Category Archives: Problems With Implants

Are “Gummy Bear” Breast Implants the Safer Implants?

Diana Zuckerman, PhD, Madris Tomes, and Amelia Murphy, National Center for Health Research and Device Events

Based on the summary of book chapter in Breast Implants, Rene Simon (ed.), Nova Science Publishers, 2017.

Our new book chapter on breast implants explains that the 55-year history of breast implants reflects repeated efforts to improve their safety and effectiveness by reducing the cosmetic problems and health complications that develop during the years while they are in the human body. The most recent effort is the type of highly cohesive breast implants known as “gummy bear implants” because of the thick gel that is described as similar to gummy bear candies. The goal of the more cohesive gel is to make implants last longer and be less likely to leak. First approved in the United States in 2012, adverse event reports indicate that this newest generation of implants causes complications similar to older generations of silicone gel breast implants.

The first breast implants, made in the 1960’s, were for cosmetic enhancement. When women’s augmented breasts became hard over time, implant manufacturers responded by making the silicone gel thinner. One manufacturer, Surgitek, added polyurethane foam to the outside to make the breasts feel softer. Those design changes caused other problems, however: the thinner gel had a tendency to “bleed” through the silicone elastomer shell, which contributed to the most common complication, capsular contracture. Breast implants made with thinner gel also ruptured and leaked more easily, and the gel broke down into silicone oil which could migrate to other organs or cause silicone granulomas inside their bodies. The polyurethane foam caused other problems: implant removal was very difficult and women lost their breast tissue during explant surgery, and the foam was found to break down to a known carcinogen.

The Food and Drug Administration (FDA) did not require breast implant manufacturers to submit data to prove the implants were safe and effective until 1992. By that time, the manufacturers had developed implants with a thicker shell and a more cohesive silicone gel. However, the studies revealed that, like the earlier implants, the more cohesive implants did not “last a lifetime” as had been claimed. As a result, manufacturers continued to modify the silicone gel to make it less likely to rupture and leak.

Despite claims that gummy bear implants are safer than other breast implants, a 5-year study found that the rupture rate was more than 4% for first-time augmentation patients.  The percentage of women needing additional surgery within 5 years ranged from 17% to 48%, depending on whether the patients were augmentation patients or reconstruction patients, and whether the gummy bear implants replaced previous implants. Our analysis found that from January 1, 2008 through June 30, 2017, 1298 adverse event reports for silicone gel breast implants were made to the FDA, 252 (19%) of which were for gummy bear implants. This is very high when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to FDA approval in 2012. This chapter puts these statistics in the context of what is known about the safety of silicone breast implants and how that has changed over time.

Copies of the entire book chapter are available upon request at info@center4research.org

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

by Maura Duffy and Diana Zuckerman, PhD

Experts now agree that breast implants can cause a type of cancer of the immune system. The Food and Drug Administration (FDA) finally admitted this risk of cancer in 20171, but other experts – including plastic surgeons – were aware of the risk years before. Why did it take so long for the FDA, the media, and women with implants to find out that choosing breast implants could increase their chances of developing a potentially fatal disease?

Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that was estimated to affect 1 in half a million women.2 It usually develops in the lymph nodes, skin, lungs, or liver. However, ALCL sometimes develops in the breast area of women with breast implants.

In 2008, Dutch researchers published a report of 11 women with breast implants and ALCL, and concluded that the implants seemed to be associated with ALCL.3 Although published in the Journal of the American Medical Association (JAMA), this information was not widely reported.

The link between ALCL and breast implants was first reported by the FDA in January of 2011. In 2013, researchers at MD Anderson Cancer Center studied 60 women with breast implants who were diagnosed with ALCL in the breast. Since ALCL was thought to be diagnosed in only 1 woman in half a million, this was much higher than would be expected.4 In 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit network of cancer experts, released a worldwide oncology standard for surgeons and oncologists to test for and diagnose “breast implant associated ALCL (BIA-ALCL). In 2016, the World Health Organization (WHO) officially recognized BIA-ALCL.5

And yet, it was not until March 2017 that the FDA finally updated its website to officially report that breast implants could cause ALCL. At the time of the FDA announcement, the agency reported that they had received 359 reports of ALCL among women with breast implants. Reports to the FDA of problems from medical devices are acknowledged to be the “tip of the iceberg” since surgeons frequently do not do these online reports.

