Breast Implant Risk Disclosure Ordered : Health: The FDA will tell manufacturers to give ‘easily understandable’ written information to doctors so that it can be passed on to patients.
Breast implant manufacturers will be required to inform physicians about the dangers of the devices so they can better advise women who are considering implant surgery, the Food and Drug Administration announced Wednesday.
The agency said the information must be “written in easily understandable language” that doctors can pass along to patients.
“We believe it is vital that women be informed--well before implant surgery--of the known and potential risks,” Assistant Secretary for Health James O. Mason said in a statement.
An estimated 150,000 women receive breast implants annually, including about 80% who undergo the procedure for cosmetic reasons--to enlarge their breasts; the remaining 20% of cases involve breast reconstruction following a mastectomy.
While the agency has no authority to regulate how physicians practice medicine, FDA Commissioner David A. Kessler predicted that most doctors would respect the recommendation.
“The current liability climate is the greatest incentive physicians have to be sure they are in compliance with the agency’s guidance,” he said in an interview. “No physician wants to be caught in a position going against what the FDA is saying. It would be untenable.”
Dr. H. George Brennan, a well-known cosmetic surgeon in Newport Beach, said the FDA order “changes nothing--we have been providing all information on risks to our patients in lay terms for years, as any responsible surgeon would do.” Brennan said that the risks are “minimal” for breast implant surgery and that the main problem is the possibility of hardening of tissue around the implant.
Another top Newport Beach cosmetic surgeon, who declined to be identified, said that the manufacturers of the implants already routinely include one or two pages of single-spaced information for the patients. “This FDA ruling isn’t going to change anything,” he said.
The new rule becomes effective within 30 days.
The implants have been in use since the 1960s. Most consist of a sac filled with silicone gel, while others contain a saline solution. Both types were introduced onto the market before the 1976 legislation that gave the FDA authority to regulate medical devices; thus, manufacturers were never required to prove they were safe.
Their known risks include a buildup of calcium deposits in the tissue around the implant, unnatural firmness, pain, a misshapen appearance, changes in nipple and breast sensation and evidence that implants interfere with the ability of mammography to detect cancerous tumors. The implants can rupture after injury or normal wear over time, releasing the silicone gel filling, which can migrate to other parts of the body.
Questions also have been raised about whether leakage of silicone can cause cancer and such autoimmune diseases as lupus, scleroderma--chronic hardening and shrinking of the body’s connective tissues--and rheumatoid arthritis.
Robert Grupp, a spokesman for Dow Corning Corp., a major manufacturer of breast implants and implant material, said the FDA proposal “sounds very compatible with what Dow has been trying to do throughout the life of this product.” Dow’s information, however, “is written for the physician, so if the FDA wants it in some new form, that’s something we’ll have to consider.”
The FDA is studying safety data submitted by the manufacturers of silicone gel implants and is expected to decide by Jan. 6, 1992, whether to allow the implants to remain on the market. Manufacturers of saline-filled implant devices will be required to provide similar data soon, the agency said.
Kessler said that once the new rule becomes effective, implants “will be considered misbranded if the manufacturer fails to provide the information,” and the products will be subject to seizure by the agency.
Kessler said there was no evidence suggesting that women who already have implants should have them removed, “especially considering that any surgical procedure carries a risk of its own.”
Nevertheless, he added, “a woman who is concerned about the possible risks or who is experiencing problems she thinks are associated with her implants should consult with her doctor to decide what is best in her case.”
Rep. Ted Weiss (D-N.Y.), chairman of the House Government Operations subcommittee on human resources and intergovernmental relations, which has been studying the safety of implants, called the FDA’s action “an important step in the right direction.” But he urged the regulators to go further and remove the devices from the market “unless they are proven safe.”
Pam DeLuca, president of “Why Me?,” a national breast cancer patient support organization, said she feared the FDA’s action would lead to the removal of implants from the market, a move her group and others oppose.
“This is a major issue to breast cancer support groups around the country who believe that reconstruction via implant is the only way most women have of feeling whole again after breast cancer surgery,” she said. “With all of the scare stories about implants, these women have been overlooked.”
Staff writer Robert Scheer contributed to this story.