The breast implants’ approval by the FDA was not fine-print free. Women must weigh the impact, and costs, of follow-up care.
By Melissa Healy, Times Staff Writer
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 giddy welcome may not last. Even as the two U.S. manufacturers of silicone implants gleefully projected a surge in demand for their products, physicians began poring over the fine print of the Food and Drug Administration’s recommendation and finding reasons for caution.
Like a holiday hangover that sets in before the dishes are washed, the sobering details of the government’s decision are making some doctors less than exuberant about the newly approved implants. As they begin to share their wariness with patients, some expect many women will stick with saline implants or wait for the FDA to give its blessing to a new generation of silicone implants sometime in the next two years.
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.
“Many women were waiting in the wings to see when [the] FDA would approve silicone,” said Brent Moelleken, a plastic surgeon with practices in Beverly Hills and Santa Barbara. Patients intent on getting silicone implants “really look on the bright side of the controversy,” he said. Although many prospective patients will inquire, “my recommendation to them may not be to have surgery” at this time, he added.
Key among the questions that doctors are pondering is the cost of using the newly approved gel implants in the manner outlined as safe by the FDA in its Nov. 17 announcement. The agency recommends that each woman using the implants have her breasts checked by magnetic resonance imaging, or MRI, three years after her surgery and every two years thereafter “over a woman’s lifetime” to check for any ruptures of the implant. If any break is detected in the seal of the device, “the implant should be removed and replaced, if needed,” the FDA added.
Medical insurance doesn’t cover cosmetic breast enhancement. Similarly, the cost of postoperative tracking and repeat surgery, the FDA notes, “may not be covered” by a woman’s medical insurance and “may exceed the cost of her initial surgery.”
Even if women can afford the original breast implant surgery, a subsequent surgery — not to mention periodic MRIs — may be out of their price range.
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.
Plastic and aesthetic surgeons currently are divided on the question of whether “silent ruptures” — breaks in a silicone implant that are not noticed by the patient — need to be replaced for safety. Laurie Casas, a Chicago plastic surgeon, says she believes a broken implant could eventually cause inflammation and so “should be replaced, as you would any broken device.”
Beverly Hills plastic surgeon Richard Ellenbogen, whose view is widely shared among plastic surgeons, counters, “If it ain’t broke, why fix it? Why submit a woman to that trauma?”
Among young women, who are considered a key market for this so-called “third generation” of silicone devices, plastic surgeons predict the FDA’s follow-up recommendations and the improving alternatives will temper enthusiasm. But they acknowledge that many women will get them anyway and simply ignore the FDA recommendations that come with them.
“Most women want to put them in, go on with their lives and forget they got the surgery,” said Beverly Hills plastic surgeon Gary Motykie. “That’ll be a big question, whether they’re going to want to be burdened with that follow-up.”
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.”
Meanwhile, the look and feel of saline implants have been improved by a generation of surgeons who have had only that type of device to offer their patients. To overcome the wrinkles and folds that often mar the appearance of a saline implant in the breast, surgeons have begun to implant them under muscle and other breast tissue.
At the same time, a newer and reportedly better generation of “highly cohesive” silicone devices is making its way through the FDA approval process. Although the silicone in the implants just approved is considered resistant to leakage and running if broken, the next generation — often described as having a consistency similar to that of gummy candy — is designed to be even more resistant.
“Patients that really are interested in gel implants have done their homework” and know what advances lie ahead, said Erhardt, adding, “it will be interesting to see how many people will want to accept the old technology” approved after such exhaustive study by the FDA, when a new generation may be just a year or two down the road.
Copyright 2006 Los Angeles Times