Wed Apr 6, 2005 03:28 PM ET
Reuters

FDA Questions Breast Implant Data Value

WASHINGTON (Reuters) - New data from Inamed Corp. and rival Mentor Corp. on their silicone gel breast implants are of "limited value" in gauging the risk of ruptures, U.S. regulatory staff said in reports made public on Wednesday.

The Food and Drug Administration released the staff reviews ahead of a three-day meeting by advisers next week on whether the FDA should allow silicone breast implants to return after they were banned for most women in 1992 over health concerns.

Many women and plastic surgeons say the silicone devices, which are widely available in other countries, have a more natural look and feel than saline-filled breast implants.

Although studies have failed to find a link between silicone implants and chronic diseases such as cancer, lupus and rheumatoid arthritis, some patients are convinced that leaking silicone can cause sickness.

"These data are of limited value to address the rupture rate over the lifetime of the device due to the short duration of follow-up," the FDA staff wrote about Mentor's information, adding it was also "of limited value to address the local health consequences of rupture due to the small number of ruptures observed."

The reviewers made similar comments about studies by Inamed, that is being bought by Medicis Pharmaceutical Corp.

The agency usually follows the recommendations of its panels, although it overruled advisers for an earlier silicone implant application from Inamed.

In October 2003, an advisory panel said Inamed's silicone implants were safe enough to be sold, but the FDA rejected its application in January and told all implant makers to collect more data about when and how often the devices break.

Inamed shares were off 1.69 percent at $66.96 in Wednesday afternoon trading on Nasdaq. Medicis shares were off 2.46 percent at $28.90 and Mentor shares were off 2.63 percent at $31.90, both on the New York Stock Exchange.

Both companies have said the silicone implants they make now are sturdier than the ones popular in the 1970s and 1980s, adding that the gel is stickier and less likely to migrate.

Dan Cohen, Inamed's vice president of global government affairs, said he had not seen the reviewers' report but felt the company had "followed the (FDA's) guidance and have been able to provide the information necessary" for the panel to assess the product.

Mentor acknowledged the FDA data release in a statement but could not immediately be reached for further comment.

Breast implants can lead to localized complications such as a painful contraction of tissue around the implant. They also can rupture and require repeat operations to replace them.

The FDA advisers are expected to hear emotional testimony on Monday from silicone implant supporters and opponents. On Tuesday, the committee will review Inamed's application and vote on whether to recommend approval. The panel is set to consider and vote on Mentor's application on Wednesday.

Since 1992, the only U.S. women who can get silicone implants are breast cancer survivors and others needing breast reconstruction, or those having an implant replaced, through clinical trials.

Inamed is also seeking FDA approval for another type of silicone implant, called Style 410, but that version will not be reviewed next week.