Gel Implant Ruptures Put at 6%
Researchers studying the rupture rate of silicone gel breast implants reported Tuesday that about 6% of the women they studied had experienced such ruptures. The figure, which the researchers described as probably conservative, is far higher than some previous estimates.
“We are on the threshold of trying to find out how common (ruptures) are,” said Dr. Kathleen M. Harris, a University of Pittsburgh radiologist who conducted one of the studies.
The preliminary results of the new research were presented to members of a Food and Drug Administration advisory panel who are deliberating whether the controversial devices should remain on the market. The committee is expected to make a recommendation Thursday after three days of hearings.
FDA Commissioner David A. Kessler said the agency will make a final decision within 60 days of the panel recommendation. In the meantime, the FDA has established a toll-free hot line (1-800-532-4440) to answer questions from the public concerning implants.
Among the critical questions facing committee members is how often the implants break and whether there are serious health consequences associated with such ruptures.
“One of the things that concerns me most is that these implants may rupture, leak or bleed more frequently than we had originally thought,” Kessler said in remarks before the panel. “How do we screen women, effectively and safely, for possible rupture? What should be done when a device ruptures?”
Leakage of silicone from the implants into the body, either through rupture or through slow “bleeding” through the envelope around the gel, has been the subject of intense scrutiny in recent months. Silicone is suspected--although not scientifically proven--to be associated with the development of autoimmune diseases, such as connective tissue disorders, or cancer.
Breast implants have been on the market for three decades, and an estimated 1 million to 2 million women have them. About 150,000 women each year have implant surgery--80% of them for cosmetic reasons, the rest for reconstruction following breast cancer surgery.
Although the newest implants on the market have tougher outer shells that are supposed to retard the bleeding of silicone gel, the consistency of the newer gels is more fluid than earlier models, and FDA officials are concerned that the substance still may pass easily through the envelope.
In one study, Harris found ruptures in 14 of 212 women with implants, or 6.6%.
In another study, Dr. Judy Destouet, a Washington University radiologist using mammography to screen for ruptures, found a rupture rate of 4.6% in 350 women without symptoms, that is, women who had no palpable lumps or signs of disease that might indicate that their implants had broken. The women were screened between August, 1986, and June, 1991, and the average age of the implants was 10.1 years, she said.
Sixteen of the 350 women had ruptured implants, she said, with two of the women suffering bilateral implant ruptures, or ruptures in both breasts--for a total of 18 ruptures.
Officials from Dow Corning Wright, the leading manufacturer of silicone gel implants, have said their studies indicate that the number of ruptures has never exceeded 0.5% in any year. Industry officials are scheduled to testify today.
But both Harris and Destouet said that rupture rates were likely even higher because the screening techniques were not perfect and probably could not detect every rupture.
Furthermore, in Destouet’s study, 17% of the women also had implants that showed signs of “herniation,” that is, damage to the envelope that surrounds the gel. These were not counted as ruptures because there were no overt signs of silicone leakage, she said. However, there may well have been ruptures, which would increase the overall toll, she said.
The researchers, however, said they would discourage younger women--those who are not yet at risk for breast cancer--from undergoing routine mammography to detect ruptures because of the exposure to radiation. They also said they would give the same advice concerning ultrasound procedures because of the expense. Each procedure can cost between $100 and $200.
The panel also heard from several rheumatologists who have treated patients with implants who have experienced a range of autoimmune-like conditions, including arthritis, lupus and scleroderma.
FDA officials also presented data indicating that Japanese women who received breast augmentation in the 1950s and 1960s with injections of liquid silicone have reported a range of disorders, including inflammation and autoimmune-like conditions.
“If the association is real--and I don’t know that it is--then it is an extremely serious one,” said Dr. Harry Spiera, a New York rheumatologist.
Also, Dr. Bernard Patten, a Houston neurologist, said he had seen seven cases of amyotrophic lateral sclerosis, an extremely rare condition also known as Lou Gehrig’s disease, in women with implants.
In November, the panel determined that the manufacturers had failed to establish the safety of the implants, but it recommended that implants remain on the market because of a pressing public health need.
Since that time, however, new information--including studies, reports from rheumatologists and Dow Corning Wright memos that indicated the company was long aware of silicone gel bleed problems--prompted Kessler on Jan. 6 to call for a voluntary moratorium on the sales and use of the implants. Also, he asked that the committee reconsider whether implants should remain on the market.
Implants were introduced before 1976 legislation that gave the FDA the authority to regulate medical devices; thus, manufacturers were not required to meet the current standards for safety. However, the law provided that manufacturers of products already on the market could be required at some future point to prove they were safe.
* BREAST CANCER STUDY: A study finds women with one form of benign breast disease more likely to get cancer. B3
BACKGROUND (Southland Edition, A11)
The government is reconsidering the safety of silicone gel implants after allegations that leaks from the implants cause cancer, damage the immune system and are responsible for other health problems. An FDA advisory panel, which meets through Thursday, will hear from 55 scientific and medical experts, women with implants, consumer organizations and health groups. The FDA says it will make a decision concerning the implants within 60 days after the advisory panel meeting ends. A toll-free hot line has been set up by the agency to answer questions on the implants. The number is 1-800-532-4440, and it will be staffed from 6 a.m. to 4 p.m. PST weekdays.
