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Are Your Breast Implants Poisoning You?

Johane van den Berg, Longevity. June 18, 2018.

Victoria Beckham, Crystal Hefner, Pamela Anderson, Yolanda Hadid, Melissa Gilbert and Heather Morris. What do these famous women have in common with thousands of other women worldwide? Well, for one thing, they all decided to get breast implants when they were younger. And now all of them have decided to remove what many are referring to as their “toxic bags”.

After their arrival on the cosmetic-surgery market in the 1960s, both silicone and saline breast implants quickly became the most popular plastic surgery procedure for women. According to the American Society of Plastic Surgeons, breast augmentation is still the number one surgical procedure for women, ranking above liposuction, nose reshaping, eyelid surgery and the tummy tuck. The problem, explains Dr Diana Zuckerman, Ph.D. and President of the National Centre for Health Research in the United States, is that surgeons who administer breast implants often minimize the risks associated with this procedure. Consequently, the majority of women don’t realize that a few years after the procedure, they may need to have their implants removed. Additionally, they are unaware that removal costs at least as much as implantation.

This is despite the fact that various official organizations warn that breast implants should not be regarded as lifetime devices. The FDA in the US, for example, explains that the longer you have breast implants, the more likely it will be for you to have them removed. In addition, their list of risks associated with this procedure is extensive and detailed, ranging from chest wall deformity to toxic shock syndrome.

Now, about 50 years after breast implants were first introduced globally, un-tracked numbers of women are complaining of a recognizable pattern of health problems, which they attribute to their implants. Those suffering from these symptoms generally refer to the condition as Breast Implant Illness or BII (although non-medical, this term is widely used). Various social media groups and organizations have been formed by these women, most notably Healing Breast Implant Illness and The Implant Truth Survivors.

Symptoms of this condition – which Dr Zuckerman explains, is a pattern of health problems likely caused by an autoimmune reaction to the implant – include mental confusion, joint pain, hair loss, dry eyes, chronic fatigue, and persistent flu-like symptoms. “In some cases,” she says, “silicone gel is leaking into their bodies and causing the autoimmune reaction. When the gel leaks into organs such as the lungs and liver, it can’t be removed surgically.”

In addition, a lot of women experience what is called capsular contracture. This occurs when the scar tissue around the implant (inside the body) gets tight and hard. This can make the breasts look abnormal and cause chronic pain and hardness.anti-aging & breast implants

But aren’t breast implants supposed to be a safe procedure?

“In the context of health and longevity, it is urgent to dispel many current misconceptions about breast augmentation and other implant-based cosmetic surgery procedures,” says Dr Pierre Blais. He is considered to be the world’s foremost expert on breast implants as failed medical devices. He is also a former Canadian Government researcher and Senior Scientific Advisor.

Dr Blais explains that, because implants are designed to be temporary devices, they degrade chemically and wear out, eventually releasing their content.

“The process is silent and insidious, as the released substances are aggressive and some are outright toxic or infective (for saline implants). Thus, with ageing, the implant site undergoes destructive anatomic and biochemical changes – termed necrosis – as tissue dies and solubilized proteins become denatured.”

Moreover, in one of his papers on the topic, Dr Blais determines that implants can injure without undergoing mechanical failure. Studies on long-term implant users indicate that, in the pectoral and intercostal areas, gradual and irreversible deterioration of muscle function takes place. Respiratory problems are widespread among implant users, as are complications affecting major lymphatic ducts and fluid irrigation of the upper chest.

Dr Blais has tested thousands of explanted tissue samples and capsules, finding that they are prone to not only various types of bacteria, but also yeast and mold.

How do implants contract these bacteria?

Although saline-filled implants are presented and regarded as the “safe” option compared to silicon – containing only salt and water – they are rarely hermetically ‘sealed’. Moreover, their filling valves aren’t perfectly secure. As a result, they allow the body fluids of the user to infiltrate, along with bacteria, yeast and molds. After this happens, decaying elements will start building up. When the shell eventually starts leaking into the user’s chest, the contaminated contents is discharged and spread through the body.

Indeed, if given enough time, anyone who has breast implants will start to experience these symptoms. Dr Blais describes this as a form of local, accelerated biochemical ageing. Eventually the site of the implant will start to resemble a large chronic abscess, and secondary corrective surgery will be required in any case.

This is why, he explains, athletes and entertainment professionals who undergo breast augmentation, can expect a drastic decrease in stamina, appearance and comfort during their late career. This is known in medical and paramedical circles and explains why breast implants are sometime called “the time bandits”.

