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The implants were introduced for commercial use in the 1960s by Dow Corning. But in the 1970s and 1980s, some women with the implants experienced hardened breasts, aches and fatigue. Thousands sued Dow Corning, which eventually filed for bankruptcy, and other implant companies.
In 1992, fearing that the implants may cause chronic disease, the F.D.A. called for a moratorium on them for cosmetic augmentation, although it continued to allow them for breast reconstruction.
But a subsequent study by the Institute of Medicine of the National Academy of Sciences concluded that silicone implants did not cause systemic disease.
Last year, the F.D.A. approved silicone implants made by Allergan and Mentor for cosmetic use in people 22 or older, and for reconstruction for all ages. Besides instructing doctors to advise their patients about the M.R.I.’s and the need for removal, the manufacturers are required to follow their pre-existing study groups of silicone patients for 10 years and to create a database to track 80,000 new patients.
“The guidelines are critically important because we really don’t yet know how best to follow-up these patients, what tests they should get and how often,” said Dr. Michael H. Rosenberg, a plastic surgeon in Mount Kisco, N.Y., who is enrolling women who get silicone implants in a study that will monitor them using M.R.I.’s and ultrasound. “I don’t think it is unreasonable to come up with a standard method to determine the rate of problems with implants.”
To some patients, silicone is worth it, even with the conditions. “The silicone implants look and feel so natural that it doesn’t matter that I will have to spend more money later on M.R.I.’s,” said Katherine John, a substitute schoolteacher in Savage, Minn., who had the surgery last December.
But Ms. Meyer, the bank teller, decided to have saline implants after hearing about silicone’s risks and expenses.
“They told me that if the silicone implant ruptured, it would kind of coagulate in the breast and you wouldn’t feel it,” she said. “The idea that you could be walking around for two years with a rupture until you had the next M.R.I. gave me an uneasy feeling.”
Both women are patients of Dr. Joseph M. Gryskiewicz, a plastic surgeon in Edina, Minn., who is chairman of the emerging trends task force of the American Society for Aesthetic Plastic Surgery.
The debate among plastic surgeons over the F.D.A.’s instructions may have started at a faculty meeting in January at the David Geffen School of Medicine at the University of California at Los Angeles. According to several doctors who attended the meeting, many doctors objected to the guidelines. The group then sent a letter, drafted by Dr. Steven Teitelbaum, a plastic surgeon in Santa Monica, questioning the recommendations to a plastic surgery medical journal.
Last month, at the annual conference of the American Society for Aesthetic Plastic Surgery, in Manhattan, some doctors publicly questioned the recommendations.
“Serial M.R.I.’s are costly, inconvenient and inaccurate,” said Dr. Gryskiewicz, who was a speaker at a breast-implant panel.
Dr. Gryskiewicz said that he nevertheless advises his patients that they will need the tests. But he is also developing an alternative diagnostic tool, called Novalert, a dime-size radio-frequency identification tag that fits on the back of an implant and emits a signal if it senses leaking silicone. “The M.R.I. is the best test we have at the moment, but we need a better system,” he said.
Other doctors said M.R.I.’s occasionally give false-positive results that could cause women with intact implants to have unnecessary surgery to take them out. Still others questioned the advisory to automatically remove a ruptured implant, contending that silicone is benign.
Dr. Richard Ellenbogen, a plastic surgeon in West Hollywood, said he has put in thousands of implants and has never seen major problems. “In my opinion, a rupture is not going to hurt anyone,” he said, adding that “radiologists are going to make a lot of money paying off their $800,000 machines.”
Declining to follow labeling instructions for a medical device is not a legal issue. The F.D.A. regulates drugs and devices, leaving doctors free to practice medicine using approved products in unapproved ways if they deem it medically appropriate.
Supporters of the F.D.A. directives point to studies published in the European Journal of Radiology and the Annals of Plastic Surgery, which found that M.R.I.’s detected ruptured silicone implants with 89 percent accuracy while doctors detected them with 30 percent accuracy.
“These doctors are asking patients to embrace a risk that the patients don’t even know exists,” said Dr. Amy E. Newburger, a dermatologist in Scarsdale, N.Y., who was on the F.D.A. panel that reviewed silicone implants and voted against approval.
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