Conditions tied to implant decision

Although a Food and Drug Administration advisory committee last week voted to recommend approval of Mentor’s silicone-gel breast implants, panelists attached several conditions designed to spur the manufacturer to collect long-term safety data.

But a couple of FDA documents suggest that medical device makers, like Mentor, often don’t put much effort into these so-called “condition of approval” studies.

“I think the panel’s vote is motivated a little by wishful thinking,” Cynthia Pearson, head of the National Women’s Health Network, said after Wednesday’s vote. “They thought they could fill in the missing pieces with the post-approval conditions.”

Panelists voted 7-2 to recommend approval of Mentor’s application to resume marketing silicone-gel implants. Since safety concerns spurred then-FDA Commissioner David Kessler to pull silicone-gel implants off the market in 1992, women wanting to enlarge their breasts have first had to try less-popular saline implants.

The panel attached nine conditions to its favorable Mentor vote. Among them: Mentor should be required to continue to follow women in an ongoing study for an additional eight years and establish a voluntary registry of other women who receive its silicone-gel implants. However, the FDA lacks authority to enforce such requirements once the device is on the market.

If the agency approves the company’s application, “it’s very hard to predict or say what conditions the FDA will actually come up with and whether Mentor will comply with those,” Johns Hopkins cancer surgeon Michael Choti, the committee’s nonvoting chairman, said Monday.

A few weeks before the implant meeting, the FDA posted a report on its Web site that raises questions about how seriously medical device manufacturers take condition-of-approval studies. FDA scientists found that only 42 percent of such studies for devices approved from 1998 through 2000 were completed or on schedule, a percentage the scientists called “suboptimal.”

When the FDA approved Mentor’s application to market saline implants in 2000, the agency asked the company to continue collecting safety data from an ongoing study out to 10 years. In a June 2002 memo, though, FDA medical officer Samie Allen wrote that Mentor had collected information on relatively few women, “a major limitation of this study.”

In a statement, Mentor CEO Josh Levine called his company’s 60 percent follow-up rate in the saline-implant study “remarkable,” considering “that this is one of the FDA’s longest-running post-approval studies.” He said Mentor intends to continue following women in its silicone-gel-implant study for a total of 10 years.