According to an investigation involving a number of different patients done by CBS 5 – who also worked with Dr Blais to determine the validity of this condition – after explant, almost all of the autoimmune symptoms eventually disappear.

Are there any forms of breast implants that are considered safe?

“There are no breast implants on the market that never cause side effects or complications,” says Dr Zuckerman. “In general, breast implants filled with saline are less likely to cause serious injury than those filled with silicone gel, but we know many women who have become ill because of saline implants.”

Often, when a woman chooses to undergo this procedure, she is persuaded by her plastic surgeon (or breast surgeons after mastectomy) that breast implants are safe devices. Although there are thousands of stories of women whose health deteriorated as a result of their implants, the voice a plastic surgeon will more than often outweigh the information. This is because patients tend to hear what they want instead of making a decision based on information from both sides.

“Then, when women experience these complications,” explains Dr Zuckerman, “they are furious at themselves for making a decision based on limited information and furious at their doctors for not warning them of the risks. The women who are most harmed by breast implants are the ones that don’t realize that their health is deteriorating because of their implants, or don’t have $8,000-10,000 to get their implants removed by an experienced explant surgeon.” […]

 

Read the original article here.

Capsular Contracture


After getting breast implants, breast pain, hardness, and numbness can develop and last for years. These common complications may never go away. The most common complication of breast implants is capsular contracture. When you get breast implants, your body naturally responds by forming scar tissue around the implants. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the implant to harden and become very painful. It can also change the shape of the implant, making it look abnormal, as shown in the photo below.

A 29-year-old woman with Baker Grade IV capsular contracture. Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

To fix capsular contracture, doctors used to perform a “closed capsulotomy.” This painful procedure involves squeezing the breast very hard to break the scar tissue capsule. This procedure should never be done. Most plastic surgeons do not perform this procedure anymore, but some do. The squeezing can break the implant and the capsule. Closed capsulotomies are not effective, and capsular contracture often comes back.

There are different grades of capsular contracture (Baker I, Baker II, Baker III, and Baker IV). They are graded based on the severity of symptoms:

Baker Grading System for Capsular Contracture

Baker I Breast is soft
Baker II Breast is slightly firm
Baker III Breast is firm and possibly misshapen and uncomfortable
Baker IV Breast is hard, painful, and misshapen

Health insurance companies that will pay for breast implant removal usually cover removal when there is severe capsular contracture (Baker III and Baker IV). This is because severe, painful capsular contracture interferes with mammography (breast cancer screening). It can also interfere with daily activities, such as reaching above your head.

The same 29-year-old woman as above one year after her implants were removed and not replaced. Think of how much pain she was in to be willing to look like this! Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

Capsular contracture does not usually get better by itself. If your breasts become very painful or hard, you will need surgery. Your surgeon would need to remove the scar tissue capsule and the implant. It is possible that some of your own breast tissue will be removed during the surgery because it is attached to the scar tissue. This can reduce the size of your natural breast and/or change their appearance.

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

 

Rupture


If an implant tears or develops a hole, it is called a rupture. Some implant ruptures happen during the first few months, but the older an implant is, the more likely it is to rupture. It’s not always obvious when an implant has ruptured. Here’s what you need to know.

Saline Implant Ruptures

When a saline (salt water) breast implant ruptures, it will probably leak very quickly. The implant deflates much like a balloon that has lost the air inside. As this happens, your breast will change in size and/or shape. If a saline implant leaks slowly, it might not be immediately noticeable. When the saline leaks, the body absorbs it. It is usually harmless unless bacteria, yeast, or mold are inside the implant. They can cause a serious infection. If you notice a change in the size or shape of your saline implant along with symptoms like swelling, redness, or fever you should see a doctor immediately.

Silicone Implant Ruptures

When a silicone gel breast implant ruptures, it usually leaks very slowly. A ruptured silicone gel implant may not be obvious for many years. This is why silicone gel implant ruptures are sometimes called “silent” ruptures. Sometimes, the rupture is discovered only when the implant is removed.

When a silicone implant ruptures, the silicone can either stay inside the capsule (the thick layer of scar tissue that naturally grows around the implant) or it can leak outside the capsule. It is more serious when the silicone leaks outside of the capsule. When this happens, silicone can migrate to the lymph nodes, and from there can go to the lungs, liver, or other organs where it’s impossible to remove. The longer a woman waits to have a ruptured silicone gel implant removed, the more silicone is likely to leak inside her body and cause health problems.

How Do I Find Out If My Silicone Implant Has Ruptured?

If your silicone gel implant ruptures, you might notice a change in the size or shape of your breast. You might feel pain or tenderness, swelling, numbness, burning, or tingling. Or, you might not have any symptoms, making it impossible to know you have a rupture.

Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends having a breast MRI 3 years after getting breast implants. After that, a breast MRI should be done every other year to check for a rupture.

A mammogram is the least accurate way to diagnose a ruptured silicone-gel breast implant. In addition, the pressure could cause the silicone to leak outside the capsule.

What Should I Do If My Implant Ruptures?

If your saline implant has ruptured, you should see a doctor. This is especially important if you feel sick, have a temperature, a rash, or other unexplained symptoms. You could have an infection and require treatment.

If you have ruptured silicone gel implants, they should be removed as soon as possible. The longer the silicone is allowed to remain in the body, the more time it has to migrate to other parts of your body. Once the silicone has moved to other parts of your body, it can’t be removed and may cause other health problems.

Since breast implant removal includes costs (such as anesthesia) that are similar whether you have one implant removed or two, it is usually best to remove them both at the same time, whether or not you want them to be replaced. For example, if your implants were put in at the same time, and one is ruptured, it is likely that the other will rupture soon. One surgery is much less expensive than two.

Can Broken Implants Make Me Sick?

According to research by FDA scientists, women with leaking silicone implants are more likely to report fibromyalgia (widespread body pain and fatigue) or several other diseases, compared to women whose implants are not leaking.1 One study found that 3 out of every 4 women who removed their silicone breast implants saw improvement in their symptoms.2

No research has been published on the health risks of broken saline implants but bacteria from ruptured saline implants have caused women to become ill.

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

Pregnancy and Breastfeeding Concerns


When considering whether to have breast implant surgery, you should take your future plans for childbearing and breastfeeding into consideration.

Pregnancy

Although some researchers believe that having breast implants may harm a growing fetus, there is a lack of research to determine if this is true. Researchers who believe that implants can result in autoimmune issues or birth defects in children have several theories: 1) silicone molecules travel through the placenta from mother to baby, 2) mothers form antibodies from silicone exposure that transfer to their fetuses, and 3) autoimmune issues experienced by the mother are inherited by the baby.[1] However, there are not enough well-done studies to prove that any of these theories are true.

There are other reasons why women who are planning to get pregnant may want to avoid breast implants. Pregnancy can cause drastic changes in breast size and shape, so having implants may affect the shape of breasts after the baby is born. When breast implants are initially placed, the surgeon normally uses the natural shape of the breast as a guide. After pregnancy and breastfeeding, implants may no longer enhance the look of the breast in the way that they did before.

Breastfeeding

Breastfeeding has many health benefits for an infant, including immune strengthening, neurological development, and nutritional intake. Additionally, the skin-to-skin contact during feeding promotes bonding between a mother and child. Studies indicate that women with breast implants may find it difficult to produce enough milk due to pressure on the milk ducts from implants or damage to mammary glands or ducts during the implant surgery. For example, several studies show that women with implants were more likely to need to supplement their baby’s diet with formula, because they were unable to produce enough breast milk to feed their baby.[2] This information is important for any woman who plans to become pregnant in the future, and especially for women who previously had difficulty with breastfeeding.

Mothers with silicone implants have expressed concern that silicone could get into their breast milk. However, researchers are not certain whether silicone leaking out of an implant could be ingested by an infant during feeding.

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

References

  1. Bondurant, S, et al. “Safety of Silicone Breast Implants.” National Academies Press, 1999, www.ncbi.nlm.nih.gov/books/NBK44782/
  2. Schiff, M., Algert, C., Ampt, A., Sywak, M., & Roberts, C. (2014). The impact of cosmetic breast implants on breastfeeding: A systematic review and meta-analysis. International Breastfeeding Journal, 9(1), 17-17. doi:10.1186/1746-4358-9-17

Complications of Saline Breast Implants

Elizabeth Nagelin-Anderson, MA and Diana Zuckerman, PhD, National Center for Health Research

What You Should Know Before You Decide on Reconstruction

How risky are breast implants? This is a controversial question, but implant manufacturers have done research showing that local complications, including pain, rupture, and the need for additional surgery, are very common within the first three years.

The FDA required breast implant manufacturers Mentor Corporation and Inamed Aesthetics (formerly called McGhan) to conduct research on the complications of saline breast implants for breast reconstruction and breast augmentation patients. The purpose of this research was to provide women with information so that they can make a more informed decision about whether or not they want saline breast implants. This information is supposed to be made available by plastic surgeons to all patients before they make their decision. The studies did not include diseases or conditions such as cancer, lupus, or fibromyalgia.

This issue brief is based on the FDA’s analyses of data collected by Mentor Corporation and Inamed Aesthetics. It is based on research, not opinion. The 3-year data were analyzed by the FDA in 2000 and the 5-year data were analyzed in 2002. This fact sheet is only about reconstruction patients.

