cause the breasts to become very hard and misshaped, and it leads to discomfort that ranges from mild to severely painful.

Researchers have shown that bacteria or mold can grow in saline implants, and have expressed concerns about the bacteria or mold being released into the body if the implant breaks.6 What effect that might have on a woman, or a nursing baby, has not been studied.

What Happens When Implants Break?

All breast implants will eventually break, but it is not known how many years the breast implants that are currently on the market will last. Studies of silicone breast implants suggest that most implants last 7-12 years, but some break during the first few months or years, while others last more than 15 years.

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year.7 Silicone migrated outside of the breast capsule for 21% of the women, even though most women were unaware that this had happened.

Implant makers were required to study breakage and provide their studies to the FDA.  Short-term studies of today’s saline implants suggest that between 3-9% break within the first three years, and one implant manufacturer’s study of their silicone gel implants found that between 3-20% break within three years.3,8 A Danish study of ruptured silicone gel implants suggests that most implants last for ten years, but by the time they are 11-20 years old, most will break, and after 20 years the few that are still intact will break.9

Many women with silicone gel implants are unaware that their implants are broken or leaking.  Plastic surgeon Dr. Scott Spear and the former director of FDA’s Office for Women’s Health, Dr. Susan Wood, point out that “magnetic resonance imaging is the most accurate way to detect a rupture…Mammograms are often inaccurate in detecting rupture, and if an implant is already broken, the pressure from a mammogram could cause the silicone gel from the implant to leak outside the capsule.”10

Silicone Migration. Research has shown that silicone gel in implants can break down to liquid silicone at normal body temperatures, and there are reports of silicone leakage and migration from implants to the lymph nodes and other organs.11 What happens if liquid silicone migrates to the lungs, liver, or other organs? 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.12 This has potentially serious implications for women with breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants.

Do Breast Implants Make Women Sick?

A more controversial question is whether breast implants cause diseases or illnesses, in addition to ALCL and problems in the breast area.

Autoimmune, Connective tissue and Other Painful Diseases and Conditions.  Several reports published since the late 1990’s concluded that there is no evidence that implants cause systemic disease.13,14 These reports, however, often relied on research that focused on painful and autoimmune conditions and diseases in women who had implants for a relatively short time — ranging from a few months to a few years. Since these diseases may take many years to develop and be diagnosed, studies that include women who had implants for such a short time cannot be used to determine whether or not breast implants increase the long-term risks of getting these diseases.

Studies conducted after those initial reports were published indicated that implants might be linked to a number of diseases. For example, FDA scientists conducted a study of women who had silicone gel breast implants for at least seven years and found that those with implants that were leaking outside the scar tissue surrounding the implant were significantly more likely to report a diagnosis of at least one of several painful and debilitating diseases, such as fibromyalgia, polymyositis, Hashimoto’s thyroiditis, mixed connective-tissue disease, or pulmonary fibrosis.15  The risk of these diseases remained even after statistically controlling for patient’s age, implant age, and implant manufacturer.

Do implant patients who have autoimmune symptoms feel better if their implants are removed?  A study of 95 women who had silicone gel-filled breast implants and rheumatologic symptoms such as joint pain, found that the symptoms improved in 97% (42 of 43) of the women who had their breast implants removed. In contrast, rheumatologic symptoms worsened in 96% (50 of 52) of the women who did not have their implants removed.16 In addition, a university researcher has reported that silicone stimulates an immune response, and cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.17

A study of 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), and memory loss and other cognitive symptoms, compared to women of the same age in the general population.18

Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers, who were funded by a silicone manufacturer, concluded that long-term exposure to breast implants “does not appear to be associated with” autoimmune “symptoms or diseases.” However, the symptoms they reported can be from autoimmune diseases.

A report summarizing studies of breast implants was conducted by researchers hired by Tufts University and funded by The Plastic Surgery Foundation, which was supported by the 3 U.S. implant manufacturers.  This summary is notable for barely mentioning the studies quoted above.19

A study by MD Anderson Cancer Center researchers that was published in September 2018 in the medical journal Annals of Surgery, concluded that “silicone implants are associated with an increased risk of certain rare harms” and that further study is needed “to inform patient and surgeon decision-making.”20 The study included more than 100,000 women with implants, but is based on data from flawed studies conducted by two implant companies, Mentor and Allergan. Nevertheless, it is important to note that the researchers found that the risks of certain autoimmune diseases increased by 800% (Sjogren syndrome), 700% (scleroderma), and 600% (arthritis) for the women with Mentor silicone gel breast implants compared to the general population of women of the same age and demographics.  Stillbirths increased by 450% in the women who became pregnant.  Other autoimmune and rare diseases were also significantly higher among women with Mentor silicone gel implants.  These diagnoses were also statistically significantly higher for women with Allergan implants compared to the general population of women of similar demographics. Given the large percentage of women who were not in the study for more than 1 year, it is not possible to know how representative these findings are. However, these results raise important questions, especially now that it is known that breast implants can cause cancer of the immune system.

