U.S. Asks Halt to Sale of Gel Breast Implants : Health: Silicone devices are targeted. New data obtained by FDA raises concerns over products’ safety.
The Food and Drug Administration on Monday called for a temporary halt to the sale and use of silicone gel breast implants while the agency evaluates recently obtained information that has raised new concerns about the safety of the controversial devices.
“Physicians should cease using them and manufacturers should stop distributing them,” FDA Commissioner David A. Kessler said at a press conference, adding: “The FDA cannot assure women of their safety at this time.”
Kessler said an agency advisory panel will reconvene within 45 days to review the new information and make a recommendation about the future of the devices, which have been implanted in an estimated 2 million women.
The latest action prolongs the months-long drama that has pitted women against women, and raised soul-searching questions about the values of a breast-conscious society. Women, whose strong and often emotional voices have made the debate especially compelling, have argued that the implants have made a profound difference in their lives or they have condemned them as the source of serious and debilitating pain and injury.
While the moratorium is voluntary, Kessler predicted that “all manufacturers and physicians will abide by it.” Dow Corning Wright, the largest manufacturer of silicone gel breast implants, said Monday it had suspended worldwide shipment and sales of the devices.
Saline-filled implants, which are considered safer than the silicone gel devices, are not affected by the FDA decision and will remain available.
Breast implants have been on the market for three decades. About 150,000 women every year have the implant surgery--80% of them for cosmetic reasons, the rest for reconstruction after breast cancer surgery.
There are known problems associated with the devices. These include hardening, caused by the scar tissue that develops around the implant after the surgery, leakage of silicone gel from the implant, rupture of the device and interference with mammography readings.
There also are several suspected dangers, more serious but not as well-documented, including cancer and autoimmune disease. Numerous women have attributed connective tissue disorders, such as arthritis and lupus, to the implants.
While Dow Corning Wright executives said they would comply with the FDA’s moratorium request, they were “extremely disappointed” with the agency’s decision.
The American Society of Plastic and Reconstructive Surgeons said that its members would cooperate with the FDA’s request, but demanded access to the new information upon which the agency based its statement.
“If the agency has new, reliable scientific information on the safety of silicone gel breast implants--and not just anecdotal case reports--that data should be made immediately available for public and medical scrutiny,” said Dr. Norman Cole, president of the society.
Kessler said the latest information, which pertains to implants made between 1975 and 1985, surfaced from two recent private suits against Dow. He refused to make the substance of the documents public, saying they had been sealed by a judge’s protective order. However, he said, “rather than dispelling doubts,” the information “has increased our concerns about the safety of the products.”
In addition, he said, the agency has received a considerable number of case reports from rheumatologists saying that they are seeing an increasing number of autoimmune disorders among breast implant patients. “Those are anecdotal, but they cannot be brushed aside,” Kessler said.
He said that the agency was “particularly concerned” about these case reports “in view of new information that some pre-1985 implants may not have been tested properly, and had significant problems with leakage. These kinds of quality-control problems have not been put to rest by the manufacturers’ recent submissions” to the FDA.
“We’re talking about implants that are put in your body--not for one year, not for five years or 10 years, but that may be in your body for 50 or 60 years,” he added. “This is very serious business.”
But Dan M. Hayes, president and chief executive officer of Dow Corning Wright, a subsidiary of Dow Corning, urged the FDA to “bring science back into this decision” and “rely on experts with appropriate credentials to evaluate immune system response. . . . If this review is done with experts in immunology, we’re confident the process will support the safety of breast implants.”
The FDA is also investigating whether Dow improperly withheld certain studies from the agency, but Kessler said Monday that the agency was “making no allegations today in that regard.”
Dow’s Hayes, in his statement, insisted that the company’s files “have been and continue to be open to the FDA for their scrutiny. . . . Absolutely nothing has been withheld.”
Implants were introduced before the 1976 legislation that gave the FDA the authority to regulate medical devices. However, the law provided that manufacturers of products already on the market could be required at some future point to prove they were safe.
In November, as part of that process, the FDA’s advisory panel--the General and Plastic Surgery Devices Committee--recommended that the implants remain on the market while the research into their safety continued.
The committee said that the manufacturers had failed to prove that the devices were safe--but that there was nevertheless a compelling public health need to keep them available, particularly for reconstruction following breast cancer surgery.
Typically, FDA decisions are heavily influenced by the recommendations of the agency’s advisory committees, which are made up of outside experts.
But Kessler said that the new information was obtained after the committee last met, and that several panel members have since asked for an opportunity to revisit the issue.
Kessler could have reconvened the panel and left the devices on the market, but the new data raised enough concerns “that I felt the moratorium was the most responsible thing I could do,” he said.
Dr. Scott Spear, professor of surgery at Georgetown University and a spokesman for the plastic surgeons’ society, called the move “a bad sign” that probably presaged their ultimate removal from the market.
Moreover, he added, it “creates an unnecessary environment of anxiety and fear on the part of patients who now have these gel implants. Even if the panel decides to leave them on the market, it’s already been at great cost to the patient.”
Kessler said that women with implants need not consider removing them if they are not experiencing difficulties.
