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FDA review indicates possible association between
breast implants and a rare cancer
Agency requesting health care professionals to report confirmed
(press release from FDA)
Jan. 26, 2011 -
The U.S. Food and Drug Administration today announced a possible association
between saline and silicone gel-filled breast implants and anaplastic large cell
lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest
that patients with breast implants may have a very small but significant risk of
ALCL in the scar capsule adjacent to the implant.
The FDA is requesting that health care professionals report any confirmed cases
of ALCL in women with breast implants.
In an effort to ensure that patients receiving breast implants are informed of
the possible risk, FDA will be working with breast implant manufacturers in the
coming months to update their product labeling materials for patients and health
"We need more data and are asking that health care professionals tell us about
any confirmed cases they identify," said William Maisel, M.D., M.P.H., chief
scientist and deputy director for science in FDA's Center for Devices and
Radiological Health. "We are working with the American Society of Plastic
Surgeons and other experts in the field to establish a breast implant patient
registry, which should help us better understand the development of ALCL in
women with breast implants."
According to the National Cancer Institute, ALCL appears in different parts of
the body including the lymph nodes and skin. Each year ALCL is diagnosed in
about 1 out of 500,000 women in the United States. ALCL located in breast tissue
is found in only about 3 out of every 100 million women nationwide without
In total, the agency is aware of about 60 cases of ALCL in women with breast
implants worldwide. This number is difficult to verify because not all cases
were published in the scientific literature and some may be duplicate reports.
An estimated 5 million to 10 million women worldwide have breast implants.
The FDA notification is based on a review of scientific literature published
between January 1997 and May 2010 and information from other international
regulators, scientists, and breast implant manufacturers. The literature review
identified 34 unique cases of ALCL in women with both saline and silicone breast
Most cases reviewed by the FDA were diagnosed when patients sought medical
treatment for implant-related symptoms such as pain, lumps, swelling, or
asymmetry that developed after their initial surgical sites were fully healed.
These symptoms were due to collection of fluid (peri-implant seroma), hardening
of breast area around the implant (capsular contracture), or masses surrounding
the breast implant. Examination of the fluid and capsule surrounding the breast
implant led to the ALCL diagnosis.
The FDA is recommending that health care professionals and women pay close
attention to breast implants and do the following:
- Health care professionals are requested to report all
confirmed cases of ALCL in women with breast implants to Medwatch, the FDA's
safety information and adverse event reporting program. Report
www.fda.gov/Safety/MedWatch/default.htm or by
- Health care professionals should consider the possibility of
ALCL if a patient has late onset, persistent fluid around the implant (peri-implant
seroma). In cases of implant seroma, send fresh seroma fluid for pathology
tests to rule out ALCL.
- There is no need for women with breast implants to change
their routine medical care and follow-up. ALCL is very rare; it has occurred
in only a very small number of the millions of women who have breast
implants. Although not specific to ALCL, health care providers should follow
standard medical recommendations.
- Women should monitor their breast implants and contact their
doctor if they notice any changes.
- Women who are considering breast implant surgery should
discuss the risks and benefits with their health care provider.
The FDA published its literature review in a document posted on FDA's website
site today titled "Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast
Implants: Preliminary FDA Findings and Analyses."
The FDA also plans to provide an update on its review of silicone gel-filled
breast implants in the spring of 2011. This update will include interim findings
from ongoing post-approval studies for silicone gel-filled breast implants
currently sold in the United States, adverse event reports submitted to the FDA,
and a review of the scientific literature on these products.
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