NEWS RELEASE-New FDA Study Reveals More Bad News About Breast Implants

Thursday, May 18, 2000 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.

"This information will frighten many women, but they need to know the facts,"
said Dr. Diana Zuckerman, Executive Director of CPR. "Any reasonable person
knows that migrating silicone is dangerous, if only because the silicone is
sometimes impossible to remove. The FDA needs to act immediately to protect
consumers, many of whom have come to believe that silicone gel
implants are safe. That is why we are calling for an immediate moratorium on
silicone gel breast implants."

"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

Diana Zuckerman, Ph.D.
Executive Director
National Center for Policy Research for Women and Families
1444 Eye Street, NW
Suite 900
Washington, DC 20005
202 216-9507