Former Mentor Employees Accuse Breast Implant Maker of Deceptive Practices
Two former employees of medical device company Mentor in sworn depositions in 2003 said the company for years made defective silicone breast implants that were prone to rupture and underreported patient complaints of ruptures, the New York Times reports (Harris, New York Times, 5/22).
An FDA advisory committee in April voted 7-2 to recommend the approval of an application submitted by Mentor to allow the company to sell silicone breast implants to the general population but also called for several conditions to regulate use of the implants. According to Mentor officials, studies indicate that silicone breast implants manufactured by the company last for 25 to 47 years and that 9% to 15% of women who receive them experience ruptures within 12 years (California Healthline, 4/14).
The former employees were deposed as part of a 2003 lawsuit brought by a woman who alleged the Mentor implants made her ill. The lawsuit was dismissed. The Times last week received copies of the depositions from the plaintiff in that case.
One of the former employees, John Karjanis, worked as manager of product evaluation at Mentor between 1996 and 1998. Karjanis said company executives directed him during his tenure to destroy reports on high rupture rates and the poor quality of some implants because the products "are in the customers" (New York Times, 5/22). In addition, Karjanis said that the packaging of implants was sometimes infested with fleas and that workers sometimes stored faulty implant parts in ceiling tiles to conceal them from managers and inspectors.
Karjanis also said some manufacturing executives attempted "to get an acceptable disposition of materials through fraudulent means" (McDonough, AP/Rochester Democrat and Chronicle, 5/22). He said of one incident, "In reviewing the documentation, I found that the documents had been falsified. And in confronting [an operations manager] and asking him to come back to my office, I remember his literal statement was, 'I almost got it past you.'" During the time he worked at Mentor, the company did not meet basic quality standards for the manufacturing of implants and the company's supplier might have sent contaminated silicone, Karjanis said.
The other deposed employee, Cynthia Fain, was supervisor of Mentor's complaint unit for about three years before being fired in 1996 or 1997. Fain said Mentor underreported rupture rates to federal authorities and the company suppressed a report detailing the high rupture rates in some models of implants. Mentor, in its recent filing with FDA, said it received 8,060 rupture complaints between 1985 and September 2003. However, Fain said the company received about 6,000 complaints annually during her tenure, adding that the company did not count complaints made by patients who did not allow the company to inspect extracted implants (New York Times, 5/22).
Mentor President and CEO Josh Levine said, "All of these allegations are old news," adding that the depositions were taken as part of a lawsuit that, "after a thorough review by the court," was dismissed on summary judgment (AP/Rochester Democrat and Chronicle, 5/22). In addition, Levine said an FDA investigation of the company that began in 1998 "included allegations from these two former employees, ... and the investigation was closed in 2002 without further action" (New York Times, 5/22).
Levine said, "Further, FDA conducts regular audits of our facilities, the most recent of which was in February and included a review of our clinical studies and the complaint-handling process. FDA reported no issues or concerns" (AP/Rochester Democrat and Chronicle, 5/22).
Richard D'Amico, co-chair of the breast implant task force of the American Society of Plastic Surgeons, said the depositions were "old news," adding, "Our confidence in the data presented [to FDA] remains absolutely high."
However, Diana Zuckerman, president of the National Research Center for Women & Families, said, "Mentor employees said under oath that their company significantly underreported implant problems. Mentor's new statistics also seem questionable. Are Mentor implants so much better than their competitors' in terms of rupture rates, or are they providing misleading or false information?" FDA officials had no comment on the depositions, saying that Mentor's breast implant application was currently under review (New York Times, 5/22).