FDA Panel Sends Mixed Signals on Silicone Breast Implants

Just one day after rejecting the revised premarket approval (PMA) application of Inamed Corp. (Santa Barbara, CA) for the company’s silicone gel breast implants, FDA’s general and plastic surgery devices advisory panel voted to recommend approval of similar implants from Mentor Corp. (Santa Barbara, CA).

In a 5–4 decision, the panel recommended that FDA issue a ‘not approvable’ decision on Inamed’s implants, then voted 7–2 to recommend Mentor’s devices as ‘approvable with conditions.’

The last time that silicone gel implants were brought before FDA, in October 2003, the panel voted 6–3 to recommend approval of both companies’ products. However, in January 2004, FDA rejected that advice and said that more product information and clinical data would be required before the devices could be considered for a return to the U.S. market.

In arriving at its decision to reject one implant yet approve another, FDA’s panel cited differences in the data on rupture rates supplied by each manufacturer. In both cases, the data were drawn from 10-year performance estimates based on studies of the companies’ products. Inamed reported rupture rates of 3.4% in augmentation procedures, 20.5% in breast reconstructions, and 10.9% in patients who were replacing older implants. Meanwhile, Mentor’s reported data revealed much lower rupture rates: 0.5% in augmentations, 0.8% in reconstructions, and 4.8% for replacement implants.

Wells: Long-term concerns.

Much of the long-term data submitted by the companies was based on extrapolated estimates. Inamed claimed that its main study was carried out for three to four years, in contrast to Mentor’s two- to three-year time frame. Overall, Inamed reported that 2.5% of its devices ruptured in the first three years following implantation and estimated that 13.9% would rupture over a 10-year period. Neither manufacturer would assert how long silicone implants would last.

“Inamed did an excellent job of satisfying the majority of FDA’s concerns,” said James Wells, MD, past president of the American Society of Plastic Surgeons (Arlington Heights, IL). “Unfortunately, the concern over long-term data regarding implant ruptures led the panel to issue a ‘not approvable’ recommendation.”

Levine: Enjoying the news.

Mentor’s take on the panel recommendation was predictably jubilant. “This is good news for Mentor, and great news for doctors and patients,” said Joshua H. Levine, Mentor’s president and CEO. “If ultimately approved by FDA, Mentor’s Memory Gel breast implants will be a significant addition to the options for women seeking breast augmentation or reconstruction in the United States.”

Just as predictably, Inamed expressed disappointment with the panel’s decision. Nick Teti, chairman, president, and CEO of Inamed, said, “We believe our clinical data and related information comply with FDA’s revised guidance document for breast implant PMAs. We intend to work with FDA to address the PMA issues raised by the panel during today’s session.”

Teti: Addressing inconsistencies.

The following day Teti referred to the panel’s action in approving Mentor’s PMA as “curious and inconsistent,” adding, “we look forward to working with [acting FDA commissioner] Dr. Crawford and staff on addressing these inconsistencies.”

Prior to rendering its decisions, the FDA panel heard from more than 150 individual and organizational advocates and opponents of silicone implants. A final decision from FDA is expected with 90 days of the panel’s April 13–14 meeting.

So what’s FDA likely to do?

Among medtech analysts, opinion is mixed. Citing the virtually identical design of the two devices, some analysts believe it is highly unlikely that the agency will rule differently on the two implants. Others note the stringent conditions on which the Mentor implant was recommended—including patient acknowledgment that the device may break and require removal, implant sales limited to specially trained board-certified plastic surgeons, and a 10-year tracking registry—as suggestive of a lukewarm endorsement.

Although silicone breast implants are available in more than 60 countries around the world, FDA removed them from the U.S. market in 1992, except for use in breast reconstruction following cancer surgery. The agency’s ban was based on concerns about leaking implants and their alleged association with numerous diseases, including cancer, lupus, erythematosus and rheumatoid arthritis. Although no definitive disease link has ever been established, the controversy resulted in thousands of lawsuits, a $4.4 billion class-action settlement, and the bankruptcy of Dow Corning (Midland, MI), a major medtech supplier firm.

FDA is expected to come under continued fire as it makes its final decision on silicone implants. Several women’s groups and public advocacy organizations opposed to the market reintroduction of the devices are planning to call upon Congress to conduct hearings on the FDA review process.

Kim Gandy, president of the National Organization for Women (NOW; Washington, DC), referred to the panel’s decision as “deplorable” and implied that panel members had bowed to industry pressure. “In light of dramatically insufficient data and overwhelming reports from women who believe they suffered injury and illness from silicone gel-filled breast implants, they favored corporate greed over women’s health,” said Gandy. NOW has issued an action alert, urging members to “stop the FDA folly” by writing to Acting Commissioner Crawford.

In 2004, there were 264,000 breast augmentations and 63,000 reconstructions performed in the United States. Most of the procedures used saline-filled implants, which are available without restriction.

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 morbid obesity. In March of this year, Inamed announced its intention to merge with Medicis Pharmaceutical Corp. (Scottsdale, AZ).

Mentor, with 2050 employees, reported 2004 revenues (fiscal year ending March 31, 2004) of $422.2 million, up 10% from 2003. 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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