kathi

note: *However, the women with silicone gel that had migrated outside
the fibrous scar around the implant were nearly three times more likely
to report that they had been diagnosed with fibromyalgia or other
connective tissue disease than women without extracapsular silicone
gel.*

Fibromyalgia and Ruptured Silicone Gel Breast Implants
Women whose silicone breast implants have ruptured and spread silicone
gel beyond the fibrous scar that forms around the implant may be at
increased risk for fibromyalgia, an FDA study indicates.

FDA researchers asked 344 women with silicone gel implants if they had
experienced persistent joint pain, swelling or stiffness; rash on their
breasts or chest; or fatigue. Those in the study also were asked whether
a physician had diagnosed them with Raynaud's disease, Sjögren's
syndrome, scleroderma, chronic fatigue, or fibromyalgia--a chronic
condition marked by fatigue, musculoskeletal aches and sleep
disturbances.

The women also had a magnetic resonance imaging (MRI) examination to
detect whether their implants were intact or ruptured, and whether
silicone gel had leaked outside of the scar tissue immediately
surrounding the implant.

The study found that women with a ruptured implant in which the silicone
hadn't leaked beyond the scar tissue were no more likely than women with
intact implants to report that they had either the persistent symptoms
or diagnosed illnesses listed on the questionnaire.

*However, the women with silicone gel that had migrated outside the
fibrous scar around the implant were nearly three times more likely to
report that they had been diagnosed with fibromyalgia or other
connective tissue disease than women without extracapsular silicone
gel.*

"If other studies are consistent with these findings, women should be
informed of the potential risk of developing fibromyalgia if their
breast implants rupture and silicone gel escapes outside the fibrous
scar capsule," says lead study investigator S. Lori Brown, Ph.D.,
M.P.H., of the FDA's Center for Devices and Radiological Health.

The study, supported in part by the FDA's Office of Women's Health and
the National Institutes of Health, was published in the May 2001 Journal
of Rheumatology. An estimated 6 million to 8 million Americans have
fibromyalgia. About 80 percent of those affected are women.

The FDA took silicone gel breast implants off the market for general use
in 1992 because of safety concerns. They continue to be allowed in
FDA-approved studies for women seeking breast reconstruction or revision
of an existing breast implant. Additionally, those who need to have an
existing implant replaced for medical reasons, such as implant rupture,
are also eligible for these studies.

In 2000, the FDA approved the continued use of two manufacturers' saline
breast implants. (See "Saline Breast Implants Stay on Market as Experts
Warn About Risks" in the July-August 2000 FDA Consumer.)

Further information on breast implants may be found at
http://www.fda.gov/cdrh/breastimplants/.

http://www.fda.gov/fdac/departs/2001/601_upd.html#implants