Panel Asks FDA for Data on Mentor Probe
A congressional subcommittee probing the safety of breast implants told the Food and Drug Administration on Friday to turn over all records from the agency’s criminal investigation of Mentor Corp.
The House subcommittee on oversight and investigations asked the FDA in a letter to produce the file by Oct. 9. The FDA confirmed it had received the demand.
Based in Santa Barbara, Mentor is one of the world’s largest makers of saline-filled breast implants. Questions about the safety of such implants arose in July when the FDA reviewed data that showed nearly one-quarter of implant procedures required a new operation in five years and few implants last 10 years. The most common complaints were pain and hardening of scar tissue, but leakage of saltwater and deflation of implants also were problems.
Mentor came under criticism at the FDA hearing for contacting only a small number of women for its follow-up study. The agency ordered Mentor and its cross-town rival, Inamed Corp., to conduct follow-up studies when it granted them approval to market the saltwater-filled implants in 2000.
Mentor’s difficulties go beyond the hearing. Beginning in 1998, it was the subject of a four-year FDA criminal investigation, which the congressional committee said is now closed. In regulatory filings, Mentor has said it did not know what the probe was about. The company had no comment on Friday’s developments.
However, a USA Today story from March 2000 cited in Mentor’s regulatory filings reported that the investigation centered on “allegations of serious irregularities in breast-implant studies.” The article quoted Mentor general counsel Douglas Altschuler as saying the allegations lacked merit.
The congressional committee opened its investigation in July. At that time, it asked the FDA for documents on Mentor and Inamed and for the Mentor criminal file, if it no longer was active.
The subcommittee’s letter to the FDA was released after the markets closed. Mentor shares rose 55 cents to $30.29 on Nasdaq.