Mentor Saline Implants

Mentor conducted a 5-year study on reconstruction patients. Unfortunately, so many women (almost 60%) dropped out of the study before the five years were completed, that the information is not reliable. For that reason, we are only providing the information collected during the first 3 years after getting implants, which included 78% of the patients.

Important Points from the Mentor Data

  • Most women can expect at least one complication within the first 3 years.
  • 40% of reconstruction patients can expect to have additional surgery within the first 3 years.

Mentor Reconstruction Patients 3-Year Complication Rate

Reconstruction patients experienced the following problems within the first 3 years of receiving their implants:
Table of Reconstruction Patient Complications after Three Years
Only 78% of the reconstruction patients who originally enrolled in the study completed all 3 years. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher.

Inamed Saline Implants

Inamed, formerly called McGhan, conducted a 5-year study on breast reconstruction patients. They collected information at the 3-year point from 71% of the reconstruction patients who originally enrolled in the study.

At the 5-year point they collected information from 57% of the reconstruction patients. This is a problem, since no information is available for 43% of the patients. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher, and the 3-year data are more reliable than the 5-year data.

Important Points from the Inamed Data

  • Most women can expect to experience at least one complication at some point within 5 years after implant surgery.
  • 40% of reconstruction patients can expect to have additional surgery within the first 5 years.

Inamed Reconstruction Patients 3-Year and 5-Year Complication Rates

Reconstruction patients experienced the following complications during the first three years and first five years after surgery.
Complication Rates for Reconstruction Patients at 3 and 5 Years

*Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Most complications for Inamed patients through the first 5 years are similar to those reported after the first 3 years. Since it is well known that some complications, such as rupture and capsular contracture, increase over time, women with complications were apparently more likely to leave the study than those who continued. Some of these women have left their plastic surgeons and could not be contacted.

References

Read the mentor educational brochure here

Read the Inamed publication on making an informed decision here

Read the FDA’s list of potential local complications here

Read the FDA’s warning about ALCL here

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

 

What to Ask Your Plastic Surgeon


When you’re considering breast implants, it is often hard to know what questions to ask and who to ask. For many plastic surgeons, breast augmentation is a large part of their practice and their salary. Keep in mind that you may not receive completely objective responses, but here’s a good place to start:

Before you go in, make sure the plastic surgeon is very experienced in breast augmentation. Any physicians or dentists may call themselves cosmetic surgeons even if they aren’t well trained in surgery. That’s perfectly legal, but their patients are taking a risk.

Ideally, you will want to see a plastic surgeon who is board certified in plastic surgery (not in some other medical specialty), because that will help assure you that they received the appropriate training to perform breast augmentation. You can find out if a doctor is board-certified by the American Board of Plastic Surgery online.

However, not all board certified plastic surgeons are skilled at implanting or removing breast implants. Check online for complaints about any plastic surgeons that you are considering. If there are serious complaints about patients who were harmed by the surgeon, look for a plastic surgeon with better ratings.

Once you decide to see a surgeon, here are some questions to ask during your appointment:

  • Ask to see before and after photographs of your plastic surgeon’s patients. Some doctors use photographs of patients whose surgery was done by other surgeons. If the doctor says that the photos are of his/her patients, ask when those patients had surgery. If it was a long time ago, ask to see more recent photos.
  • Ask to see photographs of her or his patients that were taken at least three years after the surgery. Many patients look good immediately after surgical scars have healed but their breasts look different years later.
  • Ask your doctor for a patient booklet or other written information that includes the risks of breast implants and read that information at least one week before surgery so you have time to ask questions and gather more information.
  • Ask for a copy of the informed consent form at least one week before surgery.
  • Ask whether there is a warranty on the implants and, if so, what is and isn’t included.
  • Ask whether the doctor will remove your implants for free if you have serious problems. If so, will the surgical center services also be free? What if you want them removed, but the doctor doesn’t think it is necessary?

If you’re still unsure about getting breast implants, seek advice from someone that has gone through breast implant surgery at least 5 -10 years ago. They may be able to help you make the decision that is best for you. Click here to read some personal stories from women who had breast implants.

