May 23, 2005 11:32 a.m. EST
All Headline News
(AHN) - Former workers at Mentor Corp. testify in a lawsuit accusing the company of allegedly suppressing information about rupture rates and other safety concerns about their implant devices.
The firm recently received the "go ahead" resume restricted sales of its devices.
The New York Times first printed the sworn statements of John C. Karjanis and Cynthia Fain, two ex-employees and Kim Hoffman - who is leading the group of women with implants filing the lawsuit.
Karjanis says he was told to get rid of records regarding rupture rates. He says the company wanted "an acceptable disposition of materials through fraudulent means."
He says implant packaging sometimes contained fleas and factory workers would hide defective parts above ceiling tiles.
Fain says Mentor misrepresented defect rates and she received thousands of rupture complaints during her three year tenure with the company, which is much more than Mentor has informed authorities about.
Mentor's president and chief executive officer is not specifically addressing the allegations.
The 2003 lawsuit is brought by Hoffman, who claims she suffered extreme fatigue and neurological problems from her Mentor implants during the '90s. She has since had them removed.
In April, the U.S. Food and Drug Administration approved use of Mentor's silicone breast implants if patients sign a consent form acknowledging potential risks. The surgeries must also be conducted by a specially-trained, certified physician and the company must track various other pertinent factors.
Inamed and Mentor corporations want the FDA to lift the 13-year ban on most use of silicone gel implants.
Federal scientific advisers conclude Mentor proved its devices are safe enough for conditional approval, but Inamed needs to do more research.
An FDA review is still ongoing
