Breast Implant Maker Falsifies Data, FDA Says

WASHINGTON —  The Food and Drug Administration, which is expected to announce within days whether it will allow widely used silicone gel breast implants to remain on the market, Monday accused the major manufacturer of the devices of giving false and misleading information about the implants’ safety to consumers who call the company’s toll-free hot line.

The action dealt another serious blow to manufacturers of implants that have been fighting to keep their controversial product available to the public.

The FDA warned Dow Corning Wright, based in Arlington, Tenn., to stop giving out the false information immediately and ordered the company to notify the agency by Thursday of the corrective steps it takes.

“FDA believes that Dow Corning is falsely reassuring women of the safety of breast implants,” the agency said in a statement.

Barbara Carmichael, vice president of the parent Dow Corning Corp., based in Midland, Mich., said that the company was “frustrated and dismayed at the FDA’s misunderstanding of the mission and role of the implant hot line.”

She said that the line was established last July to provide “accurate information to the thousands of women who have become confused and in some cases terrified by the often very misleading and biased information” about implants.

“We object strongly to any characterization of the hot line as providing anything other than accurate information,” she said. “The average phone call lasts 40 minutes from women who are simply distraught as to the safety of implants. It is impossible to script a conversation of that length and of that level of compassion.”

She said the hot line also distributes to all callers an information booklet that includes FDA material “as well as information that we have had verified by various experts as being accurate. To date we have distributed over 60,000 copies.”

Breast implants have been on the market for three decades, and an estimated 2 million women now have them. About 150,000 women undergo the surgery every year--80% of them for cosmetic reasons, the remainder for reconstruction after breast cancer surgery.

Side effects associated with the devices include hardening around the implant caused by the development of scar tissue, leakage of silicone gel from inside the implant, rupture of the device and interference with mammography readings.

There are also several suspected dangers, more serious but unproven, including cancer and autoimmune disease. Numerous women have attributed connective tissue disorders, such as arthritis and lupus, to leakage of silicone from the implants.

In a letter to Dan M. Hayes, president of Dow Corning Wright, the FDA said that “verbal statements have been made . . . which are not factual or have been used in a confusing or misleading context. These statements overstate the safety of breast implants and minimize known or suspected side effects. . . . “

The FDA said that investigators who called the hot line were told that “breast implants are 100% safe” and “that after 30 years of study conducted with patients, there have never been health problems with implants or silicone.”

Moreover, the FDA said hot line staffers have told callers that the risk of joint pain resulting from silicone leakage “has been very sensationalized and never diagnosed by a physician to be related to implants.”

In discussing hardening of tissue around the implant, a frequently occurring condition known as capsular contracture, the FDA said that hot line staffers made “an extremely misleading” comparison to childbirth, saying: “You can have complications when you have a baby, yet people do it all the time.”

In September, the FDA said that it would require the manufacturers of implants to offer accurate information to patients about the risks associated with implants. The agency would regard failure to do so as a “misbranding” of the product, making the manufacturer subject to enforcement action, such as federal seizure of the devices.

The implants were introduced before the 1976 legislation that gave the FDA authority to regulate medical devices; thus, manufacturers were not required then to meet current safety standards. However, the law provided that manufacturers of devices already on the market could later be required to prove they are safe.

In November, an FDA advisory committee found that the manufacturers had failed to prove that implants are safe. Nevertheless, the committee said, a pressing public health need justified their continued availability. Panel members recommended that implants remain on the market while research continued to resolve safety questions.

The FDA is expected to announce by next Monday whether it will permit continued marketing of the devices.

Since the decision by the FDA’s General and Plastic Surgery Devices panel, several events have led one panel member to call for the removal of the implants from the market and several others to express reservations about them.

Earlier this month, a federal jury in San Francisco awarded $7.34 million to a woman after concluding that the rupture of her Dow Corning implant caused a debilitating immune system disease.

Also, the FDA is investigating whether Dow has improperly withheld studies that showed safety problems associated with the devices.

Apart from the FDA investigation, Dr. Norman D. Anderson, a member of the FDA advisory panel and associate professor of medicine and surgery at Johns Hopkins University, claimed in a letter to the FDA that the company had withheld critical study data.

Anderson also told the FDA that he had telephoned the Dow hot line and received information . . . replete with glaring inaccuracies. . . . “

As a result, he urged the agency to act quickly to remove implants from the market and make them available only for research purposes.

Hayes, in a Dec. 27 letter to FDA Commissioner David A. Kessler, responded to Anderson’s letter, calling the charges “unfounded and incorrect.” He said that the company had “fully responded” with all available data under the regulations. “Our books are open,” he wrote.

He added: “Only days before you will make your final decision regarding the future availability of breast implants, we find it disturbing that one of your own appointed panel members (Anderson) goes around the chairperson of the panel to make false and misleading accusations directly to the FDA.”

Other members of the panel also have begun to express concerns about the allegations against the company.

Marc Lappe, professor of medical education at the University of Illinois and a non-voting member of the panel, said in a recent letter to the FDA that Dow had deliberately published only “good” data from a study of dogs that had actually showed “serious pathology” two years after the implantation of the devices. “Thus, the plastic surgery community never saw this or other data which show serious chronic inflammatory changes,” he wrote.

Dr. Elizabeth Connell, professor of gynecology and obstetrics at the Emory School of Medicine in Atlanta, who chairs the panel, said that the committee “did the right thing at the time, based on what we knew.”

“But this is a new wrinkle that may make a difference,” she added. “The ball is now in the FDA’s court.”