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SYSTEMIC DISEASE IN WOMEN FOLLOWING THE INSERTION OF SALINE BREAST IMPLANTS

 

By Britta Ostermeyer Shoaib, M.D. and, Bernard M. Pattern, M.D., F.A.C.P

 

Implant manufacturers are now also asked to show safety and efficacy data on saline filled silicone elastomer shell breast implants, because they have been associated with the development of systemic autoimmune diseases in a number of reports. We report 10 consecutively presenting women with saline filled silicone elastomer shell breast implants, who developed a peripheral neuropathy (n=9) or motor neuron disease syndrome (n=l) at an average latency period of 7 years (range 6 months - 13 years) after implant surgery. Four, of the patients with neuropathy had evidence of systemic vasculitis. Raynaud's phenomena was seen in 8/10, gangrene in 1/10 and vasospasm of major veins of lower extremities on phlebography was seen in 1/10. Implants were removed in 8 patients and 5/8 had ruptured implants. Implant capsule biopsy showed foreign body giant cells and free silicone in 4/5. Pectoralis muscle biopsy showed neurogenic atrophy in 4/5 and myosins in 1/5. Sural nerve biopsy showed loss of myelinated fibers in 3/5 and vasculitis in 1/5. Biceps muscle biopsy showed type II atrophy in 2/6, neurogenic atrophy in 1/6, myositis in 1/6, fasciitis in 1/6 and vasculitis in 1/6. Autodirected antibodies were found in 10/10 (the most common was ANA in 6/10). We suggest saline breast implants might cause or provoke a systemic autoimmune disease with findings of systemic vasculitis in some patients. Further investigations about saline breast implants and associated diseases are needed.




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