Medical Device Daily Washington Editor

WASHINGTON With the debate unlikely to subside concerning the safety of silicone breast implants — and the next generation of this implant type — the FDA is planning to look at new data intended to support putting the devices back on the market.

The FDA's General and Plastic Surgery Devices Advisory Panel will review new trial information from both Inamed (Santa Barbara, California) and Mentor (also Santa Barbara) at a meeting, set for April 11-13.

Inamed's silicone gel-filled breast implants premarket approval application (PMA) was reviewed and recommended for approval by the same panel in October 2003.

However, in January 2004, the FDA issued a “not approvable“ letter to the company requesting additional information, and it also revised the guidance for the information to be included by companies submitting PMA applications for breast implants.

Inamed's response to the letter and revised guidance will be the basis for the panel review in April.

Mentor, also a silicone-implant manufacturer, likewise will go before the panel at the April meeting.

Separately, Mentor reported that Health Canada's Therapeutic Products Directorate will convene a panel meeting on March 3-4 to review the company's pending device license applications for its family of smooth and textured silicone gel-filled breast implant products and for its Contour Profile Gel breast implant products.

“We are pleased with the progress of the regulatory review processes in the U.S. and Canada,“ said Joshua Levine, president and CEO of Mentor. “We hope in the future to be able to provide these important options to women in the U.S. and Canada.“

Mentor said it filed the fifth and final module of its silicone gel-filled breast implant PMA with the FDA in December 2003. Following issuance of the FDA's revised guidelines for approval of silicone gel-filled breast implants, the company then in August 2004 submitted an amendment to its PMA providing additional information and answering other questions raised by the agency.

Mentor this past March received European Union CE mark approval and recertification for its silicone gel implant products.

Silicone breast implants have been limited to patients seeking reconstruction surgery following breast cancer. The FDA restricted use of such implants in the early 1990s to cancer patients based on safety concerns. Patients who undergo breast augmentation surgery are currently limited to saline implants.

Most of the debate has been focused on the availability of long-term data demonstrating whether the implants are — or are not — associated with autoimmune disorders and other adverse effects that have been claimed by many women.

At recent FDA panel meetings, the implant makers and some patients have testified that newer implants are improved over the first-generation devices, which have been associated with the risk of leaking and rupturing and the silicone material migrating throughout the body. Many women have claimed to have suffered at least one, or several, chronic conditions, including multiple sclerosis, fibromyalgia and lupus, as a result of ruptured implants.

Critics repeatedly have urged the FDA to approve the devices only after the collection and analysis of several more years of data.

Headquarters move for Global Dosimetry

Global Dosimetry Solutions (Irvine, California), a provider of personal radiation monitoring solutions, recently moved its corporate headquarters in Irvine. The new facility is a single-occupancy, 43,000-square-foot building with increased space, including more space for customer service, manufacturing and badge processing.

The building also will house core operations, including executive management and technical support.

No Comments