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

Crystal Hefner Shares The Health Problems Breast Implants Can Pose

Bruce Y. Lee, Forbes: July 24, 2016

Crystal Hefner, formerly Crystal Harris and the 30-year-old Playboy model and wife of Playboy founder Hugh Hefner, announced the recent removal of her breast implants by […] sharing a post on Facebook that began, “My Breast Implants Slowly Poisoned Me.” She rattles off a litany of health problems that she says she suffered from the implants such as:

  • Intolerance to foods and beverages
  • Unexplained back pain
  • Constant neck and shoulder pain
  • Cognitive dysfunction (brain fog, memory loss)
  • Stunted hair growth
  • Incapacitating fatigue
  • Burning bladder pain
  • Low immunity
  • Recurring infections
  • Problems with my thyroid and adrenals.
  • Days in 2016 when I couldn’t get out of bed.

She explains that at first she was diagnosed with Lyme disease and toxic mold, but then learned via social media that her symptoms resembled “breast implant illness.”

After visiting a breast implant illness website and Facebook group with almost 3,000 members, she realized that her symptoms matched. On June 15th, 2016, plastic surgeon Dr Lu-Jean Feng removed Hefner’s breast implants. […] Her Facebook post continues: ”Instantly I noticed my neck and shoulder pain was gone and I could breathe much better. I know I won’t feel 100% overnight. My implants took 8 years to make me this sick, so I know it will take time to feel better. I also have other illnesses to address, but with the toxic bags removed, my immune system can focus on what it needs to.” […]

Read the original article here. 

Breast Implants: A Research and Regulatory Summary

Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, and Judith Faucette, JD: February 2011

Despite the impact of the battered economy on plastic surgery, breast implants remain very popular. In 2009, nearly 290,000 women and teenagers underwent breast implant surgery for augmentation and approximately 86,000 women underwent breast implant surgery for reconstruction after mastectomy.1 That’s a decrease from 2008, but the number of breast augmentations for women and teenagers is still nearly three times the 1997 rate of 101,176.2

The dramatic 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. There are no available statistics on how many women undergo their first breast implant surgery every year.

Debate swirls over the risks of breast implants, and physicians and patients are justifiably confused by the conflicting information available. An FDA announcement about the increased risk of a rare type of lymphoma in January 2011 again raises questions about safety. 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, only 35% of the patients were followed for at least three months, and there were only three 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 allowed silicone implants to remain available primarily to reconstruction patients and women who already had breast implants that they wanted replaced. Meanwhile, medical journals published articles questioning the health risks of breast implants.

Under the FDA’s compassionate need exemption policy, silicone gel implants were restricted in the U.S. to clinical trial participants, including a large “adjunct study” for reconstruction patients and women with broken implants (revision patients). Smaller numbers of first-time augmentation, reconstruction, and implant replacement patients participated in each company’s “core study.” It is important to note that the definition of reconstruction patients includes many women who are not mastectomy patients. Women can also be “reconstructed” to correct “deformities” such as very droopy breasts and “severe” asymmetry (both subjectively defined by the plastic surgeons). In addition, women who were unhappy with their saline breast implants were often able to find a physician who would enroll them in the adjunct study of silicone gel implants. 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 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. As a result of this very low follow-up rate, these “studies” did not provide meaningful safety data.

In October 2003, the FDA held an Advisory Panel meeting to consider approval of silicone breast implants made by Inamed. After considering the Advisory Panel recommendations and the scientific data, the FDA decided not to approve Inamed silicone breast implants in January 2004. At the same time that the decision was announced, 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 (also called McGhan or 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.

Meanwhile, in late 2005, the FDA Office of Criminal Investigation started an investigation of Mentor, interviewing former Mentor employees. This investigation focused on 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 investigation, in November 2006 the FDA approved silicone gel breast implants by Inamed (now Allergan) and Mentor as “reasonably safe” for women who are 22 or older. This was the first time that FDA had approved silicone gel implants, and because of serious concerns about safety, the FDA is requiring each of the two implant makers to study 40,000 women with breast implants for 10 years, recognizing that the 3-year studies were not sufficient to prove long-term safety. Unfortunately, unbiased long-term data are lacking. With few exceptions, the only published data regarding long-term safety are studies funded by implant companies, plastic surgeons, or Dow Corning.

Silicone or saline breast implants by companies other than Inamed and Mentor are not considered to be “reasonably safe” by the FDA. Several of those implants, such as those made by the French company PIP, were sold in other countries and later taken off the market because of a tendency to rupture sooner than other implants, and because the silicone apparently was not tested for health risks in humans because the manufacturer thought the silicone was being used for mattresses.5, 6

“Reasonably safe” does not mean safe for everyone. The FDA found that most implant patients have at least one serious complication within three years after getting silicone or saline implants.

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 cause 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 that “it is basically the same product it was 10 years ago—it is essentially the same product.7

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 recent years, 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 because of safety concerns.8, 9, 10, 11 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.

