Doctors Voluntarily Halt Silicone Implants : Medicine: Some plastic surgeons criticize the FDA’s call for a temporary ban, saying that it needlessly alarms patients and prospective clients.
On Tuesday, the day after the Food and Drug Administration called for a voluntary moratorium on the sale and use of silicone gel breast implants, plastic surgeon David Hopp operated on two women in his office at Cedars-Sinai Medical Center.
One patient, a 31-year-old hospital worker, made a last-minute decision to receive the less controversial saline-filled breast implants. “It is just not worth it to take the chance that something might go wrong” with a silicone implant, she said.
The second patient, who had had breast implants before and merely wanted some reshaping, said she would not consider bags of saltwater instead of the more natural feeling silicone implants. She received silicone gel implants.
“Look at that wall,” said Hopp, pointing at an office wall with photos of busty, models. “I’ve got centerfolds, women who make their living from their appearance. As long as they believe there is no real danger, they will ask for gel implants.”
The FDA announcement has triggered some confusion and resentment among physicians and their patients but many plastic surgeons said Tuesday they would go along with a temporary halt on gel breast implants.
Some surgeons, like Hopp, were continuing to implant silicone devices in patients who had already been scheduled to receive them. But most were no longer offering their patients this option.
“I think it is the responsible position” to comply with the FDA request, said Dr. Lawrence N. Seifert of Los Angeles.
But plastic surgeons also voiced concern that patients with silicone gel breast implants and those contemplating implant surgery are being unnecessarily alarmed. “Most plastic surgeons feel that (the FDA request) is an overkill . . . (but) we are compelled to stop using the implants,” Dr. Michael Falvey of Torrance said.
The continuing uncertainty is “creating chaos among the patients,” said Dr. Harvey A. Zarem, a Santa Monica-based plastic surgeon and the former chief of plastic surgery at the UCLA Medical School. Zarem said his patients have been kept well informed and “have not panicked.”
“The FDA is obviously trying to do its best to sort out a very complicated problem,” said Dr. William Shaw, chief of plastic surgery at UCLA. “It is probably a position no one is going to be totally happy with.”
On Monday, FDA Commissioner Dr. David A. Kessler said the temporary halt on the sale and use of silicone gel breast implants should continue until the agency completes its review of new safety information. The major concern is that these implants increase the frequency of arthritis, lupus or other connective tissue disorders.
The moratorium is voluntary and will not be enforced by the FDA. Physicians can continue to use the implants, but they may be at greater risk of malpractice claims if complications develop.
An agency advisory panel is to reconvene within 45 days to review this information and make a recommendation about the future of the devices. But the FDA has not said how long it will take to reach its final decision.
The silicone gel devices have been widely used since the mid-1970s and implanted in an estimated 2 million women.
The FDA action only applies to implants that contain silicone gel. Implants that are filled with saline solution, or saltwater, will remain available. The FDA is expected to conduct a detailed review of their safety within the next several years.
Like the silicone gel implants, the saline-filled implants have a silicone shell. The shell is placed in the breast, filled with saline solution and sealed.
An advantage of these saline-filled implants is that they require a smaller incision than the silicone gel implants, surgeons said. But the saline implants are more prone to rupture than those containing silicone gel and many women report that they feel less natural. Some women describe a sloshing sensation in their breasts; one nurse compared it to “a water bed in your breasts.”
Many surgeons called upon the federal government to disclose the new information that has triggered the continuing review. The FDA has declined to release the data, saying that it has been sealed in court proceedings.
“The issue has been politicized,” said Dr. Jeffrey I. Resnick, a plastic surgeon who practices in Santa Monica. Plastic surgeons “have been led to believe that (silicone gel implants) are as safe a product as any other implantable medical device.”
About 80% of breast implants are done for cosmetic reasons. The rest are performed to reconstruct the breast, for example, following its removal for breast cancer.
The FDA, as well as plastic surgeons, says there is no need for women who already have silicone gel implants to consider having them removed or replaced, unless specific problems develop.
Even in advance of the FDA decision, many surgeons said they were performing fewer than normal cosmetic breast implant surgeries. In addition, some had started to use saline-filled implants more frequently.
On the other hand, some patients who wanted silicone implants scheduled their surgeries in November and December so that they would not be affected by the FDA decision, physicians said. Now the major options for patients are to proceed with saline implants or postpone surgery until the FDA reaches its final decision.
One patient who elected to go ahead with surgery later this week is a 41-year-old woman who has already had silicone gel implants twice. Her breasts have become uncomfortable and deformed.
“I was very disappointed (by the FDA decision),” she said. “I had hoped to have the silicone implants.”
The woman, who asked that her name not be used, said she decided not to wait because “I couldn’t go another 45 days with the condition that one breast is in. Even at the end of 45 days, I don’t know what will happen.”
Dr. Frank Kern, chairman of the division of plastic surgery at Cedars-Sinai, says that he is reluctantly abiding by the moratorium, despite problems it is causing for some of his patients. He said he finds himself in the ethically difficult position of being unable to recommend what he considers a superior product.
Kern is particularly concerned about several patients. One, a 45-year-old cancer patient, was a very large-breasted woman who had a double mastectomy seven months ago. For saline implants, she would require a pint and half of liquid in each breast, which would most likely leak and slosh, he said. He may send her to Canada, where the silicone implants are available.
Kim Zaranka, 27, a Lancaster bookkeeper, said she is still planning to get a silicone implant next week with the proceeds of her divorce settlement. “My new fiance . . . thinks it’s great. His ex-wife and ex-girlfriend had it done, and I’m nervous and excited.”