Will Explant Surgery Help Women with Breast Implant Illness Recover?

2020 study conducted by Dr. Lu Jean Feng and her colleagues also shows the risk of breast implant illness for women with breast implants, by studying the impact of explant surgery on women with breast implant illness symptoms. This study of 750 women, focused on 11 symptoms: 1) numbness and tingling in the extremities; 2) joint and/or muscle pain; 3) hair loss; 4) memory loss/cognitive problems; 5) dry eyes and/or blurred vision; 6) chronic fatigue; 7) breast pain; 8) rashes and/or hives; 9) food sensitivity/intolerance; 10) flu-like symptoms and/or low-grade fever; 11) difficulty breathing.  After the women had their implants removed, most reported a significant improvement in their health within 30 days. This was true for women with either silicone gel implants or saline implants21. Not all the women had all the symptoms prior to getting their implants removed, and some reported worse symptoms than others.  After the women had their implants removed, the women reported a statistically significant improvement in their health within 30 days. The highly significant results showed that this was a real difference, that did not happen by chance.  Improvements in symptoms occurred for women with either silicone gel implants or saline implants21

A 2021 study by many of the same physicians and researchers focused only on women who had reported “trouble breathing” prior to having their implants removed.22  There were 53 women in the study, and they had implants for an average of 12 years, including silicone or saline implants.  After their implants were removed, 100% of the women reported improvement in breathing.  Even more important, the physicians used 6 objective measures of “pulmonary function” that were compared before and after their implants were removed.  On half of those 6 measurements, the women showed statistically significant improvement.  In other words, the women reported improvement and those results were consistent with the evaluations conducted by the doctors using medically established objective measures indicating breathing difficulties.22

Do Breast Implants Increase the Chances of Developing Other Types of Cancer?

As mentioned above, breast implants can cause a type of cancer of the immune system called ALCL. There are also unanswered questions about cancer and implants. A study by National Cancer Institute (NCI) scientists found a 21% overall increased risk of cancer for women who had implants for at least seven years, compared with women of the same age in the general population.23 The increase was primarily due to an increase in brain, respiratory tract, cervical, and vulvar cancers. More research is needed to draw any conclusions, however.

There is no research evidence that implants cause breast cancer. However, implants can interfere with detection of breast cancer.

Mammograms have been shown to detect breast cancer earlier, potentially saving lives as well as saving women from needed mastectomies.  There are several ways in which implants have the potential to delay detection of breast cancer:

  • Although mammography can be performed in ways that minimize the interference of the implants, approximately 55 percent of breast tumors will be hidden in women with implants.24
  • FDA scientists report that silicone or saline implants can rupture when women undergo mammograms, and for this reason, women who fear implant rupture may forego mammograms.25
  • The accuracy of mammograms tends to decrease as the size of the implants increase in proportion to the size of the woman’s natural breast.

Patients have reported that their implants delayed their breast cancer diagnosis.24  Research findings have been inconsistent, but a 2013 Canadian systematic review of 12 studies found that women with breast cancer who had breast implants are diagnosed with later-stage cancers than women with breast cancer who did not have implants. This is likely due to delays in breast cancer detection because of implants. 26

A delay in diagnosis could result in the woman needing more radical surgery or the delay could be fatal.  A 2013 Canadian meta-analysis of five studies found that if women who had breast augmentation later developed breast cancer, they were more likely to die from it than women diagnosed with breast cancer who did not have breast augmentation. This increased risk of breast cancer-specific death is likely to be due to the greater inaccuracy of mammography for women with implants.25

An NCI study found that women who had breast implants for at least 12 years were more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared with other plastic surgery patients.27 Augmentation patients were not more likely to smoke than other plastic surgery patients, so the difference in respiratory diseases did not appear to be due to smoking. However, more research is needed to better control for relevant health habits. Three Scandinavian studies have reported that women who had breast implants for augmentation were three times more likely to commit suicide compared to women in the general population.28,29, 30

What Are Other Concerns?

Breastfeeding. According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding.12 Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue.  A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.30

Problems with Memory and Concentration. Women with implants have raised concerns about memory loss, difficulties with concentration, and other cognitive problems. FDA’s analysis of studies by implant companies found a significant increase in neurological symptoms, such as poor concentration, for women who had silicone implants for two years compared to their symptoms just prior to getting implants. These differences were maintained even when the women’s ages were statistically controlled.32 Some experts believe these symptoms could be related to the small amounts of platinum that are used to make silicone gel breast implants, since potentially toxic levels of platinum have been found in the blood and urine of women with implants.33

Unfortunately, there is no well-designed published epidemiological research to determine whether there is an association between these complaints and breast implants.

