BACKGROUND: Implants with a polyurethane foam cover have been used by plastic surgeons since Ashley described them in 1970. Overwhelming evidence confirms the benefits of these implants, especially the extremely low incidence of capsular contracture (grades 3 and 4, Baker classification). On the other hand, except for a transient and self-limited rash, there is no evidence that polyurethane implants present more complications than texturized or smooth gel implants. Due to concerns of polyurethane-induced cancer, these implants were withdrawn in United States after approximately 110,000 American women had received them. This fact, together with the probability that these implants will be reintroduced in the United States, suggests that continued monitoring of their long-term safety and effectiveness is mandatory. METHODS: A retrospective study analyzed the outcomes of 996 implants inserted during a period of 15 years. The incidence of early and late complications was analyzed as well as the aesthetic outcome. RESULTS: The complications evaluated included hematoma (0.6%), infection (0.4%), seroma (0.8%), rash (4.3%), wound dehiscence (0%), capsular contracture (0.4%), implant malposition (0.8%), need for revisional surgery (1.2%), implant rupture (0.7%), rippling (1.8%), and polyurethane-related cancer (0%). Regarding the aesthetic outcome, 95% of the patients expressed satisfaction with their final result. CONCLUSION: The polyurethane foam-covered implants have been proven safe for use in breast surgery. They provide the lowest rate of capsular contracture (0.4% in the current study) and excellent aesthetic results.
BACKGROUND: Implants with a polyurethane foam cover have been used by plastic surgeons since Ashley described them in 1970. Overwhelming evidence confirms the benefits of these implants, especially the extremely low incidence of capsular contracture (grades 3 and 4, Baker classification). On the other hand, except for a transient and self-limited rash, there is no evidence that polyurethane implants present more complications than texturized or smooth gel implants. Due to concerns of polyurethane-induced cancer, these implants were withdrawn in United States after approximately 110,000 American women had received them. This fact, together with the probability that these implants will be reintroduced in the United States, suggests that continued monitoring of their long-term safety and effectiveness is mandatory. METHODS: A retrospective study analyzed the outcomes of 996 implants inserted during a period of 15 years. The incidence of early and late complications was analyzed as well as the aesthetic outcome. RESULTS: The complications evaluated included hematoma (0.6%), infection (0.4%), seroma (0.8%), rash (4.3%), wound dehiscence (0%), capsular contracture (0.4%), implant malposition (0.8%), need for revisional surgery (1.2%), implant rupture (0.7%), rippling (1.8%), and polyurethane-related cancer (0%). Regarding the aesthetic outcome, 95% of the patients expressed satisfaction with their final result. CONCLUSION: The polyurethane foam-covered implants have been proven safe for use in breast surgery. They provide the lowest rate of capsular contracture (0.4% in the current study) and excellent aesthetic results.
Authors: Andrew C Weems; Kevin T Wacker; James K Carrow; Anthony J Boyle; Duncan J Maitland Journal: Acta Biomater Date: 2017-06-21 Impact factor: 8.947