Silicone: Now a Solid ‘Maybe’

Melissa Healy, 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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