Financial Costs. Breast implant surgery is not a one-time cost. On average, implants last 7-12 years, and each replacement adds to the cost. Even if the implant itself is replaced for free, or if the surgeon offers his or her services for free, the cost of the medical facility, anesthesiology, and other expenses can still cost many thousands of dollars for each surgery.  These expenses are affordable for some women, but not for others, especially if the implant breaks after just a few months or years, or after a woman is divorced or loses her job.

When the FDA approved silicone gel breast implants in November 2006, it stated that women with these implants should have a breast MRI three years after getting silicone implants and every two years after that. 33 However, because of the expense and the reluctance of plastic surgeons to encourage MRIs for silent ruptures, very few women followed the FDA’s advice.  As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that. The purpose of the MRIs is to determine if the silicone gel breast implants are ruptured or leaking, because there are often no symptoms.33 Breast MRIs usually cost at least $2,000, and at some facilities they cost more than $5,000. It is important to remove silicone implants if they are ruptured, to avoid the silicone leaking into the breast or lymph nodes. That is an additional expense of at least $5,000, and can be $10,000 or more.

Saline implants do not require MRIs to check for leakage, and do not usually cost more than $5,000 to remove. The cost of MRIs and the additional cost of removing leaking silicone makes silicone implants substantially more expensive than saline.

What about health insurance? Typically, cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are also not covered.9 Health insurance will not pay for MRIs to check for silicone leakage for augmentation patients. In some states, major health insurance providers do not insure women with breast implants.9 Some insurers will sell health insurance to women with implants, but charge them more, and some insurers will not cover certain kinds of illnesses – or any problems in the breast area – for women with breast implants. Obviously, this can be a terrible problem for women who are diagnosed with breast cancer or any other illnesses that are excluded, whether or not those diseases are related to the implants.

What If I Need to Get My Implants Removed?

Women who have implants sometimes decide to have them removed because of complications, disappointment with how they look or feel, or concern about the long-term health risks. Some surgeons discourage patients from removing their implants. This may be because they don’t share the patient’s concerns, or because they know that some patients will be very unhappy with their appearance after the implant is removed. (See photo #3 here) Women with ruptured silicone implants often lose breast tissue as part of the removal surgery. If silicone has leaked into the breast tissue, the resulting removal surgery may be similar to a mastectomy. (See second photo here).

As noted in the earlier section about safety, many women report symptoms of “breast implant illness.”  After being tested to try to find a cause or treatment, an increasing number of these women are choosing to have their implants removed.  Fortunately, if the entire scar capsule and breast implants are carefully removed, most of these women find that their symptoms disappear or are greatly reduced.21,22

The plastic surgeon who performed the original surgery is not necessarily the best choice for removing the implant. Removal can be much more complicated and expensive than the original surgery, especially after a silicone gel implant has broken. Some plastic surgeons are very experienced at removal and are especially skilled at getting the best possible cosmetic result. Most surgeons who specialize in removal recommend removing the implants “en bloc,” which means that the implant and the intact scar tissue capsule surrounding it are all removed together. This helps remove any silicone that may have leaked from a broken gel implant, and also helps remove silicone or other chemicals that may have “bled” from the silicone outer envelope.

Are There Newer, Safer Implants?

As part of new research studies, plastic surgeons sometimes offer “gummy bear” breast implants, named after gummy bear candies because the implants are a thicker, more cohesive silicone gel. Since the shell and gel in these newer models are thicker than most other silicone gel implants, it is possible that they might be less likely to break or leak into the body.

Despite only 3 years of data provided by Silimed (Sientra) on relatively small numbers of patients, the FDA approved their “gummy bear” implants in 2012.  New implants often have risks that are not immediately obvious, and even after only 5 years of data were available, it was obvious that these gummy bear implants had similar types of complications  to other silicone implants. Only when the cohesive gel implants are in women for more than 10 years will we know whether and how the implant deteriorates or changes when it is in the human body.

Why long-term safety studies matter. In addition to silicone and saline implants, three other kinds of implants were developed and used primarily outside the United States: Trilucent implants (with soybean oil filler), and Novagold and PIP hydrogel implants, which were filled with a plastic gel.  They provide examples of why long-term safety studies are so important.

