FDAnews Device Daily Bulletin


Dec. 6, 2005

A former Mentor employee is criticizing the company's handling of an alleged flaw in its breast implants, arguing that a fix preventing potential silicone leaks was only applied to demonstration models of the device and not the implants that were actually used.

The whistleblower argued in a recently released letter to Andrew von Eschenbach, the acting FDA commissioner, that Mentor is not taking sufficient steps to prevent silicone oil from leaking into women's bodies from breast implants. While there are patches made of low-bleed elastomers that limit leaks, the company has only used these on demonstration models, the source said. According to the source, whose name was redacted to protect their identity, using the low-bleed patch is inexpensive, only costing a few pennies extra per implant.

This development comes as the agency recently sent an approvable letter to the company regarding its silicone gel breast implants. However, given this situation, the source said they "have serious concerns about the integrity of the company's safety data."