Frequency of Local Complications

Risks associated with surgery include infection, hematoma (blood or tissue fluid collecting around an implant), and the risks associated with anesthesia.

Pain and Capsular Contracture: All implants are “foreign bodies.” A woman’s body reacts to the introduction of this foreign object by forming a capsule of scar tissue around the implants. When this capsule becomes too tight for the implant—a common problem—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. 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.12, 13 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. 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.14 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 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, most women had at least one broken implant within 10 years, and the likelihood of rupture increased over time.15 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 found 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.13 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.16

Leakage: Numerous studies have shown silicone leakage 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.17, 18 Recent case studies have confirmed that silicone can migrate to the lymph nodes.19, 20 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 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. 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.21 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. That is much higher than the 33% obscured in women without implants in the same study.22 Mammograms also tend to be less accurate if the woman has capsular contracture. In addition, women with implants may be reluctant to undergo mammograms because of fear of rupture, and a study by FDA scientists indicates that silicone or saline implants sometimes rupture when women undergo mammograms.23 The alternative, undergoing a regular breast coil MRI to check for cancer, is prohibitively expensive for many women at $2,000 each time and needs to be read by an expert. 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.23

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.24 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.25 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.

Autoimmune and Connective Tissue Diseases

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. Studies from the 1990s tended to show no increase in risk, but more recent studies suggest that there is an increased risk of these diseases.

A study conducted by FDA scientists found a statistically significant link between implants and fibromyalgia, as well as several connective tissue diseases.26 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.27 In contrast, rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed.

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.28 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.14 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 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.24, 29, 30

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.31, 32 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.33

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.

Cancer, Lymphoma, and Lung Disease

Implant manufacturers claim 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 15-20 years of follow-up would be necessary to conduct a well-designed study of cancer after exposure, whether to asbestos, tobacco, or breast implants. Most of the implant studies were 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.

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.34 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.35 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.36, 37

In January 2011, the FDA announced that women with breast implants seem to be more likely to have 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 not enough evidence to suggest that ALCL is more likely in a particular implant type, or to determine its cause in women with implants.38 As a result of this concern, the FDA is now requesting that providers report cases of ALCL in women with breast implants, to determine how great the risk is compared to women without implants.

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.36, 37, 39 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 augmenation patients to other women plastic surgery patients of the same age, race, and education.34 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.40

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 Surgeons41 and by Dow Corning42 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.34 Similarly, the most important demographic predictors of suicide, which are age, race, and sex, were already controlled in the Scandanavian studies finding an increased risk of suicide.36, 37, 39

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.43 However, Danish women needed a psychiatric referral in order to qualify for free augmentation surgery, which could easily explain this small, non-significant difference.44

It is also important to note that a recent Danish study found an increase in depression among women who had undergone breast augmentation.13 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.34

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.45

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.40 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.46

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.43 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.47 Self-selection makes it difficult to interpret these data, but the Inamed 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. Overall, these findings indicate that implant companies have yet to prove that implants objectively improve women’s quality of life.48

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 warrantee 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.

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.49 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.”50, 51 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 articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

References:

1 ASPS 2010 Report of the 2009 Statistics, p. 6. American Society of Plastic Surgeons (ASPS), 2010. Available: http://www.plasticsurgery.org/Documents/Media/statistics/2009-US-cosmeticreconstructiveplasticsurgeryminimally-invasive-statistics.pdf.

2 ASAPS 1997 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), Inc., 1998. Available: http://www.surgery.org/sites/default/files/ASAPS1997Stats_0.pdf.

3 The FDA’s Regulation of Silicone Breast Implants: A Staff Report Prepared by the Human Resources and Intergovernmental Relations Subcommittee of the House Government Operations Committee, December 1992. Available: http://implantawareness.com/PDF/FDAReg1.pdf.

4 Harris G, “Implant Maker Hid Defects, Workers Said.” New York Times, May 22, 2005. Available: http://www.nytimes.com/2005/05/22/national/22implant.html?_r=1.

5 “L’afssaps lance l’alerte aux prothèses mammaires défecteuses.” AFP, March 31, 2010. Available: http://www.lemonde.fr/societe/article/2010/03/31/l-afssaps-lance-l-alerte-aux-protheses-mammaires-defectueuses_1326644_3224.html.

6 Macrae F & Randall C, “Thousands of British women in dangerous breast implants alert.” Daily Mail, June 18, 2010. Available: http://www.dailymail.co.uk/health/article-1287564/Thousands-British-women-dangerous-breast-implants-alert.html.

7 General and Plastic Surgery Devices Panel Transcript, 2003. 14 October 2003; 231. Available: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.htm.