How did the women find out they had ALCL before the official announcement of BIA-ALCL was made? Most of them approached their doctors with symptoms such as pain, lumps, swelling, or asymmetry in their breasts years after getting implants. Since breast implants are a “foreign body,” the body forms scar tissue around the implant to protect their body from this “foreign invader.” The scar tissue surrounding the implant is known as the scar capsule. It is natural for the body to form scar tissue, and the scar tissue is only a problem if it tightens or hardens around the implants, causing pain and hardness known as “capsular contracture.” Breast implant-associated ALCL is almost always found in the scar capsule surrounding the implant, not the breast tissue itself, and has been reported in women both with and without capsular contracture.6

ALCL is diagnosed by testing the fluid that collects around the implant, called a seroma.7 Seroma is usually not caused by ALCL. It is important to understand that even when ALCL is in the breast, it is not breast cancer, but rather a cancer of the immune system.  Most breast implant-associated ALCL has cancer cells within the fluid inside the scar capsule. That ALCL can be treated by removing the implant and the surrounding scar tissue. This surgery is known as a capsulectomy.

One study of nine women who had a capsulectomy after being diagnosed with breast implant-associated ALCL found that all nine were healthy and disease free when they were studied 3.5 years later, and neither chemotherapy nor radiation treatment was necessary. However, some types of ALCL are more aggressive and need to be treated with chemotherapy or radiation. 8

In December 2013, the study of 60 patients with breast implant-associated ALCL showed that the ALCL was more likely to be fatal for women who had a solid ALCL tumor than for women who had ALCL cancer cells in the surrounding fluid (known as effusion ALCL). All of the patients with effusion-type ALCL were still alive 5 years after their diagnosis, compared to only 75% of the patients with solid ALCL tumors. ALCL returned in only 14% of patients with effusion-type ALCL, compared to 50% recurrence of solid ALCL tumors.9

Longer studies with more patients are needed to determine if some kinds of breast implants are more likely to cause ALCL. Meanwhile, women with all types of implants should have routine follow-ups and should immediately see a doctor if one or both of their breasts become swollen.

For women with silicone implants, FDA recommends getting a breast coil MRI three years after getting silicone gel implants, and every two years after that.10

A statement on ALCL from Allergan, a manufacturer of both silicone and saline breast implants, said, “A woman is more likely to be struck by lightning than to get this condition.”11 However, 400 people are injured or killed by lightning every year12, which is why most people avoid situations where lightening can harm them.

In fact, the Australian version of the FDA now estimates that up to 1 in 1,000 women with breast implants will develop BIA-ALCL which is not nearly as rare as plastic surgeons and manufacturers have claimed. 13

Many women would not want to take the chance of developing cancer as a result of breast implants, and this is especially true for women who underwent mastectomies that were not medically necessary in an effort to reduce their chances of cancer returning.

In addition, the link between breast implants and autoimmune diseases has been hotly debated for two decades, with many women reporting serious autoimmune symptoms that went away when their implants were removed 14. The scientific evidence regarding ALCL and implants once again raises questions about the possible impact of breast implants on autoimmune disease or symptoms such as joint pain, body pain, memory loss, and chronic fatigue.

For many years, women with breast implants were assured by implant companies, plastic surgeons, and the FDA that breast implants did not cause breast cancer or any other type of cancer. Evidence of a link to some types of cancer and to autoimmune diseases, including studies conducted by researchers at FDA and the National Cancer Institute, was dismissed. However, as everyone knows from data on lung cancer, emphysema, and smoking, it can take decades to determine if an exposure causes cancer or other serious diseases. Even a very strong carcinogen, such as tobacco, is very unlikely to cause lung cancer for at least 30 years. For this reason, it is essential that physicians and researchers take a closer look at the link between breast implants and cancer of the immune system, as well as other immune disorders.

