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."

FDA Approval System

The FDA has an extensive and complicated procedure for approving and classifying medical devices. Silicone gel-filled implants are considered Class 3, which means they're considered high-risk devices that "pose a significant risk of illness or injury." The pre-market approval for Class 3 devices is more extensive than for Classes 2 and 1.

Health officials noted that the agency has created new consumer materials for the implants, including literature about possible complications, brochures that list questions that a woman should ask before her surgery and what to consider before deciding to get breast implants.

"The FDA's mandate is to determine whether something is safe and effective, and those are two slightly different standards," said Dr. Mark Talamini, professor and chairman of the department of surgery at University of California San Diego Medical Center. "But actually, the general sense is that, in this era, the FDA has been more cautious and concerned about safety than they were in the past."

Talamini said that the FDA has been criticized by innovators in recent years because of the agency's conservative and cautious approvals, and he worries that the United States could lose its global innovative edge.

"It's no question that our medical system produces the best of advancements in medical care, but we're going to lose that," said Talamini.

"Many device companies are beginning to move innovation and development teams over to Europe because the FDA has become very cautious," said Talamini. "I think it's a shame they're doing that because they're viewing the FDA as having higher barriers. There always has to be a balance between innovation and protecting the public."

Robert Field, professor of health management and policy at Drexel University School of Public Health, said he believes the FDA does a "very good job," but tends to do better with pre-market than post-market approval.

"Pre- is more limited because you have a defined number of subjects," said Field. "Post- continues to be problematic because there's so much data to sift through. No review is going to be perfect."

Field said that it would be nearly impossible for researchers to assess every single piece of evidence, but companies have incentives to present "good science" to the FDA.

"They obviously want to get approved, avoid liability and build a good reputation," said Field.

"There are always going to be judgment calls, and it's unusual for anything to be deemed totally safe or totally unsafe," Field said. "It's important to remember that each individual reacts differently. A person has to weigh their tolerance with risk.

"Any decision is only as good as its data," said Field. "Maybe the answer is: breast implants are probably safe, but with caution. A woman should always be aware of the side effects."