Over an 8 month period in 1996, the FDA received two reports of deaths purportedly due to toxic shock syndrome in women after augmentation mammoplasty. There is some risk of infection associated with any surgery, but deaths due to cosmetic surgery are of particular concern because the surgery is elective and usually performed on an otherwise healthy individual. FDA undertook a study to characterize the infection reports related to breast implants. The FDA identified 1971 reports of infections related to breast implants reported during 1977-1997 . The study reports included silicone gel-filled breast implants (62%), saline-filled breast implants (32%), and tissue expanders (6%), which are temporary implants to expand the tissue in preparation for a permanent breast implant. Many of the reports merely stated that there had been an infection without any supporting details (45.5%). The infecting organism(s) was reported in 8% of reports and included Staphylococcus sp., Pseudomonas sp., Bacillus sp., Clostridium sp., Serratia sp., Mycobacteria sp., Scedosporium sp. and Aspergillus sp.
FDA also noted a wide range in time from mammoplasty to the reported infection. It was of interest that over half of the infections were reported to occur over 26 weeks after the implantation. This is consistent with the possibility for biofilm formation and may be a risk factor for capsular contracture [18,19]. Biofilms are a surface film of microorganisms which adhere to solid surfaces such as implants. A recent study suggested that infection rates related to initially inserted breast implants are estimated at 2%, with an average cost of $20 000 for medical and surgical treatment .
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