Breast implants after mastectomy: Risks you need to know

Diana Zuckerman, Ph.D.
Updated 2017

The complication rate for getting breast implants after mastectomy has been described by experts as “alarmingly high and arguably unacceptable,”15 even though most of the information about complications is based on studies that were paid for by companies that make breast implants or silicone.

How safe are breast implants and how many women have complications after getting reconstruction with breast implants after a mastectomy? When the Food and Drug Administration (FDA) approved breast implants, they acknowledged that the complication rate is very high for all women, especially those undergoing reconstruction after a mastectomy. What the FDA did not know, however, is that early-stage breast cancer patients that undergo mastectomy and reconstruction with breast implants are 10 times as likely to commit suicide as other early-stage breast cancer mastectomy patients.

Complications from Implants

We do not know why the suicide rate is so high for mastectomy patients with breast implants, but we do know that complications are very common. For example, a study conducted by implant manufacturer Inamed (now called Allergan) found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants 16. Not surprisingly, the implant maker did not publish an article describing this high complication rate, which was more than twice as high as the 21% reported in a study funded by a company that makes silicone (Dow Corning).1

Why was the complication rate lower in the Dow Corning study? One explanation is that the women in that study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Even so, the Dow study found that 31% of the women developed at least one serious complication and 16% developed at least 2 serious complications in that short period of time. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture (which is painful breast hardness), 6% experienced necrosis (death of breast tissue), 6% had other types of breast pain, and 6% had an implant that ruptured, and other women reported infections and other complications.2  This shows that both studies found very high complication rates despite a short follow-up of less than 3 years.

The Dow-funded study concluded that “reconstruction failure (loss of implant) is rare.” Of course, it should be rare after less than 2 years. In contrast, when Inamed used Magnetic Resonance Imaging (MRIs) to detect rupture, they found that 20% of reconstruction patients had ruptured implants by the third year;17 but very few ruptures were detected without MRIs. Since Henriksen did not use MRIs. Since the Dow Corning study did not use MRIs to detect rupture, they couldn’t accurately count the number of failed implants.  Moreover, FDA scientists concluded that the risk of rupture would likely increase exponentially every year.18

Many plastic surgeons claim that the Institute of Medicine concludes that breast implants are safe. However, the Institute of Medicine report was completed in 1999, years before most research was conducted. Most research on breast implant patients was published after 1999, making the report very outdated. Many of the studies reported higher levels of diseases or symptoms among women with breast implants, which would have reached statistical significance if the studies were larger and women were followed for a longer period of time.

Can implants cause cancer or other serious diseases?

Experts around the world now agree that breast implants can cause a type of cancer of the immune system called ALCL (anaplastic large cell lymphoma).  In fact, there is now a specific diagnosis called breast implant associated ALCL (BIA-ALCL).  If caught early, removal of the breast implants can be very effective, but if not treated quickly it can be fatal. 19

The link between breast implants and other cancers remains controversial.  Studies paid for by plastic surgeons or implant companies tend to conclude that breast implants are safe. Since breast implants can cause cancer of the immune system, it seems logical that implants might have an impact on other diseases of the immune system or other cancers.  For example, FDA scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared to women with silicone implants that were not leaking outside the scar tissue capsule.4 In addition, scientists at the National Cancer Institute (NCI) found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared to other plastic surgery patients.20 National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases.5,6

The Bottom Line

Many women choose mastectomies to “get rid of the cancer once and for all” hoping that it is the safest strategy for dealing with breast cancer.  However, research shows that women who have lumpectomies live longer than women with the same diagnoses that chose mastectomies instead. Research makes it clear that there are many complications from breast implants that often keep women needing additional surgery and medical help in the years after breast cancer is removed, including the possibility of cancer of the immune system.  Unfortunately, many women tell us that their doctors did not warn them about these risks. [Read a New York Times article about a woman with ALCL here.]

