Rupture Data on Mentor Implants Called into Question

Allegations made in a 2003 lawsuit against Santa Barbara, CA-based Mentor Corp. reported last month in a New York Times article are raising questions whether rupture data the company provided to the FDA is accurate. However, proponents of the medical device said the agency should approve the product in spite of the revelation.

According to The Times, two former employees of Mentor Corp., whose silicone product was recently recommended by the panel for unrestricted sale in the U.S., said in depositions in the 2003 suit that the company covered up high rupture rates and that employees fearful of management hid defective products from company managers. Those allegations, later found to be unsubstantiated by an FDA investigation, is again raising questions whether Mentor should be allowed to sell its silicone implants for cosmetic use.

Diana Zuckerman, president of the National Research Center for Women and Families, a Washington, D.C.-based nonprofit group that opposes silicone implants, told the Times that the depositions suggest that the low rupture rate Mentor reported to the FDA might not be accurate. She also questioned why its rate was significantly lower than those of competitors.

Mentor’s data is pivotal to the company receiving the panel recommendation, which had rejected the silicone implant made by rival Inamed because of its higher rupture rate.

The depositions of the former Mentor employees were released by the woman who had filed the suit, which was later dismissed. In their statement, the employees said the company had altered rupture data and that the company often failed to meet quality mandates. Opponents of silicone implants are urging the FDA not to approve the product because some recipients complained of severe illnesses after suffering implant ruptures.

Mentor CEO Josh Levine told The Times in a written statement that a criminal investigation by the FDA that began in 1998 and ended in 2002 resulted in no action by the agency. Additionally, Richard D’Amico, a co-chairman of the breast implant task force of the American Society of Plastic Surgeons, said he was aware of the allegations but remained confident in Mentor’s data.