8 Device Alert – Breast Implants: NovaGold. United Kingdom: Medical and Health Care products Regulatory Agency. Available: http://www.mhra.gov.uk/index.htm.

9 Medicines and Health Care products Regulatory Agency. Available: http://www.mhra.gov.uk/index.htm.

10 Laurance J, “Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer.” The Independent, 7 June 2000.

11 Device Alert: Trilucent (soya bean oil filled) breast implants. United Kingdom: Medical and Health Care products Regulatory Agency. Available: http://www.mhra.gov.uk/index.htm.

12 Nagelin-Anderson, E & Zuckerman, D. Complications of Saline Breast Implants: What You Should Know Before You Decide on Augmentation. Available: http://www.breastimplantinfo.org/recon/ibrief-aug042003.html.

13 Zuckerman D, Santoro E, Hudak N. Silicone Breast Implants: Illnesses and Complications, The Latest Research from Inamed’s Core Study. National Research Center for Women & Families. Washington: DC; 2003. Available: http://www.breastimplantinfo.org/what_know/oct03_summary.html

14 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.

15 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. American Journal of Roentgenology. 2000; 175: 1057-1064.

16 Holmich L, Friis S, Fryzek J, et al. Incidence of silicone breast implant rupture. Archives of Surgery. 2003; 138: 801-6.

17 Beekman WH, Feitz R, van Diest PJ, and Hage JJ. Migration of silicone through the fibrous capsules of mammary prostheses. Annals Plastic Surgery. 1997; 38: 441-445.

18 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).

19 Adams ST, Cox J, GS Rao. Axillary silicone lymphadenopathy presenting with a lump and altered sensation in the breast: a case report. Journal of Medical Case Reports. 2009; 3: 6442.

20 Dragoumis DM, Assimaki AS, Vrizas TI, Tsiftsoglou AP. Axillary silicone lymphadenopathy secondary to augmentation mammaplasty. Indiana Journal of Plastic Surgery. 2001 Jul-Dec; 43(2): 206-209.

21 James SE, Tarr G, Butterworth MS, et al. Silicone in the sputum after rupture of a calf implant. Journal of the Royal Society of Medicine. 2001; 94:133-134.

22 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.

23 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.

24 Bondurant S, Ernster V, Herdman, R, eds. Safety of silicone breast implants. Washington, DC: Institute of Medicine; 1999.

25 “Platinum found in women with implants.” The Associated Press, 26 August 2004; and Maharaj, SVM. Platinum and platinum species in explanted silicone gel breast prosthetic devices using IC-ICP-MS. Presented at the American Chemical Society, 22-26 August 2004.

26 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.

27 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.

28 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.

29 Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction. Summary of Report of National Science Panel. Available: http://www.fjc.gov/BREIMLIT/SCIENCE/summary.htm.

30 Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective tissue diseases. New England Journal of Medicine. 2000; 342:781-790.

31 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.

32 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.

33 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.

34 Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: An update. Epidemiology. 2006; 17: 162-9.

35 Brinton, LA, Lubin JH, Burich MC, et al. Cancer risk at sites other than the breast following augmentation mammoplasty. Annals of Epidemiology. 2001; 11: 248-256f.

36 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.

37 Jacobsen PH, Holmich LR, McLaughlin JK Mortality and suicide among Danish women with cosmetic breast implants. Archives of Internal Medicine. 2004; 164: 2450.

38 Food and Drug Administration. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses. Available: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm.

39 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.

40 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.

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

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

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

44 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.

45 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.

46 Brinton LA. Do breast implants after a mastectomy affect subsequent prognosis and survival? Breast Cancer Research. 2005; 7: 61-63.

47 Rowland JH, Desmond KA, Meyerowitz BE. Role of breast reconstructive surgery in physical and emotional outcomes among breast cancer survivors. Journal of the National Cancer Institute. 2000; 92: 1422-29.

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

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

50 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.

51 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.

Medicare Breast Implant Removal Policies by State


Click on your state (or territory) below to see it’s official Medicare policy on breast implant removal.

If your state/territory isn’t listed, it doesn’t have its own policy. You can look at this policy, which is usually borrowed by states that don’t have their own policy.  

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Beatrice R.


California

I am Beatrice R. I had hoped to be there in person, but my flight was canceled due to the hurricane. Thank you for showing this video instead.

I am currently a single mother, a photographer, and a multimedia consultant. I speak four languages and I was raised in Europe. I live in San Diego.

In 2005, I wanted a minor nipple procedure, to correct a cosmetic problem caused by breastfeeding. Two surgeons advised implants. Dr. Minniti in Beverly Hills convinced me that the implants were safe and that once they were in, I would never have to worry about them for the rest of my life, unless of course I had a capsule, and in that case he’d break it, a minor office visit.