Some of the information from this article was based on Dr. Zuckerman’s article published in Archives of Surgery, Vol 141, pages 714-715. The original article can be found here.

How Obamacare can help women with breast implant problems!

For years we have heard from women with leaking breast implants and other serious implant problems who want to get their implants removed but can’t afford it.  Breast cancer patients who have health insurance have been covered but augmentation patients have not.  And, breast cancer patients who couldn’t afford health insurance (and there are many) were also out of luck.  Many women who have been in this situation or might be in the future will find that Obamacare is a great help! We encourage women to take advantage of the law while it is still in place, because it might be repealed or substantially changed in the future.

  • Under Obamacare, health insurance companies can’t refuse to pay for health problems related to a pre-existing condition.  Before Obamacare (the Affordable Care Act), many insurance companies considered breast implants a pre-existing condition.  Under Obamacare, insurance companies are generally required to pay for services that are medically necessary, even if the reason for the health problem is a pre-existing condition.  However, some insurance companies may try to exclude any services related to complications from cosmetic surgery, so read the policies carefully before you choose.
    • California, Florida, Massachusetts, New York, North Carolina, Texas, and Washington tend to be especially good about coverage for medically necessary services, even those related to previous cosmetic surgery. Medically necessary services usually include removal of leaking silicone gel breast implants, as well as removal of implants causing severe capsular contracture, serious infections, chronic pain, ALCL (a rare cancer of the immune system), or other serious health problems that a doctor says are caused by implants.
  • The State Insurance Exchanges offer health insurance policies that will be better and more affordable than most policies available to individuals who aren’t insured through their workplace.  It is important to go to www.healthcare.gov and look into the plans offered on your state’s Exchange. If you have lost an existing health insurance policy because of a change in marital status or job or other reasons, you can sign up for the exchange now – otherwise, the only time to sign up is between November 1 and December 15, you can get coverage starting January 1, 2018.  You will find pricing information for 2018 on the website. The lower your income, the less you will have to pay for these health insurance policies.  Check out the choices you have in your state on www.healthcare.gov and sign up as soon as you decide and definitely before Dec. 15, 2017 if you want to start your health insurance on January 1.  And make your appointment now for January surgery, if you need it!
  • To make sure that the policy you plan to buy includes implant removal or other coverage for the kind of implant problems you have, ask that question BEFORE you buy the policy.  If they can’t answer your question or tell you it would not be covered, please contact us immediately at info@center4research.org.  We will do our best to help.
  • In many states, Medicaid is available for free to any individual or family under 133% of the poverty line (that’s about $30,000/year for a family of 4).  Medicaid must provide coverage for pre-existing conditions and so it should include surgery or services that a doctor considers medically necessary, such as removing leaking silicone gel breast implants, implants causing chronic pain or infections, and other serious health problems.   If you are on Medicaid or Medicare and have problems getting this coverage, please contact us immediately at info@center4research.org .

 

ALCL and Breast Implants: 2017 Update

By Anna E. Mazzucco, Ph.D and Diana Zuckerman, Ph.D
Updated: March 24, 2017

In March, 2017, the U.S. Food and Drug Administration (FDA) updated its website to officially report that breast implants could cause a type of cancer of the immune system called anaplastic large cell lymphoma (ALCL).  They stated they have received 359 reports of ALCL among women with breast implants.

The FDA’s announcement came 10 months after the disease was named breast implant associated ALCL (BIA-ALCL) in a  World Health Organization publication in 2016, and a few months after the National Comprehensive Cancer Network (NCCN) released the first worldwide oncology standard for the disease.  NCCN includes a guided algorithm for surgeons and oncologists to test for and diagnose the disease.  They concluded that any abnormal accumulation of fluid or a mass that develops near the breasts months after breast implants were implanted must be evaluated.

