US FDA clears breast implant maker of wrongdoing

WASHINGTON, Oct 13 (Reuters) US health regulators said they found no evidence that silicone breast implant maker Mentor Corp. committed any wrongdoing after examining a former employee's allegations that the company withheld safety data.

In a letter to the US Food and Drug Administration, advocacy group Public Citizen said a former Mentor scientist contacted the FDA in June to alert regulators about safety risk data on leaking gel, toxicity levels and other issues.

Mentor and rival Inamed Corp. received initial FDA clearance last year to resume widespread sales of the implants as long as certain conditions, such as providing additional data, were met first.

Final approval for both Mentor and Inamed, now a unit of Allergan Inc., is still pending.

FDA spokeswoman Heidi Valetkevitch, in an e-mail, said the the agency had taken the allegations very seriously.

''The agency conducted a thorough investigation into these charges and found no evidence of wrongdoing and nothing that would raise questions about the safety of the product under review or the integrity of the data submitted to FDA,'' she said yesterday.

The former employee, who worked at Mentor for 15 years but did not want his name made public, also told Reuters he had urged Mentor to submit the withheld data but Mentor refused.

Among the scientist's allegations were that Mentor had presented the agency with invalid data about the amount of silicone that can leak from the implant and enter the body.

''Had I been aware of the problems, I would never have submitted the work to the FDA since it could not be defended,'' he wrote the FDA, according to the letter released by Public Citizen earlier yesterday.

He also alleged that Mentor ''misinterpreted in a manner to conceal'' data on how much the device weakens once it is implanted and failed to give the FDA data on how long the implants last, according to the letter.

Mentor, in a statement, said FDA representatives visited the company's Santa Barbara, California facility in July.

''They asked questions and reviewed documents specific to our preclinical testing. To our knowledge, all questions were answered to the satisfaction of FDA,'' the statement said.

Shares of Mentor closed down 2.4 per cent to 47.69 dollars on the New York Stock Exchange after falling more than 5 percent earlier on Thursday.

Banned for most US women since 1992 amid allegations they can cause long-term health problems, the implants reignited debate at a public hearing last year. A US Senate investigation in July found no reason for the FDA to reverse its conditional approval.

Public Citizen's Health Research Group Director Dr Sidney Wolfe said the FDA should postpone a final decision in light of the former Mentor scientist's allegations,.

''The fact that they (the studies) were done and that they found some serious problems with the safety of the implants is reason enough for the FDA to take them into account and demand that Mentor provide the actual data from the studies,'' he wrote.

The group is critical of the FDA and has called for numerous drugs and a few devices to carry new warnings or to be pulled from the market. Some of the drugs it has targeted are no longer sold, including Abbott Laboratories Inc's discontinued attention deficit drug Cylert and Pfizer Inc's withdrawn painkiller Bextra.

The former Mentor scientist told Reuters he was coming forward because he thought the information would not otherwise be made public. Asked if he thought the implants would be safe if approved by the FDA, he said no. ''Definitely not. There's no way.'' REUTERS DH PM0507