Applauding Crawford Resignation, NOW Asks for Reversal on Implants

by NOW Staff

September 24, 2005

The resignation of Dr. Lester Crawford as Food and Drug Administration (FDA) commissioner Friday was welcomed by National Organization for Women (NOW) president Kim Gandy, who said that the agency was being taken in the wrong direction under Crawford.

"We've seen a series of bad decisions coming from top FDA officials, most notably the unjustified delay in approving over-the-counter sales of emergency contraception and the reckless preliminary approval of two applications for risky, unproven silicone breast implants," Gandy said. "All three decisions went against the FDA's own scientific staff and, in two instances, ignored recommendations of FDA advisory panels."

Gandy continued, "The current Food and Drug Administration no longer can boast of its work as the 'gold standard' of drug and device safety and effectiveness. We desperately need new leadership that will not bow to religious anti-birth control extremists as Crawford did or cave in to profit-driven manufacturers who ignore or hide data about their risky drugs and devices - such as with silicone breast implants and a number of prescription drugs."

In response to the FDA's approval of two applications for risky, unproven silicone breast implants, NOW and 15 health and consumer organizations this week sent petitions to the FDA asking the agency to withdraw those approvable letters.

"These companies disregarded acceptable clinical trial procedures, studied too few patients and dropped hundreds of patients who had adverse complications, and according to sworn reports, at one manufacturer falsified data and hid defective implants," NOW President Kim Gandy stated. "In issuing approvable letters, the FDA has abandoned any respectable safety standard to protect women's health."

Gandy continued, "According to the data, women who have lost a breast to cancer and chosen silicone-gel implants are especially disadvantaged by the FDA's reckless decision. The agency is dooming breast cancer patients to a lifetime of multiple re-operations, and a likelihood serious complications. All of the data indicates that these implants will eventually rupture and leak silicone over time." One company, Mentor Corporation, completely failed to study the safety of their implants in mastectomy reconstruction patients.

Further, it appears that the FDA is trying to quickly push through approvals before a Congressional investigation is completed of the FDA implant review and approval process and of the questionable conduct of one of the companies.

NOW and the other petitioners object to a preliminary FDA approval made public on Wednesday of a marketing application by Inamed Corporation. Petitioners stress that Inamed's submission of data was inadequate to project safety data over a 10 year period, as requested by FDA reviewers, and that the company inappropriately manipulated clinical study findings by deleting an implant style that had high rupture rates. Inamed also failed to adequately study all eight breast implant styles for safety and assessed too few patients to provide reliable short- and long-term data.

Inamed Corporation withdrew data on one of its defective implant styles which had a tendency to break within three years and then studied as few as 30 women for one style of implant. This despite the fact that Inamed itself told the FDA several years ago that 580 implant patients were needed to provide sufficient numbers for safety analysis. In addition, the company provided study data from Europe which has been withheld from public review. In its statement announcing preliminary approval for Inamed's marketing application, the FDA indicated that additional data have been submitted by the company which satisfied the agency's concerns - but did not make that information available to NOW or to the public.

The problem of rupture and leakage of breast implants is a serious health risk for women, often requiring many re-operations and multiple implants. Most implants fail in about 10 to 12 years, with some studies indicating that all implants rupture within 15 to 17 years. Thus the question of safety — especially with toxic silicone gel migrating to various parts of the body — becomes critically important. More than half of reconstruction patients receiving implants following breast cancer surgery have needed re-operations, as reported in one recent study, and some require as many as four or more operations.

In the second petition, NOW asks the FDA withdraw the approvable letter sent to Mentor Corporation in July because the company failed to provide a reasonable assurance of long-term safety of its implants and notes that post-approval conditions specified by the agency cannot be substituted for that assurance. The petition asserts that such an action by the FDA is arbitrary and capricious and that the issuance of a preliminary approval is a violation of the requirements of the Federal Food, Drug and Cosmetic Act.

Gandy stressed. "The law does not allow for an 'approve first, test later' approach, which will expose hundreds of thousands of women to serious health risks."

The FDA scientific review staff deemed the Mentor data — as well the Inamed data — insufficient to conclude that the implants would be safe over a 10 year period, as an FDA guidance document required. FDA scientists concluded that based on Mentor's reportedly low rupture rates, some 22,500 silent implant ruptures per year in the U.S. would still occur. But their recommendations were overruled by the Bush political appointees at the helm of the FDA.

The commitments that are being asked of Mentor by the FDA presumably include frequent and expensive MRI examinations to determine whether the implants are ruptured and the conducting of close follow-up of the health conditions of implant patients. NOW doubts that Mentor will honor that commitment as the company previously has 'lost' thousands of women in clinical trials that the company was supposed to be carefully conducting. Close observers believe that many of these implant patients had become injured or ill before they were "lost" in Mentor's follow-up.

In addition to the two petitions, NOW has sent Freedom of Information Act requests to the FDA asking for information about a prior criminal investigation of Mentor Corporation. Earlier this year, former Mentor employees revealed that the company maintained a flawed manufacturing process, hid faulty and contaminated products and that company officials ordered reports about high rupture rates be destroyed.