The oncologists also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years.  Here is the link to their guidelines: https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf#page17

Although rare, it seems that BIA-ALCL is not “very rare.”  In Australia, which can track medical problems from any kind of implants better than the tracking of implants in the U.S., they estimate that BIA-ALCL affects one woman per 1,000 with breast implants.  The estimates were much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S.  Given the dramatic increase in diagnoses, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.

The sooner ALCL is diagnosed, the more likely it can be treated easily and effectively by removing the implants and capsule.  At later stages, treatment includes chemo and is less likely to be successful, as specified by researchers at the well-respected MD Anderson Cancer Center in a medical journal in 2013. Their study followed women for 5 years and found that ALCL related to breast implants sometimes requires chemotherapy, and approximately 25% of the implant patients with the more serious type of ALCL died during the 5 years following their diagnosis.[1] Dr. Anna Mazzucco published a response to this study,[2] urging physicians to respond quickly and to check patients who have swelling near their implants for ALCL. This would require cytology testing rather than testing for bacteria. The authors of the original study also published a response to Dr. Mazzucco’s article, expressing similar concerns.[3]

For more information, see our summary of that study here.

ALCL caused by breast implants can result in swelling, which is often mistaken for an infection and treated with antibiotics. Antibiotics are ineffective against ALCL and the delay in timely and appropriate treatment for ALCL is dangerous.

Unfortunately, some health insurance companies have traditionally not covered the cost of medical tests or treatment for women with breast problems related to cosmetic breast implants. The published articles on ALCL clearly indicate that this can result in undetected cancer of the immune system (ALCL), which can be fatal. In addition, delays in treatment for ALCL can be extremely expensive for patients and their insurance companies; the companies would be required to pay for treatment for ALCL when it is eventually diagnosed at a later stage.

  1. Miranda RN, Aladily TN, Prince HM, et al: Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol 32:114-120, 2014.
  2. Mazzucco, AE. Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014.
  3. Miranda RN. Reply to AE Mazzucco. J Clin Oncol, 2014. Early Release publication. June 16, 2014.

 

 

Cancer of the Immune System (ALCL) and Breast Implants: Plastic Surgeons Study 173 Women

Diana Zuckerman, PhD, National Center for Health Research

In 2015, plastic surgeons who have been well known for defending the safety of breast implants published a study of 173 women with cancer of the immune system caused by breast implants. [1] The study was paid for by a plastic surgery medical association and written by plastic surgeons who have defended the safety of breast implants for decades.

ALCL (Anaplastic Large Cell Lymphoma) develops near a breast implant but is not breast cancer – it is a cancer of the immune system. The authors of this study point out that the first silicone breast implant was implanted in 1962 and the first publicly reported case of ALCL in a woman with silicone breast implants was in 1997. The authors reviewed 37 medical articles reporting on 79 patients and collected information about an additional 94 women with ALCL caused by breast implants.

Results

Physicians first identified these 173 women with ALCL based on either seromas (a collection of fluid under the skin), a mass attached to the scar capsule surrounding the implant, a tumor that eroded through the skin, in a lymph node near the breast, or discovered during surgery to replace a breast implant. Whether the women had silicone gel or saline breast implants didn’t seem to make a difference, but many of the women had at least one textured breast implant.  Cosmetic augmentation patients and women who had breast implants to reconstruct their breasts after undergoing a mastectomy were both at risk of developing ALCL because of their implants. Of the women whose ALCL spread outside of their scar capsule surrounding the implant, about half died from ALCL.

The authors pointed out that ALCL can be difficult to diagnose. Although the fluid and scar capsule usually appear abnormal, they sometimes look normal. The authors recommend “that all fluid and capsule tissue from patients with seromas” should be tested for ALCL. They point out that if the tumor is inside the capsule, removing both implants and the capsules may be the only treatment necessary. However, if the tumor has developed just outside the capsule, chemotherapy with or without radiation is needed and usually effective. Unfortunately, aggressive ALCL that has spread beyond the scar capsule area is usually fatal, regardless of treatment.

