As Agency Delays Silicone Implant Decision, Health Groups Want More Data from FDA on Breast Implant Review

July 15, 2005

By Catharine Richert


FDA missed its July 12 deadline for deciding whether to approve silicone breast implants and is now facing heightened pressure from women’s health advocates to answer more questions about how it has handled the evaluation of silicone implants. Their call comes as two key senators are also investigating FDA’s oversight of the controversial devices.

In a letter sent to HHS May 9, four women’s health advocates including the National Research Center for Women & Families and the Womens Health Network asked the FDA to prove that the agency did not have an inappropriate bias towards implant approval. The groups are not satisfied with Crawford’s response, and want FDA to provide additional information, sources say.

“I assure you that the FDA continues to apply its scientific and regulatory expertise to the impartial review of these product applications,” wrote Acting Commissioner Lester Crawford in his response June 28.

But the groups want FDA to be more clear on several points, including why voting panel member Michael Miller was given a conflict-of-interest waiver despite the fact that he is reported to be a paid consultant to implant maker Inamed, a source close to the issue says. Crawford’s letter said that Miller was cleared for conflict-of-interest before serving on the April device committee that advised FDA on the implants. The source also said that Crawford should supply more information on why FDA does not ask for safety data on different models of the same product, an issue that became particularly important at the meeting when numerous questions were raised about the safety of the Inamed implant model, the source said.

The group is unhappy with Crawford’s original response that devices are typically evaluated as a product category and not by model, but that the manufacturer is required to provide a rationale for why they did not provide separate data. Based on this information, FDA decides case-by-case if additional clinical trial data must be submitted for each model. Finally, the groups are still concerned that the companies did not include data on platinum and other toxicology samples for the implants as called for by the 2004 FDA guidance.

The women’s groups submitted six questions to HHS.

In their May 9 letter, the group asked why FDA approved one implant manufacturer’s study design despite the fact that it did not supply data from women whose implants were removed and not replaced. Crawford’s June 28 response said that FDA is considering revising the guidance to include this data. The groups also wanted to know why, if FDA scientific staff concluded that the companies had not collected enough data to meet the PMA standards set out by the agency, they convened the advisory panel, and why FDA’s own research on breast implant rupture was not included in the meeting presentations.

FDA failed to make a decision on the two implant approvals by its July 12 deadline.

In early April, the device panel voted against letting Inamed’s product on the market but recommended FDA approve Mentor’s. FDA did not return calls by press time to say why the agency missed the decision deadline, though some outside sources say that it is likely because the agency does not want to create any more controversy around Crawford’s confirmation. Crawford’s confirmation has been pending for months. Most recently, it was put on hold by three senators who want Crawford to come out with a stance on Plan B contraceptive and new condom labeling.

The groups’ questions come amidst a Senate health committee investigation. In late June, the committee started questioning stakeholders about conflict-of-interest issues among members of the Inamed/Mentor advisory committee and the safety of the products up for approval (see related story). The probe is ongoing, says a committee spokesperson, and the outcome will depend on what the panel finds and how quickly FDA gets information to the committee. The committee is also looking into depositions submitted in 2003 by two former Mentor employees that say the company made implants prone to rupture and that they hid this information from FDA.



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