Although these implants were enthusiastically promoted by plastic surgeons and the media as a “natural” and safer alternative to silicone or saline implants, clinical trials were apparently never conducted on humans with these implants. By 2000, serious safety concerns resulted in the removal of all three from the market.34,35,36 The fact that they had been praised by doctors and patients when they were initially introduced serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use. That is why studies of the risks of long-term use – which are still lacking for silicone implants – are essential to establish the safety of all kinds of implants.

Conclusions

Research clearly shows that implants are associated with significant health, cosmetic, and economic risks within the first few years and these risks increase over time. Unfortunately, long-term risks remain unknown because of a lack of well-designed and carefully conducted scientific studies. When they approved silicone gel breast implants in 2006, the FDA required two implant manufacturers, Allergan and Mentor, to each conduct 10-year studies of at least 40,000 women  to determine why implants break, how long they can be expected to last, and what the longer-term health consequences of broken and leaking breast implants might be. Unfortunately, however, those studies were never completed and the FDA did not require the companies to substitute similarly well designed studies.

Related Articles

Study on Silicone Breast Implants and Unexplained Symptoms

Breast Implants and Cancer of the Immune System (ALCL): A History of Who Knew What When

Why are celebrities removing their breast implants?

For more information about breast implants, see www.breastimplantinfo.org.

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

References:

