• 9 Investigates health concerns with silicone breast implants

    By: Daralene Jones , WFTV Web Staff

    Updated:

    ORLANDO, Fla. - Millions of people across the country have breast implants. Some in the Orlando area have contacted 9 Investigates with claims that their implants made them sick. 

    Their symptoms were similar: fatigue, flu-like feeling, a leaky gut, smelling like chemicals, delusion, vertigo and dizziness, women told 9 Investigates. 

    Women’s stories

    Terri Diaz, of Orlando, told investigative reporter Daralene Jones that she felt like at one point she was dying just before she finally made the decision a few months ago to have her implants removed. Diaz’s friend found information online about other women experiencing similar symptoms.

    "I cried, because I realized this could be it. This could why I'm bedridden. This is why I can't walk up a flight of stairs," Diaz said.

    Diaz told Jones that she got the implants after her children were older and she was done breast feeding. For her, she said, it was time for a “mommy makeover.” 

    "No one could figure out what was wrong with me. Not 100 percent. They had diagnosis', but I never got better,” Diaz said. 

    Watch: 9 things to ask your doctor before getting breast implants

    Faria is married to an Altamonte Springs doctor whose practice focuses on natural healing. He is now seeing her through recovery, after she, too, had her implants removed earlier this year. 

    When doctors provided her lab results, her husband was immediately concerned and wanted a second round of testing. 

    "He called me up and said you need to go back for another draw because I think the lab made a mistake, your results are so bad. Your liver is almost to failure, and your kidneys are in trouble," Faria told Jones.           

    Nearly 20,000 breast implant patients are now mobilized on a Facebook page, gaining national attention. Diaz has since started her own group to provide support for other women. 

    Mentor lawsuit 

    A California attorney filed a lawsuit in February against Mentor, one of three FDA approved manufactures, claiming negligence and failure to warn about potential risks involving breast implants. 

    Mentor and Allergan received something called “pre-market approval” from the FDA in 2006 to expand marketing its implants beyond reconstructive surgeries, but to include enlargements.   

    Steven Teppler, an attorney in Jacksonville, told 9 Investigates that he’s preparing a lawsuit on behalf of other women. He told 9 Investigates women from all over the country have reached out to his firm about their breast implants. 

    "With a sufficient number of lawsuits, and we believe there will be, and we're involved, we believe attention will be given,” Teppler said. 

    >>> Read other 9 Investigates stories <<<

    Teppler said he believes the FDA also dropped the ball. In 2006, when the FDA granted pre-market approval to breast implant manufacturers, the companies were required to perform 10-year studies to monitor safety and effectiveness. That lawsuit already pending in California, alleges by year seven, the overall follow-up rate was only 20 percent. 

    "They had poor follow ups and inadequate data results, and yet they still had this pushed through. We think there were loopholes and shortcuts and misrepresentations that were made such that there was no definitive way to say these were causing problems, and again, we need a study to show there is a problem,” Teppler told Jones. 

    Mentor’s response 

    In its response to the lawsuit filed in California, Mentor said, in part, "A majority of women died or discontinued participation and notes the FDA is empowered to withdraw pre-market approval, and the approvals remain in effect and have never been suspended or withdrawn." 

    Ex-plant surgery

    Women 9 Investigates interviewed for our reporting had their breast implants removed by Dr. Marguerite Barnett, an M.I.T. and Harvard University trained plastic surgeon, with an established practice in Sarasota. 

    Barnett told Jones she has performed what's called “ex-plant surgery,” on about 3,000 women. There is nearly a six-month waiting list to see Barnett because of ongoing health issues women believe are related to their implants. 

    "Typically achy and fatigued, whole range of symptoms. I have a two-page check list with all of these different symptoms and sometimes I'll have checked off 95 percent. There is no model that doesn't leak little bits of silicone out into the body, where it goes, nobody knows," Barnett said. 

    Read: 9 Investigates answers your questions about health risks associated with breast implants

    The manufacturer of Mentor told 9 Investigates in a statement, in part: "The data from our post-approval studies show our products are performing as expected and are safe for use.” (read full statement below)  

    "A vast majority of women do well with implants, but there are some who aren't, and we need to know why," Barnett said when asked if implants should be on the market. 

