CENTRAL FLORIDA — Local women are taking their fight against breast implants to the nation’s capital.
They first contacted 9 Investigates more than a year ago with claims their silicone gel-filled implants made them sick, and that they only got better once the implants were removed.
An FDA spokesperson confirms the closed-door meeting to 9 Investigates. The public and media were not allowed to attend.
The Central Florida women who attended the meeting said they want more transparency about the ingredients as well as better public awareness about risks that sometimes don't show up for years.
They also want manufacturers to provide doctors with a checklist – that must be signed -- warning women about illnesses some feel are only caused by implants and a rare cancer that's already been linked to them.
“I’m still having trouble digesting food,” said Terri Diaz, who was one of 20 women who recently went to Washington to meet with the FDA.
Diaz is still trying to get her body back to a healthy state after she finally had her breast implants removed a year and eight months ago with a procedure commonly called, "ex-plant" surgery.
“That's what we're trying to do, hold the FDA accountable. They're supposed to protect us,” Diaz said.
Last summer, 9 Investigates first reported about women blaming their implants for unexplained illnesses.
At the time, nearly 20,000 women were discussing the problem in a Facebook group. There are now more than 50,000 in that group.
Diaz also formed a Facebook group specifically for Florida women. It has the attention of nearly 2,000 implant patients.
Dr. Marguerite Barnett has a six-month waiting list for women who want their implants removed, and has expressed frustration with the FDA for not setting up a registry promised to track the implants.
“We have no idea of the failure rate, other than what the manufacturers choose to report,” Barnett said. It's sad that we're lacking all of this basic data.
The FDA granted pre-market approval to two breast implant manufacturers in 1996, expanding marketing of implants, but both companies were required to perform post studies to monitor safety and effectiveness.
Dr. Barnett says some of her patients never received proper follow-up care.
And although manufacturers do provide warnings about the health risks that can be associated with the class three medical devices, there are questions about whether patients are getting the message.
“So much of it is in technical terms, I think we really have failed to give really good informed consent,” Barnett said.
One of the implant manufactures told 9 Investigates in a statement they are partnering with groups to develop that breast implant registry -- to better understand the cause the cause, incidence and potential risk factors associated with that rare form of cancer--no mention of other illnesses.
The FDA did not commit to any changes during the meeting, but told us 9 Investigates that they continue work to develop that registry.
The women in that meeting said they feel the FDA is strongly considering an Advisory Committee Panel meeting on breast implant issues.
Cox Media Group