After rigorous scientific
review, the U.S. Food and Drug Administration (FDA) today approved
the marketing of silicone gel-filled breast implants made by two companies
for breast reconstruction in women of all ages and breast augmentation
in women ages 22 and older. The products are manufactured by Allergan
Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa
Barbara, Calif.
“FDA has reviewed an extensive amount of data from clinical
trials of women studied for up to four years, as well as a wealth
of other information to determine the benefits and risks of these
products,” said Daniel Schultz, M.D., Director, Center for Devices
and Radiological Health, FDA. “The extensive body of scientific
evidence provides reasonable assurance of the benefits and risks of
these devices. This information is available in the product labeling
and will enable women and their physicians to make informed decisions.”
Now that the products have been determined to be safe and effective,
FDA will continue to monitor them by requiring each company to conduct
a large postapproval study following about 40,000 women for 10 years
after receiving breast implants. FDA often requires postmarket studies
to answer important questions that can only be answered once a product
is in broader use, such as the incidence of rare adverse events.
FDA’s decision to approve these implants was based on a thorough
review of each company’s clinical (core) and preclinical studies,
a review of studies by independent scientific bodies and deliberations
of advisory panels of outside experts that heard public comment from
hundreds of stakeholders. In addition, FDA conducted inspections of
each company’s manufacturing facilities to determine that they
comply with FDA’s Good Manufacturing Practices. Some of the
complications reported in the core studies included hardening of the
area around the implant, breast pain, change in nipple sensation,
implant rupture and the need for additional surgery. However, the
majority of women in these studies reported being satisfied with their
implants.
In the past decade, a number of independent studies have examined
whether silicone gel-filled breast implants are associated with connective
tissue disease or cancer. The studies, including a report by the Institute
of Medicine, have concluded there is no convincing evidence that breast
implants are associated with either of these diseases. However, these
issues will be addressed further in the postapproval studies conducted
by the companies.
“The silicone breast implant is one of the most extensively
studied medical devices,” said Schultz. “We now have a
good understanding of what complications can occur and at what rates.
We also know that women who get these devices will probably need to
have additional breast implant surgery at least once. This is valuable
information for women who may be considering these products.”
Full information about the risks and benefits of the devices can be
found in the package and patient labeling mandated by FDA. The patient
labeling outlines some of the important factors women should consider
when deciding whether to get silicone gel-filled breast implants.
Some of these factors are: breast implants are not lifetime devices
and a woman will likely need additional surgeries on her breast at
least once over her lifetime; many of the changes to a woman’s
breast following implantation are irreversible; rupture of a silicone
gel-filled breast implant is most often silent, which means that usually
neither the woman nor her surgeon will know that her implants have
ruptured; and a woman will need regular screening MRI examinations
over her lifetime to determine if silent rupture has occurred. The
device labeling states that a woman should have her first MRI three
years after her initial implant surgery and then every two years thereafter.
The cost of MRI screening over a woman’s lifetime may exceed
the cost of her initial surgery and may not be covered by medical
insurance. The labeling also states that if implant rupture is noted
on an MRI, the implant should be removed and replaced, if needed.
FDA approved the silicone gel-filled breast implants with a number
of conditions, including requiring each company to: conduct a large
postapproval study; continue its core study through 10 years; conduct
a focus group study of the patient labeling; continue laboratory studies
to further characterize types of device failure; and track each implant
in the event, for example, that health professionals and patients
need to be notified of updated product information.
The postapproval studies will continue to gather information about
the safety and effectiveness of the implants. Information will be
collected about rates of local complications, rates of connective
tissue disease and its signs and symptoms, rates of neurological disease
and its signs and symptoms, potential effects on offspring of women
with breast implants, potential effects on reproduction and lactation,
rates of cancer, rates of suicide, potential interference of breast
implants with mammography, and MRI compliance and rupture rates.
The postapproval studies will be closely monitored by FDA. FDA anticipates
that data from the studies will provide important information for
patients and physicians, and may lead to improvements in device labeling.
For more information, visit www.fda.gov/cdrh/breastimplants.
Download video sound bites from FDA officials at http://media.medialink.com/home.aspx?Story=32701. |