FDA Seeks Inamed Breast Implant Data

Inamed Corp., which last month agreed to be acquired by Medicis Pharmaceutical Corp., on Monday said U.S. regulators had asked the company for more information on a new style of silicone gel-filled breast implants before determining whether to allow their use.

The request comes a week before a key Food and Drug Administration panel meets to discuss applications from Inamed and rival Mentor Corp. seeking permission to once again sell silicone-based implants after their removal from the market more than a decade ago amid safety concerns.

Inamed separately has applied to sell the new silicone implant, called Style 410.

Inamed shares fell 3.4% and Medicis shares were down 3.9% on worries that the FDA’s request for more information would delay the market debut of the new product. Inamed hopes to convince regulators of the safety of silicone implants based on additional data on the original product. If that is accomplished, the company will roll out the Style 410 implant.

“The stock is down because people are assuming there might be some delay in getting the second-generation product onto the market,” Piper Jaffray analyst Thomas Gunderson said.

Inamed said it had received a letter from the FDA outlining the additional information the agency needed so that it could determine whether the new implants were safe and effective for their intended use.

The Santa Barbara company said the Style 410 breast implants were not part of its application that would be considered at the FDA advisory committee meeting April 11-13 and would have no effect on the timing or substance of the meeting.

Adams Harkness analyst Jayson Bedford said the FDA’s request for more information on the new implants was “standard procedure” and unlikely to affect the timing of the new product’s introduction should the ban on silicone be reversed.

Bedford also said there was a good chance the FDA panel would endorse the return of silicone implants. Saline-filled implants currently are the only implants approved for breast augmentation.

Analysts said the FDA’s decision on whether to allow the comeback of silicone breast implants would not have an effect on the Medicis-Inamed merger.

Medicis in March agreed to pay $2.8 billion to buy Inamed, which also makes wrinkle treatments and obesity products, including a device used in lieu of gastric bypass surgery. The deal is expected to close by year’s end.

Inamed shares dropped $2.39 to $68.17 on Nasdaq. Medicis fell $1.19 to $29.29 on the New York Stock Exchange.