Inamed Alters Application for Breast Implants

Inamed Corp. on Monday said that it was altering its application to market silicone-gel-filled breast implants after the company failed to win backing from a Food and Drug Administration advisory panel in April.

The company and rival Mentor Corp., both of Santa Barbara, have been trying to win FDA approval to resume widespread sales of silicone breast implants for the first time since 1992.

In April, an FDA advisory committee voted 5 to 4 against Inamed’s implants, while urging approval for Mentor’s implants by a 7-2 vote. The FDA is considering those recommendations and is expected to make a decision this month.

Inamed said Monday that it had ended the availability of one style of breast implant, No. 153, in U.S. clinical studies. Inamed said it was in final discussions with the FDA regarding expanding access to a cohesive gel implant to replace its 153 product. Inamed expects to provide an update on the matter when it reports quarterly earnings July 27.

Inamed’s shares fell 7 cents to $66.69, while shares of Mentor were down 64 cents to $41.21.