New FDA Study Reveals More Bad News About Breast Implants


Diana Zuckerman, Ph.D. - (202) 216-9507

Patti Lieberman, Ph.D. - (202) 216-9507

New FDA Study Reveals More Bad News About Breast Implants Almost 80% of women unknowingly have ruptured implants after 10 years WASHINGTON, DC - The National Center for Policy Research (CPR) for Women and Families and the National Women's Health Network today called on the Food and Drug Administration (FDA) to put a moratorium on the sale of silicone gel implants. The two organizations responded quickly to the news that the FDA's own scientists have determined that more than two of every three implant patients had ruptured implants, and that silicone migrated outside the implant area. The FDA's study came as a shock to women with implants, many of whom were assured by their plastic surgeons that breast implants are safe and rarely break. The FDA study is important because it is the first study of "silent rupture" - the breaking of silicone implants in women who had not reported medical problems and did not seek to have their implants removed. The study used magnetic resonance imaging (MRI) to examine women who had implants for at least six years. One-third of the women that the FDA contacted had already had their implants removed because of breakage, pain, or other problems, and those women were not included in this FDA study.

"That means that the actual prevalence of implant rupture is even higher than the numbers reported in this study" according to Dr. Patricia Lieberman, CPR's staff scientist.

The study, reported at the World Biomaterials Congress, includes information that will be extremely troubling to implant patients:

Ø Seventy-nine percent of augmentation patients had at least one ruptured implant within 11 to 15 years, and 48 percent had at least one ruptured implant within 6 to 10 years.

Ø More than one in five women had silicone gel that had migrated outside of the scar tissue that surrounds the implant, and could therefore potentially migrate to essential organs. Migrating silicone is almost impossible to surgically remove, and efforts to remove the silicone can result in surgery resembling a mastectomy.

Ø The earliest implants, made in the 1960's and early 1970's, tended to last longer because they were much thicker. However, two-thirds of the women with implants for 26 years or more had at least one ruptured implant.

Ø Many of the women with ruptured implants had no idea that their implants had broken.

"These results are shocking" states Cynthia Pearson, Executive Director of the National Women's Health Network. " If the FDA can ensure that patients receive accurate information about the risks, and monitor those studies more carefully to ensure health problems are accurately reported, then studies of silicone gel implants could resume for mastectomy patients."

Plastic surgeons recently informed the FDA that they have been telling their patients that implants rupture at a rate of one to two percent per year, whereas the new FDA study indicates that most women will need at least one implant to be replaced during the first 10 years.

"Women can't make informed choices if manufacturers and plastic surgeons provide inaccurate information to them," states Dr. Zuckerman. "Women getting implants at the age of 20 might need at least six more operations just to replace broken implants - which multiplies the expense and the risks of surgery."

Although they have been on the market since the mid-1960's, silicone gel breast implants were never tested on humans until they had been sold to approximately one million women. It was not until 1991 that the FDA required implant manufacturers to conduct studies and submit them to the agency for review. The studies did not prove safety, however, so in 1992, the FDA required the sale of silicone gel implants to be restricted to mastectomy patients or patients with broken silicone gel implants. The new FDA study, which was required by Congress, was released without fanfare by the agency, which has come under fire from women's health advocates for their failure to vigorously regulate breast implants. Although scientists and officials at the FDA have known about these findings for months, the FDA has continued to allow breast implant manufacturers to sell silicone gel implants to patients participating in "studies." For most of the 1990's, those studies were limited to mastectomy patients or patients with ruptured silicone gel implants, but for more than a year the FDA had quietly allowed silicone gel implants to be sold to hundreds of new augmentation patients. Several members of Congress, including leading Democrats and Republicans on the House Commerce Committee, which oversees the FDA, have recently stepped up their criticism of the FDA's failure to appropriately regulate breast implants.

Diana Zuckerman, Ph.D. Executive Director National Center for Policy Research for Women and Families

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