Polyurethane Implants


Recently, I had the opportunity to reconstruct a patient that presented from Romania with ruptured Polytech Silimed Europe GMBH with micro polyurethane surface MPS mammary implants that were used in the United Kingdom. They were reintroduced into the market in April 2005 having been discontinued all polyurethane-coated implants since 1991. Silicone gel breast implants covered with polyurethane foam had been shown to have an increased rate of carcinoma and sarcoma in lab animals. They were introduced originally in the 1970s with the polyurethane-coat to reduce capsular contracture, having been withdrawn worldwide in 1991 following the concern of carcinogenic breakdown of the polyurethane coat. The evidence of carcinogenic risk is low; however, was found to be significant by the Committee on Carcinogenicity (COC). The COC concluded the implants do give rise to a small possible carcinogenic risk with breakdown of the polyurethane coating over a number of years, leading to the release of small amounts of genotoxic carcinogen 2,4-Toluene Diamine (2,4-TDA).

Later in 2001, reports on safety of the polyurethane-coated implants presented their opinions that there was insufficient evidence available at the time to demonstrate long-term benefits of these devices over other products even with the evidence of reduction capsular contracture compared to the risk of polyurethane-coated breakdown in carcinogenic effects. In November 2003, the Committee on the safety of devices concluded that evidence available at the time showed that there were not substantial benefits in reduction capsular contracture that would outweigh the use of these implants due to the remote but unquantifiable risk of carcinogenic effects. These implants today in the United States are no longer used. They are not FDA-approved and we rarely see these implants when they present to us from patients from European block.