Tag Archives: Mentor

Silicone Implants Backed by FDA Panel

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Marc Kaufman, Washington Post: April 14, 2005.

A Food and Drug Administration advisory panel recommended yesterday that silicone gel breast implants made by Mentor Corp. be allowed back on the market for wider use — a surprise decision that came a day after the same panel rejected the application of a rival company.

Mentor officials were delighted by the panel vote.

In explaining their decision, several panel members said they were more impressed by Mentor’s data on how and why implants rupture and by the lower rupture rate of its implants. While Inamed reported a yearly ruptue rate of about 1.4 percent, the yearly Mentor rate was 0.2 percent — a figure that had been questioned by FDA reviewers.

The panel decision was sharply questioned by Inamed officials, who had been criticized the day before for not having sufficiently long-term data.

“Inamed views today’s panel decision as curious and inconsistent with the decision reached by the panel yesterday on Inamed’s [application] — we look forward to working with Dr. [Lester M.] Crawford and FDA staff on addressing these inconsistencies,” Inamed president and chief executive Nicholas L. Teti said in a statement.

About 260,000 American women had their breasts enlarged with implants last year, and an additional 60,000 had received them after surgery for breast cancer.

Because of health concerns, the FDA in recent years has allowed silicone gel implants to be used only in women who had mastectomies and in some who take part in clinical trials; all others received implants filled with a saline solution. Many women say the silicone gel looks and feels more natural, and it is widely used in other parts of the world.

The panel’s decision was also criticized by some public interest groups, which have long argued that the potential dangers of silicone gel implants remain insufficiently studied.

“I think this was a triumph of wishful thinking which overruled the lack of science,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families. “Because of all the conditions, it’s far from a done deal regarding the FDA. It’s not helpful to women to have a product approved on the basis of two years of safety data.”

[…]

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FDA Panel Backs Breast Implants From One Maker

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Gardiner Harris, The New York Times: April 14, 2005.

Silicone breast implants made by a California company should be available to women who undergo cosmetic breast surgery, a federal advisory panel voted on Wednesday, rejecting arguments about serious health problems.

The panel chairman called the 7-to-2 vote to approve an application by the company, the Mentor Corporation, unexpected.

On Tuesday, the panel voted, 5 to 4, to reject a similar application from the Inamed Corporation. […]

The three-day hearing on implants began on Monday and included more than 160 witnesses who gave impassioned pleas to approve or reject silicone implants.

Dozens of women said implants had sickened them severely, and some gave gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears. […]

At the moment, just saline implants are allowed for purely cosmetic operations, even though many patients and doctors say silicone implants feel more natural and look better. Several panel members said they had voted to approved the implants because Mentor made a more convincing presentation than Inamed. […]

Inamed and women’s groups complained about the votes.

“I’m stunned and amazed by a bizarre and strange decision by a few panel members who yesterday demanded longer-term safety data and today accepted shorter-term data,” a vice president of Inamed, Dan Cohen, said.

Dr. Diana Zuckerman, president of the National Research Center for Health Research, called the conflicting votes illogical and predicted that the drug agency would reject both applications.

[…]

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Risking Women’s Health

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SF Gate: April 12, 2005.

IT LOOKS as if two California manufacturers just won’t take no for an answer — even if women’s health is at stake.

In their third attempt, Santa Cruz-based Inamed Corp. and Mentor Corp., have submitted applications for FDA approval that would allow them to sell their silicone-gel breast implants to the general public. […]

If approved, the Food and Drug Administration would lift its ban, imposed in 1992, which limited the use of the implants to controlled research.

Lest the FDA and these manufacturers forget, there’s a reason the ban was imposed.

Numerous reports linked the implants to arthritis, vascular disease and a range of autoimmune disorders that followed after the implants ruptured.

“All the data indicates that rupture is inevitable,” said Diana Zuckerman, president of the National Research Center for Women & Families. “What have these companies shown to prove that it is now safe?”

Not much. […]

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