Tag Archives: silicone

Silicone: Now a Solid ‘Maybe’

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Melissa Healy, The Los Angeles Times: November 27, 2006.

The days before Thanksgiving are typically quiet in the offices of plastic surgeons. But a long-awaited decision to approve silicone breast implants for women older than 22 prompted a flurry of excited calls and inquiries last week from prospective patients. […]

The agency’s decision “does create a whole host of questions” for women considering silicone breast augmentation and for the doctors who perform those procedures, said Dr. Walter Erhardt, chairman of the American Society of Plastic Surgeons’ public education committee. […]

Cleared but questioned

The FDA’s approval — after 14 years of study — had been expected to end the controversy around silicone gel implants.

The devices were pulled from the general marketplace in 1992 amid concerns that they could rupture and endanger women, possibly contributing to autoimmune diseases. Although a link to health problems was never proved, long-term safety has remained an issue. In the meantime, the implants have remained available to cancer survivors and a wide range of women who agreed to enroll in studies of the implants’ safety.

But the new recommendations present patients and their plastic and aesthetic surgeons with additional uncertainties: Who will pay for the recommended MRI scans? What danger does the FDA foresee if patients, as expected, fail to get them? Does the FDA consider that a ruptured implant device — even one that presents no discomfort or proven danger to the patient — must necessarily be surgically removed and replaced? If so, whose financial responsibility would that be?

“Do you think [insurance companies] are going to say, ‘No problem, we want what’s best for the patient?’ ” asks plastic surgeon Marcel Daniels of Long Beach. “No. A lot of third-party payers have ruled out payment for any treatment — including complications — related to breast implants.”

What to do if those MRI scans detect cracks or breaks in an implant “is another conundrum that’s created by this [FDA] recommendation,” said Erhardt, of Albany, Ga. By calling for costly MRIs to detect silent ruptures and potential replacement surgery in such cases, the FDA is suggesting to patients and physicians that leakage may present safety concerns. “But we still don’t have science that [a silent rupture] creates a harmful situation for the patients. And the FDA hasn’t addressed that either,” Erhardt said. […]

The specialized MRI images required to detect the integrity of a breast implant typically cost between $1,500 and $1,800, said Diana Zuckerman, director of the National Research Center for Women & Families, a nonprofit research and education organization in Washington, D.C. Costs at some centers can reach up to $4,000, and many women would have to travel long distances to get the recommended images, added Zuckerman, whose organization testified against the latest silicone implant approval.

“These young girls are often going into debt that they can’t really afford to get out of, and they’re paying for something on installment that they can barely afford,” Zuckerman said. “I certainly think any woman who is not affluent would be crazy to choose silicone because of the additional cost.” […]

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FDA Ends Ban on Silicone Implants

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David Brown and Christopher Lee, The Seattle Times: November 18, 2006.

The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates.

The FDA is requiring that manufacturers tell women that the implants “are not lifetime devices” and that most recipients will need at least one additional surgery to remove or replace their implants. The agency is requiring the makers, Mentor Corp. and Allergan Inc., to conduct an extensive study of at least 40,000 implant recipients over the next decade and provide their findings to the government. […]

Silicone implants were first marketed more than 30 years ago, but a moratorium was placed on them in 1992 after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was “inadequate information to demonstrate that breast implants were safe and effective.” A major implant manufacturer, Dow Corning Corp., was pushed into bankruptcy because of lawsuits stemming from the problematic devices. […]

Diana Zuckerman, president of the National Research Center for Women and Families, said the approval was the product of corporate lobbying rather than good science.

Zuckerman, a former Capitol Hill staffer who has worked on breast implant safety issues for more than 15 years, said too little is known about the long-term health risks of the implants. She said what is known indicates that some women will experience joint pain, chronic fatigue and leakage. […]

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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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