    Saline or gel, Jones asked. "Exactly," Dr. Barnett said. 

    Barnett told 9 Investigates that she was one of the doctors across the country who was part of the post-study after the FDA granted pre-market approval to manufacturers, Mentor and Allergan, in 1996 expanding marketing of implants

    Barnett said some of the patients who came to her for ex-plant surgery, records she reviewed, showed they were also supposed to be a part of the study, under their plastic surgeons who performed the implant surgeries. 

    "They would say, 'I didn't even know I was in these studies. I haven't been going. I haven't been getting my MRI's,’" Barnett told Jones. 

    FDA executive summary 

    The FDA provided 9 Investigates with a link to its 2011 executive summary, from a panel review, noting both manufacturers (Mentor and Allergan) encountered challenges. The FDA said at the time, follow up rates were lower than expected. 

    That executive summary acknowledged the studies may not provide the data necessary to definitely answer questions about illness. The FDA revealed three months ago more research that shows there is an association with implants and a rate type of lymphoma.

    In a response to our questions, the FDA told 9 Investigates, in part, "... women considering breast implants should know that these implants are not lifetime devices. The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery. The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape. The FDA issued a consumer update that contained five important things to remember for patients considering breast implants. The FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.” (See full statement below)

    "I got them because they were FDA approved and now that approval means nothing to me," Faria told Jones. 

    She is also in the process of having her implants examined by a private lab for analysis. Barnett told 9 Investigates that she is holding onto the implants she removes because she, too, hopes to do more extensive research on the safety and effectiveness of implants." 

    Watch: 9 Facts: Breast implants and cancer

    Full statement from Mentor: 

    "At Mentor, we are guided by patient safety and science, and patients can be assured that the science and long-term data from multiple clinical studies, including two 10-year, prospective clinical trials, support the safety and efficacy of our FDA-approved breast implant products that have been chosen by surgeons for millions of women worldwide.  We adhere to the highest standards of quality and closely monitor the performance of our products. We also continue to support ongoing clinical studies and share updated product safety information with surgeons in our product labeling and with patients in brochures and online as appropriate. 

    The totality of the data and scientific literature continue to support the safety of Mentor’s silicone breast implants, and we are defending against the allegations in the lawsuits you referenced. We also continue to work closely with the FDA and take our study obligations very seriously. The data from our post-approval studies show our products are performing as expected and are safe for use.  

    As with any surgical procedure, it is important for patients to understand the benefits and potential risks when deciding to have breast implant surgery and that breast implants are not lifetime devices. There are certain known complications and adverse outcomes associated with breast implants, the most common of which are capsular contracture, reoperation, implant removal, and rupture or deflation of the implant. Part of the success of any surgery is the follow-up between a doctor and patient. Regular exams based on established medical protocols and guidance from health care providers can prevent or detect known complications with breast implant surgery." 

    Answers to our questions to the FDA:

    9-Investigates question

    Is the FDA currently reviewing and/or investigating claims from patients who say their implants made them sick? If so, what does that review entail? I understand that a new report shows some may be linked to a rare form of cancer, but I’m talking about women who claim their implants molded, cracked, etc, and the fluid bled into their system causing them illnesses such as, but not limited to: flu-like symptoms, rashes, fatigue, leaky-gut,  changes in mood or personality,  chest pain, decreased visual acuity or  double vision; depression; dizziness; eye inflammation; headaches; hearing and balance disturbances; insomnia; irritable bowel syndrome; ringing in the ears, etc.?

    FDA response:

    "To date, with the exception of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the FDA does not have evidence linking breast implants to a wider range of illnesses.  Systematic reviews of the breast implant literature have shown insufficient evidence of lymphoma, brain cancer, cervical cancer, connective tissue diseases or neurological events associated with breast implants. Of note, a Systematic Review of Selected Adverse Outcomes and Symptoms in Women with Gel Breast Implants published by Tufts University in 2015 did find some evidence of a potential association (not necessarily a causal relationship) between silicone gel-filled breast implants and lung cancer, rheumatoid arthritis and suicide. These and other endpoints are currently being studied in post-approval studies.

    We monitor for adverse events in women with breast implants using a variety of post-market surveillance tools, including medical device reports, post-approval studies, and by periodically reviewing medical literature. The variety of data sources and surveillance tools available to FDA provides us with the means to comprehensively monitor the safety and effectiveness of silicone breast implants on an ongoing basis. The FDA is committed to working together with patients and other stakeholders to evaluate the safety of breast implants and other marketed devices. FDA has been working closely with multiple stakeholders to facilitate the development of a National Breast Implant Registry (NBIR) to provide platform to evaluate the safety and performance of breast implants using real-world data. Patients and health care providers can assist in collecting data about adverse events by reporting to the FDA through the FDA’s MedWatch program any problems they observe with their breast implants." 

    9-Investigates question

    The FDA granted Mentor Worldwide and other companies a PMA to market implants first for reconstructive surgery, and then for augmentation. In the documents I've reviewed, that PMA required a 10-year study, during which the companies were required to continue gathering data as to the effectiveness and safety of the implants. It appears, based on what I’ve reviewed, in the case of Mentor, the company experienced very low response levels. Are there any consequences for such actions? Were they required to get more people in the study, start over?

    FDA Response:

    "In 2011, FDA updated the General and Plastic Surgery advisory panel on the status of the ongoing post-approval studies (PAS) with the goal to identify approaches that would maximize the feasibility and successful completion of mandated post-approval studies. You can learn more about the discussions, including progress in patient enrollments for all studies, from the meeting materials for the FDA’s August 2011 meeting of the General and Plastic Surgery Advisory Panel. 

    Following the advice from the panel meeting, in 2015, Tufts University provided the Systematic Review of Selected Adverse Outcomes and Symptoms in Women with Gel Breast Implants (Evidence Review), which looked at all evidence available to date and found insufficient evidence of an association between silicone gel-filled breast implants and these rare outcomes.  Therefore, in 2015, the FDA notified breast implant manufacturers that they are no longer required to conduct case-control studies to study Hodgkin’s lymphoma, brain cancer, cervical cancer, rare connective tissue diseases (CTDs), or rare neurological events. The FDA remains committed to continually assessing the safety and effectiveness of these devices. The two Large PASs (final results can be found on PAS website Allergan and Mentor) were revised/replaced with two ongoing post-approval studies. In addition, FDA has been working closely with multiple stakeholders to facilitate the development of a National Breast Implant Registry (NBIR) and Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) to provide platforms for additional long-term studies to evaluate the safety and performance of breast implants using real-world data." 

    9-Investigates question

    During their study, did the FDA every receive or has it since received any evidence that patients receiving the implants could be experiencing any side effects? If so, can you describe what they were and what the FDA did to act on those effects? 

    FDA Response:

    "Women considering breast implants should know that these implants are not lifetime devices. The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery.  The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape. The FDA issued a consumer update that contained five important things to remember for patients considering breast implants.  

    The FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Our analysis shows the most frequent complications and adverse outcomes experienced by breast implant patients to include capsular contracture, reoperation, and implant removal (with or without replacement). Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval. 

    And, as you  know, women with breast implants may have a very small but increased likelihood of being diagnosed with anaplastic large cell lymphoma.

    You can read more about known local complications and side effects on this webpage describing breast implant complications." 

    9-Investigates question

    In general, what are the resources at the FDA to monitor pre-market approvals? How many on staff are monitoring, what does that monitoring entail? 

    FDA response:

    "The FDA uses a number of methods and data sources to monitory the ongoing safety and effectiveness of marketed devices, including medical device reporting, analysis of incoming signals, post-market studies, review of the scientific literature, and registries." 

    9-Investigates question

    How many Class III medical devices currently have pre-market approval? 

    FDA response:

    "An exact number of medical devices with Class III, pre-market approval (PMA) cannot be determined.  Many PMA submissions have multiple models or sizes of devices within the application, and PMA supplements may subsequently change these models or introduced new models after they are initially introduced. FDA’s database for PMA submissions can be accessed and searched by clicking here. 

    9-Investigates question

    Are there any plans being reviewed to determine whether breast implants should be removed from market or suspended? If not, why? 

    FDA response:

    "At this time, the FDA is not removing breast implants from the market.The FDA does not have evidence linking breast implants to a wider range of illnesses."

    Are silicone breast implants making women sick?
    Are silicone breast implants making women sick?
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