  1. 2019 Complete Plastic Surgery Statistics Report, American Society of Plastic Surgeons.
  2. ASAPS Percent of Change in Select Procedures: 1997-2004.American Society for Aesthetic Plastic Surgery (ASAPS), 2005. www.surgery.org. ASAPS estimates approximately 70,000 more augmentation surgeries in 2004 than does ASPS.
  3. FDA transcript of the Advisory Panel Meeting on Mentor Saline Breast Implants, testimony of Dr. Sahar Dawisha, pages 431-7, 441, at http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t1.rtf; FDA transcript of the Advisory Panel Meeting on McGhan Saline Breast Implants, testimony of Dr. Sahar Dawisha, pages 129-148, at http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t2.rtf. Local complications are even higher, and tend to be more serious, for women with silicone gel breast implants. See Inamed Corporation’s McGhan, Silicone-Filled Breast Implants, October 14-15, 2003, slides 39-42 and 49-51, at http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt
  4. FDA Summary Panel Memorandum of Inamed PMA, pages 21-22, at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed Panel Memo.pdf, Zuckerman D, Santoro E, Hudak N. Silicone Breast Implants: Illnesses and Complications, The Latest Research from Inamed’s Core Study at www.breastimplantinfo.org/what_know/oct03_summary.html.
  5. Lynch EB, DeCoster RC, Vyas KS, Rinker BD, Yang M, Vasconez HC, Clemens MW. Current risk of breast implant-associated anaplastic large cell lymphoma: a systematic review of epidemiological studies. Ann Breast Surg 2021;5:30
  6. Young VL, Hertl, CH, Murray PR, et al. Microbial Growth Inside Saline-Filled Breast Implants.Plastic and Reconstructive Surgery. 1997; 100: 182-196.
  7. Brown SL, Middleton MS, Berg WA, et al. Prevalence of Rupture of Silicone Gel Breast Implants Revealed on MR Imaging in a Population of Women in Birmingham, Alabama. Am J Roentgenol. 2000; 175: 1057-1064.
  8. FDA Summary Panel Memorandum of Inamed PMA, pages 21-22, at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed Panel Memo.pdf.
  9. Holmich L, Friis S, Fryzek J, et al. Incidence of silicone breast implant rupture. Arch Surg, 2003; 138: 801-6.
  10. Wood SF, Spear SL. What do women need to know and when do they need to know it? Plastic and Reconstructive Surgery, December 2007;120(7 Suppl 1):135S-139S.
  11. Katzin WE, Centeno JA, Feng LJ. Pathology of lymph nodes from patients with breast implants: A histologic and spectroscopic evaluation. Modern Pathology. 2002; 15: 246A. (abstract).
  12. James SE, Tarr G, Butterworth MS, et al. Silicone in the sputum after rupture of a calf implant. J R Soc Med 2001;94:133-134.
  13. Bondurant S, Ernster V, Herdman, R, eds. Safety of Silicone Breast Implants. Washington, DC:Institute of Medicine; 1999.
  14. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342:781-790.
  15. Brown SL, Pennello G, Berg WA, et al. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. J Rheumatology. 2001; 28:996-1003.
  16. Aziz NM, Vasey FB, Leaverton PE, et al. Comparison of clinical status among women retaining or removing gel breast implants. Presented at the American College of Epidemiology, 1998.
  17. O’Hanlon TP. Restricted and Shared Patterns of TCR b-chain Gene Expression in Silicone Breast Implant Capsules and Remote Sites of Tissue Inflammation. J Autoimmunity. 2000; 14: 283-293.
  18. Breiting VB, Holmich, LR, Brandt B, Long-term health status of Danish women with silicone breast implants. Plastic and Reconstructive Surgery. 2004; 114: 217-226.
  19. Balk, Ethan M, et al. “Systematic Review of Selected Adverse Outcomes and Symptoms in Women with Silicone Gel Breast Implants.” Tufts Center for Clinical Evidence Synthesis, Tufts Medical Center. https://www.brown.edu/academics/public-health/research/evidence-synthesis-in-health/sites/brown.edu.academics.public-health.research.evidence-based-medicine/files/uploads/Silicone%20breast%20implants%20Report.pdf
  20. MD Anderson. “Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases.” MD Anderson Cancer Center, University of Texas, www.mdanderson.org/newsroom/2018/09/largest-ever-study-shows-silicone-breast-implants-associated-with-rare-diseases.html.
  21. Wee, Corinne E et al. Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study. Annals of plastic surgery vol. 85,S1 Suppl 1 (2020): S82-S86.
  22. Wee, Corinne E. MD*; Younis, Joseph BS*; Boas, Samuel BS*;et al. The objective effect of breast implant removal and capsulectomy on pulmonary function. Plastic and Reconstructive Surgery – Global Open: June 2021;9(6): e3636. Retrieved from https://journals.lww.com/prsgo/fulltext/2021/06000/the_objective_effect_of_breast_implant_removal_and.57.aspx
  23. 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.
  24. Miglioretti DL, Rutter CM, Geller BM, et al. Effects of breast augmentation on the accuracy of mammography and cancer characteristics. JAMA, 2004; 291: 442-50.
  25. Brown SL, Todd JF, and Luu HD, Breast Implant Adverse Events during mammography: Reports to he Food and Drug Administration, Journal of Women’s Health 2004, 13: 371-378.
  26. Lavigne E., Holowaty EJ, Pan SY, Villeneuve PJ, Johnson KC, Fergusson DA, Morrison H, & Brisson J. Breast cancer detection and survival among women with cosmetic breast implants: Systematic review and meta-analysis of observational studies. British Medical Journal 2013: 346: f2339. doi: 10.1136/bmj.f2399.
  27. Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: An update. Epidemiology. 2006; 17: 162-9.
  28. 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.
  29. 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.], [end Jacobsen PH, Holmich LR, McLaughlin JK. “Mortality and suicide among Danish women with cosmetic breast implants.” Archives of Internal Medicine. 2004; 164: 2450. 
  30. Jacobsen PH, Holmich LR, McLaughlin JK. “Mortality and suicide among Danish women with cosmetic breast implants.” Archives of Internal Medicine. 2004; 164: 2450
  31. Maharaj SVM, & Lykissa ED. Total platinum in urine of women exposed to silicone breast implants and in their children conceived after implantation by ICP-MS. Abstracts of Papers, 230th National Meeting of the American Chemical Society, Washington, DC, United States, Aug. 28-Sept. 1, 2005. American Chemical Society, Washington, DC, 2005; ANYL 510.
  32. Inamed Corporation’s McGhan, Silicone-Filled Breast Implants, October 14-15, 2003, slides #45 and #55, at http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt.
  33. Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and
    Food and Drug Administration Staff, https://www.fda.gov/media/71081/download
     (For other identical MRI warnings for Mentor and reconstruction patients, see http://www.fda.gov/cdrh/breastimplants/labeling.htm).
  34. UK Department of Health, Medicines and Healthcare Products Regulatory Agency. “Device Alert – Breast Implants: NovaGold.” UK: Medical Devices Agency. www.medical-devices.gov.uk/.
  35. Laurance J, “Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer.” The Independent, 7 June 2000. www.independent.co.uk/story.jsp?story=5864.
  36. “Statement on the Safety of Trilucent Breast Implants.” UK: Medical Devices Agency. www.medical-devices.gov.uk/.

Former ‘Bachelorette’ Clare Crawley Is Removing Her Breast Implants Over Health Concerns—Here’s What to Know

Korin Miller, Health: July 06, 2021


Clare Crawley is opening up about her decision to have her breast implants removed over concerns they’re impacting her health.

The Bachelorette star shared the news in a video posted to Instagram that she titled, “Coming to Terms.”

“I’m sharing this in hopes that it might help others going through something similar feel not so alone,” Crawley, 40, wrote in the caption. “I feel that this was important to share so I can be a resource for anyone going through this as well. I know how being your own health advocate is hard sometimes, and can feel like an uphill battle. This is the reality of life for so many people though! I’m just so incredibly thankful to all the people who are in my life that support me not only in my peaks but in the valleys as well.”

