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


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."

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