NONPROFIT CALLS FOR INVESTIGATION OF SILICONE IMPLANT COMPANY
A nonprofit called Oct. 12 for a criminal investigation into Mentor's "apparent failure" to send the FDA data that showed safety problems with its silicone gel implants.
Public Citizen, a consumer advocacy organization, also called on the FDA to wait until it has reviewed all available safety data before deciding whether to approve the implants.
A former Mentor scientist sent a letter to the FDA accusing the company of withholding from the agency a variety of new safety information, according to Public Citizen, which added that the scientist had raised his concerns within the company before writing to the FDA and had urged Mentor to submit the data. Instead, the company refused and fired the scientist, Public Citizen said.
According to the nonprofit, the former Mentor scientist told the FDA that:
Data about the diffusion of chemicals from the implant into the body were invalid and had been fraudulently represented;
Other data understated the magnitude of weakening of the implant shell after implantation, which is relevant to its rupture; and
Still other data showed that as the distance from the front of the implant to the back increased, the estimated lifetime of the device decreased.