http://www.breastimplantinfo.org/what_know/fda2001.html

November/December 2001

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
www.fda.gov/cdrh/breastimplants.

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www.BreastImplantAwareness.org

I personally know someone who was bedridden with painful fibromyalgia
and was expected to die. She now works 8 hours a day working real
estate and she's over 50 years old. She used OPC's. Fibromyalgia is
easy to fix. Oh, yeah, she also does an exercise class once a week.