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.
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.
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.
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.
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.
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."
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.
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."
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.
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:
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."
"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.