The study documentation was presented to me for signing for the first time at the pre-op. appointment. I had no time to read the over a dozen pages, but I was reassured that all women were part of the trial and it was a mere formality. This is the Adjunct study referred to by the FDA.

Please note that no one ever followed up at any time, despite my sending many emails regarding my ailments to both FDA and Mentor.

Because I am the athletic type, I chose small implants. Without my consent, the surgeon implanted me with the whopping 450cc, about twice the size I wanted. I was a teacher and felt ridiculous and deformed after the surgery. I stopped going to the gym because even with two sports bras I could no longer run and men were obsessing with my chest size. My chest muscles were deformed because they were cut deeply to adjust to these enormous implants. I can never do any sports that put strain on my chest, which is most sports.

This is a point I’d love the FDA to pay attention to, as surgeons may use implants that are not the ones agreed on, but these details are not in writing.

The larger implant size was a problem, but not as big as a problem as the severe immune reaction I had to the implants.

Within days after the surgery, the skin on my arms and forearms felt very sore and sensitive, and a strange pain seemed to come and go at different locations in my body. Ankles and knuckles were the worst. The pain would take my breath away, and never stopped, day or night. The pain killers, anti inflammatory and muscle relaxant, prescriptions, nothing helped.

Nights were exhausting, trying to get comfortable and get more than 3 hours of sleep at a time. I had to lay down in bed either on my back or sideways and having to rotate continuously because the arms would go numb. After only a few hours of sleep I’d be awake and pacing around at home.

I had a burning sensation on my upper lip at all times. My eyes were dry in the morning and feeling like sand and very painful. Some days one eye would go completely blurry and a few hours later it seems like I had perfect vision. My hair started to fall off and I gained 15 pounds in just a few months.

I saw many specialists, who ran every possible test. One year after getting the implants I had a sinus infection that developed into bronchitis and lasted for months. I did three rounds of antibiotics and developed staph on my neck, which triggered an asthma attack and sent me to the emergency room. This is all documented with my doctors. The school wanted to fire me because I kept missing work.

One day the pain in my left ring finger was so strong that I had to go to the emergency room to get X-rays. They couldn’t figure out what was wrong. At times, pain would shoot in my right foot, and this was very dangerous while I was driving.

At times the gums in my mouth were pulsating at the root of my teeth. It felt like removing teeth would be relief. My labia were painful, my feet arches would get stiff and I’d feel a throbbing pain at the joints. Then the symptoms got worse. My vertebrae started to make loud popping noise upon waking up.

My immune system was completely out of control but none of the doctors could figure out what to do to help me. Then the brain. Driving home from L.A. one night, I no longer knew if I was in Italy, in France, or in the United States. This was incredibly scary, I was losing my mind. Everything was getting worse. Soon, I had to systematically walk up and down every row of cars in a parking lot to find where I had parked.

Over the next 20 months, I visited 12 specialists and met with three surgeons to discuss getting my implants removed. Waking up in the morning, I would look at my front door and feel completely overwhelmed, in tears, by everything I needed to do to get ready for work — simple steps as showering and getting dressed, brushing my hair, my teeth, and out into the world. This was like climbing the Kilimanjaro.

I felt like a woman in her 80s, at the end of her life. A vaginal ultrasound revealed I had three ovarian cysts, two fybroids and a mass that had to be operated right away. So now I had to postpone getting my implants removed until that surgery was completed.

Fearing the worse, I made a video on Youtube telling my unfortunate guinea pig experience, for other women to find support and stay away from the damaging silicone. To my surprise dozens and dozens of women responded to my video. Women from all over the country and the world told me of the exhausting suffering, health deterioration and complications, lack of funds to see doctors and run tests, and the frustration of their families not being able to help them.

I am angry that the FDA allowed these potentially dangerous implants on the market, with studies that were not really aimed at collecting scientific evidence of safety. The silicone gel includes heavy metals and potentially dangerous chemicals, and each label should include all the ingredients, just like with the food industry. The FDA should also require that the labels should also include examples of the patient’s potential expenses for lab testing, the loss of time from work, and harm to one’s quality of life.

At today’s meeting you are supposed to decide what research needs to be done. The FDA has stated that serious health problems are rare with breast implants, but I can tell you that is not true. Based on my experiences, neither the plastic surgeons nor the implant companies can be trusted to do this research objectively. Certainly, neither reported my serious health problems to the FDA.

Beatrice submitted her story to be read at the FDA Advisory Committee Meeting on breast implants in August 2011.