FDA Can't Win: Critcized for Being Too Cautious, Not Cautious Enough ...

June 23, 2011— -- Advocacy groups cry foul over the Food and Drug Administration's announcement that silicone gel-filled implants are "mostly safe." Even though government health officials gave silicone implants the stamp of approval Wednesday, they said that women who have implants would likely experience complications and need future surgery to remove or replace them over time. They also said that more data is needed to fully understand the device's safety and efficacy.

In the report, authors wrote: "Patient follow-up rates are lower than anticipated, limiting the ability to draw definitive conclusions and to detect rare complications."

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health who presented the data, warned that follow-up visits, along with routine MRI scans -- to screen for infections and "silent ruptures" -- are crucial for women who receive the implants.

While noting that the most common complications include hardening around the implants, wrinkling, asymmetrical pain and infection and rupture, Shuren said "the longer the woman has the silicone implant, the more likely she is to experience local complications or adverse outcomes."

Because of the evidence of complications, advocacy organizations, including the nonprofit Public Citizen, expressed outrage following the FDA's safety announcement.

"Public Citizen continues to oppose the FDA's 2006 decision to return silicone breast implants to the market for cosmetic use in women for augmentation," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in a statement. "The agency's newer information about the risk of implant-associated lymphoma and the previously known risks are serious enough to warrant advising women against having these implanted."

In 2006, the FDA approved the silicone implants after they'd been off the market for 14 years. Since that time, health regulators have conducted post-approval device reviews for augmentation and reconstructive purposes.

Rep. Rosa DeLauro, D-Conn., wrote a letter to the FDA in February asking for more information about post-market study approvals, and after Wednesday's announcement, she continued to question the legitimacy of post-market studies overseen by the FDA.

"It is ... very clear to me that post-market studies must be taken more seriously if they are to remain part of the FDA's approval process," DeLauro said in a statement. "Post-market studies that are poorly designed, poorly conducted or unfinished are not scientifically meaningful, and should not be considered so. When Congress gave the FDA the authority to approve devices needing post-market studies, we did so with the intent that the agency would rely on their scientific merit for continued approval of the device."

Despite the questioning, health officials said they're confident in the post-market data so far.

"We think the data is good at this point," said Shuren. "We also think there are certain limitations in the data, and we'd like to see higher follow-up rates. Right now, we think the tide is turning, and we're starting to see improvements in follow-up rates."