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Mentor Soars After Approval of Breast Implants

Health: FDA gives its first formal OK to saline products made by two Santa Barbara companies.

May 12, 2000|From Reuters

Shares of Mentor Corp. pushed higher Thursday after U.S. regulators approved continued marketing of the company's saline-filled breast implants.

The Santa Barbara-based company's stock was up $6.44, or 36%, at $24.38 on Nasdaq.

The Food and Drug Administration on Wednesday decided that two leading brands of saline breast implants, including those made by Mentor, were safe enough to stay on the market despite "relatively high" risks of complications such as pain or leaking.

The FDA also approved implants made by McGhan Medical, a unit of Inamed Inc., which is also based in Santa Barbara. Inamed shares were up 69 cents at $40.75 on Nasdaq.

The FDA stressed that women who get breast implants should be warned that they may need additional surgeries if problems--such as breast pain, hardening of the tissue surrounding implants, leakage or deflation--arise.

"We think both stocks are undervalued. This is an enormous positive for the breast implant industry," said John Calcagnini, an analyst at CIBC World Markets.

He suggested that the FDA decision insulates the companies from the threat of future litigation. Both Mentor and Inamed settled lawsuits stemming from problems with silicone-filled breast implants.

The FDA decided to review saline implants after safety concerns arose over silicone-gel implants, which the agency banned for most women in 1992.

The agency said it would permit Mentor to continue selling its implants despite a previously disclosed FDA criminal investigation related to the company's Texas manufacturing facility. Officials at Mentor could not be reached for further comment on the status of the investigation.

Implants filled with saline, or salt water, have been sold in the United States for more than two decades, but the FDA had never formally approved any of the brands.

One study by the two makers showed that complications were so bothersome that 21% of women in one study who got implants for cosmetic reasons required surgery to remove or replace the implants. Among women who received implants to rebuild their breasts after cancer surgery, 39% needed additional surgery.

"Women should understand that breast implants do not last a lifetime," said Dr. David Feigal, head of the FDA's Center for Devices and Radiological Health.

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