In the video, Crawley revealed that she’s been struggling with persistent medical issues over several years. “I’ve been going through things medically with my body that I have not had answers to, to be honest,” she said. “My skin has been having really bad hives and rash. My whole body is just inflamed and itchy.”

Crawley said that she’s also had “blood test after blood test” and seen several doctors. But test results didn’t give her answers about what is going on in her body.

After having two mammograms and an ultrasound—which revealed what she said were sacs of fluid behind her implants—she consulted with her doctor and decided to have her implants removed. “As much as I love my implants, my body is fighting them and recognizes it as something obviously foreign in my body,” she said, adding that blood tests showed an elevated white blood cell count over the past few years. “My body can’t heal. My body is in fight mode, constantly. It’s exhausting, it’s frustrating. It’s all making sense.”

While Crawley said that her decision isn’t the right one for everyone, it’s what’s best for her. “My health is the most important thing. They are coming out,” she said.

Crawley received messages of support in the comments, including from Kayla Lochte, wife of Olympic swimmer Ryan Lochte, who shared in March that she had her implants removed over health concerns—specifically she specifically cited as breast implant illness (BII). “Best of luck Clare! Get those toxic bags out,” she said.

While Crawley herself didn’t specifically say that she has BII, she implies it. Here’s what you need to know about the condition—and what to do if you think your breast implants may be impacting your health.

What is breast implant illness, exactly?

It’s important to get this out of the way upfront: Breast implant illness (again, BII) isn’t a medical diagnosis, and there are no hard numbers on how often BII happens.

[….]

That said, the US Food and Drug Administration (FDA) concluded last year that breast implants should have a “black box” warning to help women make “informed decisions” about potential risks associated with breast implants, including BII, which the FDA labels as “systemic symptoms.” It’s also important to note that BII is different from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that can develop following breast implants, per the FDA.

BII is tricky to diagnose. “The symptoms women report are pretty nonspecific, and could be related to another illness,” Janie Grumley, MD, a breast surgical oncologist and director of the Margie Petersen Breast Center at Providence Saint John’s Center and associate professor of surgery at Saint John’s Cancer Institute in Santa Monica, Calif., tells Health. “It ends up being that, once we’ve worked out everything else and can’t figure out what’s going on, that’s when we think the issue may be breast implants.”

Research has suggested this is a real health concern. One July 2020 retrospective study published in the Annals of Plastic Surgery looked at 750 patients who had their breast implants removed by a surgeon over a two-year period. Researchers found that patients had “significant and sustained improvement” in 11 different symptoms after surgery. Patients found their symptoms improved within 30 days after having their implants removed.

Another study published in the same journal in January 2019, found that people with silicone breast implants had higher rates of the autoimmune conditions Sjogren syndrome, scleroderma, and rheumatoid arthritis than those who don’t have implants. They also had a higher risk of stillbirth and melanoma.

Why might breast implants make some people sick?

“All breast implants have a silicone shell that also contains various chemicals and small amounts of heavy metals,” Constance M. Chen, MD, a board-certified plastic surgeon and breast reconstruction specialist, tells Health. “Some breast implants also have a silicone filling that can leach off an intact implant or spill out of a ruptured implant. The silicone, chemicals, and/or heavy metals in the body can make some women sick.”

[….]

Scar tissue usually develops around the implant inside the body in an attempt to protect it from the “invader,” Diana Zuckerman, PhD, president of the National Center for Health Research who has researched breast implant safety, tells Health. “For some women, the scar tissue provides the protection they need, and they feel fine,” she says. “For other women, their bodies react more strongly, with an autoimmune reaction or other kind of reaction.”

What should you do if you suspect your implants might be causing your health issues?

You should talk to your doctor, Dr. Grumley says. Just know this, per Dr. Zuckerman: There’s no test that can tell if the implants are making you sick while they’re still in your body. But, she says, “if women find that they are developing symptoms that don’t go away, they should consider getting their implants and the scar capsule removed.”

It’s important to see a doctor who has experience in breast implant removal, Dr. Zuckerman says. Not only do they know what they’re doing, they’ll also know to remove the scar tissue that’s formed, which can contain silicone gel. If they don’t, “the chances of your health improving is not as good,” she explains.

[….]

To read the entire article, click here.

Tips for Testifying at the Breast Implant FDA Meeting


The National Center for Health Research is available to help patients edit their public comments before the FDA Advisory Committee. Our organization has decades of experience testifying at FDA meetings regarding breast implants and other medical devices, so we’ve seen great patient presentations and ones that were not effective at all.  For example, it’s important to keep in mind what kinds of patient experiences  the FDA will consider, and to not rush your statement.  These tips should help!