[1] Brody GSDeapen DTaylor CRPinter-Brown LHouse-Lightner SRAndersen JSCarlson GLechner MGEpstein AL. Anaplastic Large Cell Lymphoma Occurring in Women with Breast Implants: Analysis of 173 Cases. Plastic and Reconstructive Surgery. Vol 135: 695, 2015.

The official summary of the above citation is here: http://www.ncbi.nlm.nih.gov/pubmed/25490535

To read about another study on ALCL, click here.

To read more about what you need to know about ALCL, click here.

2017 Update

In March 2017, the U.S. Food and Drug Administration (FDA) reported that it had received 359 reports of ALCL among women with breast implants. Unfortunately, many cases of ALCL are not reported to the FDA.  The FDA’s announcement came after the World Health Organization (WHO) officially recognized “breast implant associated ALCL (BIA-ALCL)” in 2016. In 2014, the National Comprehensive Cancer Network (NCCN) has also released a worldwide oncology standard for surgeons and oncologists to test for and diagnose the disease.

Sientra’s Silimed Brand “Gummy Bear” Silicone Gel Breast Implants Pose Safety Questions

gummy-bear-bubblegumMingxin Chen, MHS and Diana Zuckerman, PhD, The National Center for Health Research

In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s for its “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.

To gain approval, the company was required to submit the results of a clinical trial to prove that the implants were safe and effective. A 5-year study of these implants was published in the November 2012 issue of Plastic and Reconstructive Surgery, authored by three Sientra employees and several plastic surgeons who were paid by Sientra to conduct the research.21 The study included 1,788 participants with 3,506 breast implants.

Re-operation, Rupture, and Capsular Contracture

The three major complications measured were need for a re-operation, rupture, and capsular contracture. They can occur at any time, and become more common as the implants age. Capsular contracture refers to the formation of scar tissues around breast implants which becomes hard and potentially painful as the patients’ immune system reacts to the implant. MRIs were conducted on 571 of the 1788 participants to assess rupture that has no obvious symptoms.

The study indicated that the overall risk of rupture during the five years of the study was 2%, but that is misleading because the rupture rate was higher when “silent ruptures” measured by MRI were counted. MRI is the most accurate way to determine if an implant is ruptured, and more than 4% of first-time augmentation patients had a rupture within 5 years, which is much higher than expected. The risk of capsular contracture was 9% overall, and did not vary much for the different types of patients.

In contrast, the risk of reoperation varied considerably: 43% for first time reconstruction patients, 48% for reconstruction revision patients, compared to 17% for first time augmentation patients and 30% for augmentation revision patients. Revision patients are those whose previous implants were replaced with the Sientra implants.

Other Complications

There were many other complications affecting appearance and health. Most complications are highest for patients whose implants are for reconstruction after mastectomy; for example, 11% have asymmetry, 5% have an infection; 4% have breast pain, 4% of the implants are not in the correct position, and 3% have abnormal scarring. Complications are even higher for reconstruction patients who had earlier implants replaced by Sientra implants: 15% have breast asymmetry, 7% have implants in the wrong place, 5% have breast lumps or cysts, and 4% have breast pain.

For first-time augmentation patients, 3% have nipple sensation changes (either losing sensation or painfully sensitive) and 3% have sagging breasts. As noted earlier, reoperation, capsular contracture, and rupture are more common. Other complications, such as pain and swelling, add up, but each of these others complication is below 3%. Among revision augmentation patients, 5% have implants in the wrong position, 3% develop sagging breasts, 3% have wrinkling around the implant, and 3% have breasts that look asymmetrical.

