Mentor Hides Defects

This was taken from a May 2005 article written by Shelley Whitcher, entitled, "Mentor Corporation Hid Breast Implant Defects, Including Flea Contamination".

A major manufacturer of breast implants, Mentor Corporation, hid information of defective implants from the Food and Drug Administration (FDA) and consumers, say two former employees. According to a recent New York Times article ("Implant Maker Hid Defects, Workers Said" by Gardiner Harris, May 22, 2005), Mentor purposely withheld important information about its safety record and distributed contaminated products.

The depositions of two former Mentor employees were taken during a lawsuit brought by Kim Hoffman, who claimed that her Mentor implants had made her sick. Although the suit was eventually dismissed, Hoffman provided the depositions to The New York Times last week.
John C. Karjanis, the former product evaluation manager for Mentor, stated under oath that "top executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants because the products 'are in the customers.'" Karjanis also stated that one Mentor manufacturing executive attempted to obtain approval of defective products through fraudulent documents. When confronted by Karjanis, the executive admitted to trying to get one past him.

Moreover, Karjanis stated that Mentor "suppressed a report finding that some implant models had a high failure rate," and that factory workers also hid defective products in the ceiling tiles in an effort to conceal how often the plant failed to make the products properly.During the two years that Karjanis served as the product evaluation manager, Mentor "never met basic quality standards for implant manufacturing."

This is a link to the NY Times piece: http://www.nytimes.com/2005/05/22/national/22implant.html?pagewanted=1&_r=1