Specific Tips for Testifying at the Breast Implant FDA Meeting
  1. The patient voice is important so if you are a patient, please testify as a patient. Don’t try to testify as a scientist or medical expert, unless you are a professional in that field.  If you are both a medical professional and patient, be sure to say so in your first or second sentence.
  2. If you were in a clinical trial for breast implants be sure to say so.  Did the doctor ever follow up with you to include data on your health in the years after your surgery?  If you told your plastic surgeon of your health problems, were you no longer contacted for the study?
  3. Focus on the issues that the FDA cares about.  They have made public those 7 issues:  BIA-ALCL; Breast implant illness; Use of registries for implant surveillance; MRI screening for silent silicone gel rupture; Use of surgical mesh in breast procedures; Use of real-world data and patient perspectives in decision making; and Informed consent.
  4. Do NOT talk about how terribly your doctor treated you.  That is not the jurisdiction of the FDA, so they just won’t listen.
  5. Do NOT list all of your symptoms.  List a few and focus on how the worst ones have affected the quality of your life and health.
  6. Do NOT get into a discussion of the chemicals in breast implants unless you are a chemist.
  7. Do NOT insult FDA or doctors. If you point out that FDA and doctors need to better inform patients of the risks, etc, that would be more persuasive than insults.
  8. Did your doctor assure you that your health problems were unrelated to your implants? As a result, did you delay getting the medical care you needed?  What could FDA do to better educate doctors about implant health problems?
  9. Did your health problems start immediately or gradually over the years?  (If the latter, point out that’s why long-term studies are needed).
  10. Did your plastic surgeon ask you if you had any autoimmune symptoms or diagnoses before getting implants?  If the plastic surgeon knew you had such medical problems, did he tell you that breast implants were not studied by the implant manufacturers on women with such medical issues?
General Tips for Testimony Presentations
  • Decide on one clear message and make that message clear early and perhaps often – don’t make it a surprise at the end because they may miss it.
  • Clearly state your main points – preferably no more than 3.
  • Use simple sentence structure – it’s easier to follow.
  • Time yourself speaking out loud and make sure your statement/presentation is significantly SHORTER than the time allotted so that you WON’T need to rush and WILL have time for eye contact.  There is nothing worse than testimony that is read too quickly.

How to keep your statement short?  Take out extraneous examples, use words with fewer syllables (each syllable takes a second to say), don’t make side comments (weather, how nervous you are, etc.) that you hadn’t planned on.

 For example: Mr. Chairman, Members of the Committee, I want to thank you for the opportunity to testify today. = 29 syllables.

Thank you for the chance to speak today  = 9 syllables and just as polite.  You have thanked them and they already know who they are, you don’t have to remind them.

Opportunity = 5 syllables.   Allowing = 3 syllables.  Chance = 1 syllable.

If You Are Using PowerPoint
  • If you use PowerPoint give enough time for your audience to understand EACH Slide.  If you don’t have time to do that, take the slide out.
  • Use graphics (cartoons, photos, humorous drawings, simple graphs) to illustrate your points. A picture is worth a thousand words– that’s really what PowerPoint is for.
  • PowerPoint with lots of words is not an effective or entertaining presentation and not an effective way to share ideas.
  • Slides with words should be simple without a lot of background decoration or other distractions.
Example Format for Testimony  (Fill in the blanks)

My name is ___ and I traveled from STATE at my own expense, so I have no conflicts of interest.

Thank you for the chance to share my story with you.

I first got breast implants at the age of ___ because I ____ (very briefly mention reason).

The health issues started __ months (or years) later, but I didn’t realize it was related to my implants. [Briefly describe your symptoms in one sentence, such as “I was exhausted all the time, my hair was failing out, and I couldn’t concentrate.”]  My doctors told me ________.

I didn’t know what was wrong, but when I read about the experiences of other women online, I __________.

I got my implants out in YEAR and my symptoms [did or did not improve, gradually or immediately].  (describe briefly)

I know from experience that breast implants can harm women’s health.  Doctors and women need to be warned about the health problems that breast implants can cause.  It would help if the FDA warned them.  [Some of the women plan to say: The patients need a short, easy to read check list, like the 2-page check list that was required for Essure patients last year.]

OR:  One of the questions you’ll be voting on is ____.  I urge you to listen to my experiences and vote ____.

