News
04/16/1992
Breast Implants Available only under Controlled Clinical Studies
P92-11 Food and Drug Administration
FOR IMMEDIATE RELEASE Susan Cruzan - (301) 443-3285
The Food and Drug Administration today announced that silicone breast
implants will be available only under controlled clinical studies. Women
who need these implants for reconstruction will be assured access to those
studies.
This decision reflects the recommendations of the General and Plastic
Surgery Devices Panel, which met Feb. 18-20 to discuss safety issues
surrounding the use of silicone gel breast implants.
The panel recognized that the implants serve an important need for
breast cancer patients and recommended that they remain available for
reconstruction under controlled trials. However, it expressed concern about
special problems for augmentation patients because of their greater
difficulty in obtaining good mammography and in determining if an implant
has ruptured.
FDA Commissioner David A. Kessler, M.D., said, "I am acutely aware that
the many women who already have these devices in place are eager for
reliable clinical information. The decision announced today will require
studies ensuring that information will be gathered so that we will learn,
once and for all, how safe these devices are."
The agency is denying pending applications for use of breast implants
for augmentation and providing for continued availability of the implants
for reconstruction purposes on the basis of a public health need.
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Page 2, P92-11, Breast Implant Decision
Two categories of reconstruction patients with an urgent need for the
implants will be able to receive them without delay. The first group
consists of women in whom the reconstruction process had already been
started prior to a Jan. 6, 1992, moratorium on the implants, who have
temporary tissue expanders in place and who are waiting for a permanent
implant. The second group consists of women who need their implants
replaced for medical reasons such as rupture.
Other women desiring implants for reconstruction, including the
correction of severe deformities, will be able to obtain them under "open
availability" protocols, to be set up in a number of months.
"I am highly conscious that some women need these implants for
reconstruction after cancer surgery or traumatic injury, or for certain
congenital disorders," said Dr. Kessler. "While this policy is meant to be
compassionate toward these patients, it is not to be interpreted as
'business as usual.' Our primary goal is to put in place a process to
obtain adequate information about the safety of these devices.
"All of the women in the open availability protocols will be enrolled in
clinical studies, carefully monitored and followed for years to come. They
will be informed of the potential risks involved and will have to give their
consent. To be enrolled in these protocols, their physicians will have to
certify that saline implants are not a satisfactory alternative, and both
physician and patient must agree to abide by the conditions and followup
required under the protocol," he said.
Further tightly controlled research studies will be set up to obtain
more information on safety and effectiveness. They will allow limited
availability for women desiring the implants for augmentation, as well as
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Page 3, P92-11, Breast Implant Decision
for certain reconstruction patients. Manufacturers will be required to
conduct a separate study for each model of implant they wish to market. The
studies will focus on specific safety questions about the implants -- for
example, the frequency of rupture or capsular contracture. Only enough
women to answer these questions will be enrolled in the studies and receive
the implants.
Both the research studies and the open protocols will be sponsored by
the implant manufacturers. FDA must approve them before they will be
allowed to begin.
The studies will help answer questions about side effects, such as
capsular contracture, calcium deposits, interference with mammography
readings, implant leakage or rupture and changes in the sensation of the
breasts.
Questions about possible long-term effects such as immune-related
disorders and cancer will be answered by epidemiological studies of women
who already have implants. Such studies are already underway at New York
University and the University of Michigan. A third study on cancer risk
will begin this year under the auspices of the National Institutes of
Health. Manufacturers will also be required to follow each patient and keep
records on her health experiences.
If these studies establish safety and effectiveness, the manufacturers
will be able to reapply for marketing approval.
In addition, FDA is working with the current and former manufacturers to
set up a centralized registry so that women with implants can be notified
quickly of significant new findings about the devices.
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Page 4, P92-11, Breast Implant Decision
FDA will also require laboratory studies to be conducted by the
manufacturers, under a strict time table, to look at the chemical
composition and toxicity of the silicone material that "bleeds" out of the
implant shell, the strength of the implant shell, its resistance to rupture
and the physical and chemical changes that the implants may undergo in the
body.
FDA has established a toll-free telephone line to provide information
materials to consumers on breast implants. The number is 1-800-532-4440.
It is also available to the hearing impaired by calling TT 1-800-688-6167.
About one million women in this country have received breast implants
for augmentation or reconstruction. Silicone gel breast implants were on
the market prior to 1976, when FDA was given authority to regulate medical
devices. They were permitted to remain on the market until FDA required the
submission of data supporting the implants' safety and effectiveness.
The manufacturers who are seeking marketing approval are Mentor Corp.
and McGhan Inc.
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