Despite these high level of complications within only five years was high, the authors defended the implants. For example, they stated that over half of the patients who removed or replaced their implants did so for cosmetic reasons, predominantly patient request for style/size change. Regardless of the reason however, additional surgery is expensive and puts the patient at risk. And for breast cancer patients who chose mastectomy and implants so they would not have to think about cancer, these surgeries are a very unwelcome reminder.

The authors claimed Silimed is superior to the other two implant brands, Allergan and Mentor, in terms of risk of complications, as its risk of capsular contracture among first-time and revision augmentation patients within 5 years is 9% and 8%, in comparison with Allergan’s 13% and 17%, and Mentor’s 9% and 20%, both within 4 years.

Sientra, based in Santa Barbara, California, is the third largest global manufacturer of silicone implantable devices. The approval of the first gummy bear implants was welcomed by plastic surgeons, who pointed out that these implants had been manufactured and distributed outside of North America for 15 years.  However, the FDA approved the implants based on only 3 years of data, rather than the longer studies that would have been possible since the implants were on the market for 15 years.

Why are celebrities removing their breast implants?

Amelia Murphy

Celebrities who removed their breast implants

Every now and then, a new celebrity is in the news after announcing her decision to remove her breast implants. They speak out about the importance of loving yourself the way you are, they post some Instagram pictures of “the new me,” and the public eagerly reads the related articles in tabloid magazines.

But most of these women aren’t just talking about body image; they are getting their implants removed because of their health. Breast implants can make some women so sick that removal is their best hope for feeling like themselves again.  Several celebrities are trying to spread this information to the general public.

crystal_hefner_2014Crystal Hefner, Hugh Hefner’s wife, opened up about her breast implant horror story on Facebook. She announced her implants had been slowly poisoning her and causing unexplained back pain, cognitive problems, constant neck and shoulder pain, recurring infections, and many other symptoms. Once she removed her breast implants, she instantly felt an improvement and continues to feel better. [Read more about her story in this Forbes article]

Yolanda Foster, of Real Housewives fame, removed her breast implants when she found out her silicone implants had ruptured and were leaking into her body. The silicone was making the symptoms of her Lyme disease even worse. She felt much better once she removed her implants.

Linda Blair, actress in the horror movie The Exorcist, described her experience with breast implants as a nightmare. After removing her implants, she advocated for the FDA to make sure breast implants are actually studied to be safe.

Mary McDonough, a child star in The Waltons who appeared as an adult in shows such as ER and Will and Grace, attributes her autoimmune disease (lupus) to her breast implants. She was healthy before getting implants, and it was only after her implants were removed that she immediately started to feel better. She has been one of the most outspoken celebrities on the risks of breast implants.

Karen McDougal is a former Playboy Playmate and current model who made the decision to have her implants removed after months of feeling sick. She has spoken out about the risks of breast implants in USA Today and People Magazine.

Mariel Hemingway, Sharon Osbourne, and Stevie Nicks are just a few of the other celebrities who chose to remove their breast implants because of serious health problems.

Celebrities are bringing attention to the health problems that thousands of women with implants have suffered from for decades.

First, a little history:

Women have been getting breast implants since the 1960’s, and although silicone gel implants were drastically restricted for many years during the mid-1990’s through 2005 because of safety concerns, the FDA approved them again in 2006 based on short-term studies done by breast implant manufacturers. FDA also required the manufacturers to do larger, longer-term studies after that, in order to make sure they were safe (these are called post-market studies).

These longer-term studies had a lot of problems, and most women did not stay in the studies long enough to provide useful scientific information.  However, studies have shown that the longer women have silicone breast implants, the more likely they are to experience problems with them.  FDA reported that the studies found that as many as 1 out of every 5 women who get silicone breast implants for cosmetic reasons need to remove their implants within 10 years.[1] This number rises to 1 out of every 2 women if they got reconstruction after a mastectomy.[1]  Were the women who dropped out of the studies the ones that were more likely to have health problems, or less likely?  You can read more about the unanswered questions from these studies here.

