FDA Not Concerned by Mentor Claims

Allegations from a former Mentor Corp. engineer about possible leakage from the company’s silicone breast implants are not a concern to regulators weighing whether to approve expanded sales, a Food and Drug Administration spokeswoman said Monday.

In a letter to the FDA, the engineer said he was asked by Mentor to develop a “low-bleed” patch to seal the implants used by women who try them on externally for size, so they would not leave behind an oily spot.

A higher-bleed patch, which will leak silicone, is used in implanted devices, said the engineer, who asked to remain anonymous.

The Santa Barbara-based company, in a statement, said the allegations were “wrong” and that the engineer had been indicted for stealing breast implants from the company that he tried to sell on EBay Inc.

The engineer, who said he left Mentor in April and was indicted in June, declined to discuss details of the case, but said “there’s a lot of erroneous things” in the indictment.

FDA spokeswoman Julie Zawisza said agency officials “do not have concerns” about the issues surrounding the patches on the implants used for fitting.

In 1992, the Food and Drug Administration sharply restricted silicone implant sales amid charges from several women that leaking silicone from the implants caused chronic, debilitating illnesses.

Mentor said studies showed “negligible levels” of silicone-gel diffusion from its implants, “more than a million-fold below toxicological levels of concern.”

Both Mentor and rival Inamed Corp., also based in Santa Barbara, have received “approvable” notices from the FDA saying they can resume widespread sales of silicone implants if the companies meet certain conditions.

Mentor shares fell 43 cents to $48.27.

Inamed shares gained $1.07 to $85.29.