 

Letter for Breast Pain

Here is our sample letter of medical necessity written for a woman who has chronic breast pain or back pain caused by the weight of her implants, but does not have capsular contracture (her breasts do not feel hard). If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click Here to download this letter as a word document that you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. [Patient name] has reported chronic breast pain. [Patient name] requires an explantation with permanent removal of both implants. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female with chronic breast pain. [Patient name] has been in my care since [date]. As a result of her pain, my patient has experienced significant deficits in her daily functioning, including [not being able to reach above her head, etc]. She has previously tried [any pain medications, including Tylenol] to relieve her pain. The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

In addition to her chronic pain on a daily basis, undergoing mammography has become too painful and the results are too inaccurate. Breast implants can interfere with the accuracy of mammography because the implant can hide breast tumors so that they are not visible on the mammogram. Inaccuracy is exacerbated when the patient has breast pain, as [Patient name] does. The lack of accurate mammograms makes it difficult to diagnose breast cancer at an early stage when it can be treated more effectively and with less radical treatments. Removal of her breast implants will allow her future mammography screenings to be much less painful and much more accurate.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has severe pain that has negatively impacted her daily functioning. Her severe breast pain keeps her from [lifting her arms above her head, getting dressed, sleep, add relevant tasks]. Surgical implant removal is the standard treatment for breast pain and capsular contracture, and is clinically appropriate for my patient’s illness. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

[RELEVANT POLICY LANGUAGE].”

[Patient name]’s severe breast pain meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of her breast implants and scar tissue surrounding them will relieve her breast pain and improve her daily functioning. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [Patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports

 

Letter for Capsular Contracture

Here is our sample letter of medical necessity written for a woman with hard or painful breasts caused by capsular contracture (classified as Baker III or IV). If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click Here to download this letter as a word document you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. I have diagnosed [patient name] with [Baker III/IV] capsular contracture and severe breast pain. [Patient name] requires an explantation with permanent removal of both implants. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female with [Baker III/IV] capsular contracture and severe breast pain. [Patient name] has been in my care since [date]. As a result of her pain, my patient has experienced significant deficits in her daily functioning, including [not being able to reach above her head, etc.]. I diagnosed her with chronic pain resulting from her breast implants. She has previously tried [any pain medications, including Tylenol] to relieve her pain. The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

In addition to my patient’s chronic pain on a daily basis, undergoing mammography has become too painful and the results are too inaccurate. Breast implants can interfere with the accuracy of mammography because the implant can hide breast tumors so that they are not visible on the mammogram. Inaccuracy is exacerbated when the patient has severe capsular contracture, as [Patient name] does. The lack of accurate mammograms makes it difficult to diagnose breast cancer at an early stage when it can be treated more effectively and with less radical treatments. Removal of her breast implants will allow her future mammography screenings to be less painful and much more accurate.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has severe capsular contracture and breast pain. Her significant breast pain prevents her from [lifting her arms above her head, getting dressed, add relevant tasks]. Surgical implant removal is the standard treatment for chronic breast pain and capsular contracture and clinically appropriate for my patient’s illness. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

RELEVANT POLICY LANGUAGE

[Patient name]’s [Baker III/IV] capsular contracture and breast pain meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of both her breast implants and scar tissue surrounding is the standard treatment to relieve her severe breast pain, eliminate her capsular contracture, and improve her bodily functioning. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [Patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports

Letter for Ruptured Silicone Gel Implants

Here is our sample letter of medical necessity written for a woman with at least one ruptured silicone gel breast implant. If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click here to download this letter as a word document you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. [Patient name] has undergone [MRI/ultrasound/mammogram/a comprehensive clinical exam] and there is clear evidence that [her right/ her left/both her] silicone gel breast implant[s] [is/are] ruptured. [Patient name] requires an explantation with permanent removal of both implants and scar capsules. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female who has been in my care since [date]. [As a result of her ruptured implant[s], my patient has experienced [pain] as well as significant deficits in her daily functioning, including [not being able to reach above her head, etc.]. [She has previously tried [any pain medications, including Tylenol] to relieve her pain.] She is unable to safely undergo mammography to screen or diagnose breast cancer, because the pressure of the procedure would spread the leaking silicone throughout the breast area and surrounding tissue and potentially to her lymph nodes, and from there to organs such as the lungs and liver. In
addition, even without mammography the leaking silicone [has migrated/can migrate] to her lymph nodes and from there to other organs, and [has resulted/can result] in the formation of granulomas that resemble lumps caused by breast cancer tumors. The FDA and general expert consensus have recommended explantation for all patients with both extracapsular- and intracapsular-ruptured silicone gel breast implants.

The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has [a] ruptured silicone gel implant[s]. Surgical implant removal is the standard treatment for a ruptured silicone gel implant and clinically appropriate for my patient. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

[RELEVANT POLICY LANGUAGE]

[Patient name]’s ruptured silicone gel implant[s] meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of both her breast implants and intact scar tissue surrounding them is needed to prevent silicone gel leakage during the explantation surgery. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports