Women who say their breast implants made them seriously ill will get to voice their concerns to the FDA at the end of March.
According to the posted agenda for March 25 and 26, a committee will discuss and make recommendations about the benefits and risks of breast implants, including systematic symptoms reported in some patients.
Lauren Caccavone got a single breast implant after doctors told her it would help correct a chest wall defect.
Just one month after her surgery, Caccavone started getting severe neck and chest pain. Soon, the third-grade teacher was suffering from Epstein-Barr virus and chronic fatigue.
“I would go to work and teach, and then I would come home and go back to bed in the afternoon. I’d wake up for my husband when he would make dinner, then go back to bed. I was not living a normal life,” Caccavone said.
Caccavone went to several doctors and got different diagnoses, but the pain never went away.
“It was just getting worse and worse and worse. I would get new symptoms, and then they would become permanent, nothing ever healed,” Caccavone said. “I’ve been to every type of doctor imaginable. I have a ton of medical debt from all this.”
It wasn’t until she found the Facebook group “Healing Breast Implant Illness” that she said she realized her breast implant might be the problem.
“All these things that happened to me that doctors couldn’t explain… were all being described by these women. It was my story, over and over again,” Caccavone said.
Caccavone decided to get her implant removed.
She said most of her symptoms disappeared within days of her surgery.
“My face looked differently, my coloring looked better, I was just so much less swollen,” Caccavone said. “My eyes looked clear and crisp and white, no puffiness, no sick, glazed eyes.”
Caccavone submitted written testimony to the FDA ahead of the hearing, in hopes that it will pave the way for more research into the mystery illness.
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“It’s very personal and I was hesitant to talk about it, because it is such a private thing,” she said. “But now that the FDA is involved and having a hearing, and it could go either way and I have such a big story to tell, I feel like I needed to speak out.”
Caccavone's plastic surgeon, Dr. Marisa Lawrence, prepared to share her own research with the FDA.
Last year, Lawrence began collecting data from more than 112 women who came to her with stories like Caccavone's.
“I looked at when the implants were placed, why the implants were placed, how many years they had them, when did their symptoms begin, what doctors have they seen,” said Lawrence.
The doctor said she was trying to get to the bottom of the mystery illness.
“There are 40 million women in the world who have breast implants and have no symptoms. What is going on with this subgroup of patients?” asked Lawrence.
According to Lawrence’s research, it’s not just one type of implant that’s making women sick.
“Silicone, saline, textured surface, smooth surface, both major manufacturers. They’re all implicated,” Lawrence said.
The only thing her patients seemed to have in common were their stories, she said.
“They’re getting sick one to five years after the placement of the implants, the symptoms are nonspecific, labwork done is nondiagnostic, and we are really not sure as to what is causing this breast implant illness,” Lawrence said.
Lawrence hoped to do genetic testing to look for predispositions for illnesses her patients may share.
However, she said there was still a long way to go in her research.
“One of the biggest problems we have is collecting data. It’s very, very important that we maintain a dialogue and collaboration with our patients,” Lawrence said.
Lawrence said her research was significant because it was not backed by manufacturers.
“I think it makes the study more legitimate,” she said. “There shouldn’t be any bias.”
Allergan, one of the two major breast implant manufacturers and the maker of Caccavone’s implant, stood by the safety of their product.
In a statement, the company said:
“The safety profile of Allergan’s breast implants is supported by extensive pre-clinical device testing, more than a decade of U.S. and European clinical use as well as a large number of peer-reviewed and published studies.
Patient safety and product quality are Allergan’s highest priorities. We are committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards for our products. The FDA has continuously evaluated the use of breast implants in patients, including monitoring adverse event reports, reviewing post-approval studies and available scientific literature, and communicating clearly to physicians and patients when new information has become available.”
Mentor, the other major implant manufacturer, had not responded to a Channel 2 Action News request for comment at the time of publishing.
Channel 2 Action News will follow the FDA panel March 25 and 26. Please check back for updates.