Toxic Shock and Death in 2 women reported to FDA in 96

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FDA 1997 Science Forum Poster Abstract: Brown

Toxic Shock Syndrome Deaths: Post Surgical Infection in Women after Mammoplasty with Saline Breast Implants

http://vm.cfsan.fda.gov/~frf/forum97/97L03.htm,

***** NOTICE ***** this is on the FDA site

Abstract L3 Toxic Shock Syndrome Deaths: Post Surgical Infection in Women after Mammoplasty with Saline Breast Implants

S. Lori Brown, Jane Mann, L. merner, Eileen K. Woo Two deaths resulting from toxic shock syndrome after mammoplasty with saline breast implants or saline breast tissue expanders were reported to the Food and Drug Administration through the Medical Device Report (MDR) system in 1996. One of these deaths was attributed to infection with group A beta hemolytic streptococcal toxic shock syndrome and the other to a staphylococcal toxic shock syndrome. Non-Menstrual Toxic Shock Syndrome (NMTSS) may account for up to 54% of cases of toxic shock syndrome. NMTSS was reported to be due to surgical infection in 16% and 50% of cases respectively in recent studies. To our knowledge, the case reported through the MDR was the first reported case of a post-mammoplasty streptococcal toxic shock syndrome. While toxic shock syndrome is being diagnosed increasingly without association with menstruation, the other change in its presentation has been the increase of streptococcal toxic shock syndrome . Streptococcal toxic shock syndrome may be rapidly progressive, and like the staphylococcal syndrome results in fever, rash, desquamation, hypotension, and multi-organ-system dysfunction. Like staphylococcal toxic shock syndrome, streptococcal toxic shock syndrome has been reported in patients with surgical wound infections. These two cases reported to the FDA will be described.

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