Silicone Breast Implant Manufacturers to Get FDA Hearing

The on-again, off-again saga of silicone breast implants is slated to get another hearing this April, and manufacturers of the products are hopeful that this time they’ll pass muster with FDA.

Inamed Corp. and Mentor Corp. (both in Santa Barbara, CA), two leading manufacturers of silicone gel breast implants, will have their updated premarket approval (PMA) applications reviewed by FDA’s general and plastic surgery advisory panel in a meeting scheduled for April 11-13.

It won’t be the first time that the two companies have appeared before the panel. In 2003, the advisory panel recommended both companies’ implant products for approval. But in early 2004 FDA notified the firms that the products would be withheld from the U.S. market until further information was made available. At the same time FDA issued those ‘not approvable’ letters, the agency also revised its manufacturer guidance on silicone breast implants.

In accordance with FDA procedure, both Inamed and Mentor have filed supplemental submissions to their PMA applications, which will be the basis of the panel’s deliberation and decision at the April meeting.

Inamed CEO Teti: Continuing the dialogue.

Commenting on the pending product approval process, Nick Teti, chairman, president, and CEO of Inamed, said, “We believe our response addresses the revised guidance for breast implants, and includes information sought in the letter we received last January. We look ahead to a continued dialogue with the FDA as we jointly work to move our PMA for silicone gel-filled breast implants forward.”

Teti also announced that Inamed was filing a new PMA for the company’s next-generation silicone breast implant, which has been available outside the United States since the mid-1990s.

Mentor CEO Levine: Regulatory progress.

Saying he was “pleased with the progress of the regulatory review process,” Joshua H. Levine, Mentor’s president and CEO, added, “We believe that the data from our core clinical study, together with the supplemental data we have provided, support the safety and effectiveness of these products.” He noted that the company’s silicone implants will also be reviewed for approval by the therapeutic products directorate of Health Canada (Ottawa), which will convene an expert advisory panel meeting on March 3-4, 2005.

Both Inamed’s and Mentor’s silicone breast implants have long been approved for sale in the European Union as well as many other locations around the world.

Silicone breast implants have been among the most controversial products in medtech history. The products were first introduced in the 1960s. But in the 1980s, patients began to report problems when older implants began breaking and leaking silicone into their bodies. Although no association has ever been proven, it was widely believed that the breakdown of silicone gel-filled implants contributed to the occurrence of many diseases among patients, including cancer, lupus erythematosus, and rheumatoid arthritis. In 1982, FDA proposed reclassifying the implants as Class III devices—an action that was not realized until 1988. Four years later, FDA banned silicone gel implants, except for use in breast reconstruction following cancer surgery.

After thousands of lawsuits—and the Chapter 11 reorganization of silicone supplier Dow-Corning—a billion-dollar class-action settlement was finalized in 1998. The following year, the Institute of Medicine of the National Institutes of Health (Bethesda, MD) released the findings of a research study that reported no link between the implants and any major disease.

In spite of their controversial history, silicone implants are a widely sought-after product for both breast augmentation and reconstructive surgery procedures. The vigor with which Inamed and Mentor are seeking FDA approval is testament to the market demand.

Inamed, with 1200 employees, reported 2004 revenues of $384.4 million, a 10% gain over the previous year. In addition to its breast-implant devices, the company also manufactures products for facial aesthetics and for the treatment of morbid obesity.

Mentor’s 2003 revenues (fiscal year ending March 31) were $422.2 million, up 10% from 2002. Apart from breast implants, the company also manufactures clinical disposables and products for urology and consumer healthcare.

© 2005 Canon Communications LLC

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