Breast implants were approved by the FDA even though research showed that between 15% and 20% of first-time augmentation patients will need additional surgery to fix implant problems within 3 years, whether the implants are filled with silicone gel or saline. [2][3] The chances of needing additional surgery increases as time goes on — 28% of women are on the second set of implants after 3 years, and this number doubles when the women have their implants for 6 years. The percentage is even higher than that for mastectomy patients whose implants were for reconstruction.

Are Your Breast Implants Making You Sick- (2)What usually goes wrong?

  • Rupture: All breast implants will eventually break, sometimes within a few months or years, and usually within 10 years.
  • Capsular Contracture: This is when the breasts get firm, then hard, and they can be very painful. Breast implants are a “foreign body” and the natural response for most women is that their body forms scar tissue around the implant, inside their body, to protect their body from this “foreign invader.”  This is a natural process. However, it’s called capsular contracture when the scar tissue tightens or hardens around the implants and causes abnormal firmness, hardness, or pain.
  • Pain: Besides pain caused from capsular contracture (see above), breast implants can cause back, neck, and shoulder pain because of their weight. Leaking silicone gel can also cause a painful burning sensation.
  • Anaplastic Large Cell Lymphoma (ALCL): This is a rare kind of cancer of the immune system that is more likely to occur in women with breast implants. [4] If diagnosed early, removing the implants can cure the disease.
  • Autoimmune issues:  Experts disagree on whether breast implants cause specific autoimmune diseases.  However, the fact that implants can cause cancer of the immune system (ALCL) certainly makes it more likely that implants can cause other autoimmune problems.  FDA scientists found that women with ruptured and leaking silicone gel breast implants were more likely to have fibromyalgia, a painful autoimmune disease.[5]  Many women have reported suffering from autoimmune symptoms such as joint pain, hair loss, dry eyes, or mental confusion after getting breast implants, and have also reported that these symptoms often improve or disappear after removing the implants. One study even showed the autoimmune symptoms got better for 3 out of 4 women after they removed their implants.[6]
  • Constant flu-like symptoms: Many women report feeling constantly tired or like they’re trying to get over the flu.
  • Learn more about complications from breast implants in FDA’s consumer handbook.

Besides health problems, some celebrities decide to remove their implants simply because they were annoying or embarrassing. Just to name a few, Heather Morris, Heidi Montag, Pamela Anderson, Victoria Beckham, and Jane Fonda all removed their implants for this reason.

Plastic surgeons refer to breast augmentation as a very simple surgical procedure, and as a result many people think of breast implants as an insignificant surgery with few health risks.  Hearing about celebrities who removed their breast implants sometimes makes women think twice about getting them in the first place.  It helps remind all of us to do careful research before making any decision about putting something inside your body.

ALCL Update: In March 2017, the U.S. Food and Drug Administration (FDA) updated its website to report that breast implants could cause a type of cancer of the immune system called Anaplastic Large-Cell Lymphoma (ALCL). No celebrities have reported ALCL from their implants.

Are you considering breast implants? Find out more information here.

Are you thinking about removing your breast implants? Find out more information here.

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[1] FDA Update on the Safety of Silicone Gel-Filled Breast Implants. Center for Devices and Radiological Health U.S. Food and Drug Administration. Page 7. June 2011

[2] Important Information for Augmentation Patients About Mentor MemoryGel™ Silicone Gel-Filled Breast Implants, Mentor. (FDA Patient Brochure) November 2006. Pages 25-27. http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053d.pdf

[3] Making An Informed Decision Saline-Filled Breast Implant Surgery, Inamed. 2004 Update. Pages 24, 32. http://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm064457.pdf

[4] Miranda et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. Journal of Clinical Oncology. Volume 32, Number 2. January 10 2014.

[5]  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.

[6] de Boer M, Colaris M, van der Hulst RRWJ, Cohen Tervaert JW. Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research. July 2016 DOI: 10.1007/s12026-016-8813-y\