In 15 years, Kathleen Anneken had four sets of silicone gel-filled breast implants, including one of a pair that migrated to her armpit. She`s been
”flat, crooked, big, and black and blue,” she says.
The 46-year-old resident of Covington, Ky., also has been sad, guilty, frightened and furious. Furious enough that in May 1988 she and a partner founded Command Trust Network, a non-profit resource center that offers consumer information on breast implants. Ten months later, she had her last pair of implants removed.
Calls to the network have increased fourfold to 20 a day since the Food and Drug Administration put a voluntary moratorium on manufacturers` shipments and surgical insertion of silicone implants. On Jan. 6, citing new information that implants could cause autoimmune disorders and that pre-1985 models might be prone to leakage, FDA Commissioner Dr. David Kessler said silicone implants ”should not continue to be marketed until this new information is reviewed” by an advisory panel within 45 days.
But the FDA did not disclose details of that information. So the estimated 2 million American women with implants, as well as those who want or need implants, are in an awkward, often frightening position.
”A lot of women are having nightmares,” said Dr. Diane Gerber, a Flossmoor plastic and reconstructive surgeon, referring to patients who have called in recent weeks in reaction to the report.
”They`re having difficulty in day-to-day activities. They`re terrified,” said Gerber, who`s done about 400 implant operations in her eight years of private practice.
Among questions coming into the network`s hot line: Should they keep their implants? Have them removed? Replace them with saline implants
(considered safer than silicone)? Or live with them and the anxiety of not knowing just what the risks are?
In December, a California woman won a $7.3 million lawsuit on the grounds that silicone gel from her ruptured implants damaged her immune system.
Plastic surgeons view the case as unusual. ”We are disturbed that the commissioner (Kessler) has asked physicians to deny patients access to these devices without providing the medical community with the evidence establishing a need for this action,” said Dr. Norman Cole, president of the American Society of Plastic and Reconstructive Surgeons, based in Arlington Heights.
Until the FDA and manufacturers sort out a formal safety ruling on implants, women and their physicians must do the same informally.
The problems to be weighed center on known and unknown side effects. Of the known risks, the most common one affects 3 to 5 percent of implant patients: Scar tissue hardens around the implant, which can cause pain, hardening and result in uneven or dimpled appearance.
Ruptured implants (industry estimates of which range from less than 1 to 5 percent of all silicone implants) must be removed to prevent the spread of the gel throughout the body, but the risks of microscopic silicone seepage are unknown. Seepage is rarely measured; it would be virtually impossible to do so, and trace amounts of seepage generally is expected over time.
According to the FDA, a few researchers have suggested that microscopic amounts of silicone could cause cancer or autoimmune diseases such as lupus, scleroderma (hardened skin) and rheumatoid arthritis in some women. The direct cause is not yet known, according the FDA.
The health research branch of Public Citizen, a Washington, D.C., consumer-advocacy group founded in 1971 by Ralph Nader, says that in the 2,000 complaints they`ve filed on implants, women have also cited chronic fatigue, headaches, fever, rashes and joint and muscle pain.
But, according to an August 1991 FDA statement, although a possible link to cancer has not been ruled out, no studies have found higher cancer rates among women with implants. Likewise, ”there is no conclusive evidence at present that women with breast implants have an increased risk of developing arthritis-like diseases or other autoimmune diseases. Women with breast implants who have developed such diseases may have done so regardless of their implants,” according to the FDA statement.
Implants can interfere with early detection of breast cancer because they can interfere with self-examination or mammography.
But plastic surgeon Gerber, who is also a board member of Y-Me, a breast- cancer support and information group, points out that many mastectomy patients have been helped emotionally by reconstructive surgery.
”If women think they may lose a breast and not be able to get an implant, they may never come in to report a suspected cancer,” she says.
Reconstruction using tissues from other parts of the body rather than implants is another option for mastectomy patients; however, it is a more complex procedure that often involves follow-up surgery, says a spokesman for the American Society of Plastic and Reconstructive Surgeons.
About 10 percent of women with silicone implants have a type coated with polyurethane foam intended to minimize hard scar tissue. According to the FDA, the polyurethane can break down and release small amounts of a chemical that can cause cancer in animals.
The lifetime risk of cancer caused by this implant is not known, but
”would probably be less than 1 in a million, assuming she retained the implants for 35 years,” according to the agency.
At the FDA`s request, the manufacturer, Surgitek, agreed to stop supplying the polyurethane-coated implants; however, considering the minimal risk, the FDA says that cancer fears alone should not prompt removal of these implants. Although there is no known life expectancy of the implants, studies assessing long-term safety are under way, according to the FDA.
The FDA, the plastic surgeons` society and Public Citizen do not recommend removal of any breast implant unless specific symptoms warrant the additional risk of another surgery, such as chronic pain or severe anxiety.
Women who have had implants need to know what type was used. Contact the surgeon`s office and ask for a copy of the sticker in your records that identifies brand name, type, product number, manufacturer and date of implantation.
Annual checkups are recommended for breast implant patients, perhaps more frequently for women experiencing health problems they believe to be related to the implants.
After any implant surgery, a small number of women may have numbness, hypersensitivity, tingling pain or ”pins and needles” sensations in the breast area for up to a year. If these symptoms occur a year or more after surgery, or if you have any other suspicious symptoms, such as breast pain, rash, fever, headaches or muscle and joint pain, see your surgeon.
Saline implants, which are not affected by the moratorium, may be more prone to rupture than silicone implants, so women with these implants should see their surgeons every 12 to 18 months. But if a saline implant does rupture, the salt-water filling is not foreign to the body and probably poses less risk than silicone gel. (However, doctors say many patients prefer the aesthetic resultsof silicone implants.)
– To report medical problems believed to be related to breast implants, call the FDA patient registry at 800-638-6725.
– For a recorded update on FDA announcements on implants, call 800-945-6380.
– To reach the American Society of Plastic and Reconstructive Surgeons`
hot line or physician referral service, call 800-635-0635.
– To receive a packet of information, resources and a physician referral listing, send a self-addressed, stamped envelope and $1 to Command Trust Network, Box 17082, Covington, Ky., 41017.
– For a fee, Medic Alert Foundation`s International Implant Registry will keep registered consumers apprised of recalls and implant information. Call 800-344-3226.
