Long-term safety and efficacy of polyurethane foam-covered breast implants.

[BACKGROUND] Polyurethane foam-covered silicone gel-filled breast implants, introduced in the 1970s, were used in more than 110,000 American women. Because of concerns about possible toxicity, they were withdrawn from the US market in 1991. These implants remain popular in many parts of the world.

[OBJECTIVE] The goal of this study was to evaluate long-term experience with polyurethane foam-covered implants and compare outcomes and complication rates with other types of implants.

[METHODS] This population-based study was comprised of all individuals receiving either polyurethane breast implants (n = 568) or other types of silicone gel-filled breast implants (n = 963) for augmentation, reconstruction, or secondary revision surgery between 1981 and 2004 (23 years). A prospective implant database was established and maintained in Microsoft Excel (Redmond, WA). Data were extracted from chart review and questionnaires mailed to 719 patients (response rate, 48%). Various parameters, including infections, hematomas, excessive waviness, capsular contracture, rupture, systemic side effects, reoperation rates, and patient satisfaction were monitored. Statistical analysis was performed using SAS 9.1 (SAS Institute, Cary, NC).

[RESULTS] The incidence of capsular contracture was dramatically lower with polyurethane foam-covered implants compared to smooth or mechanically textured implants; this beneficial effect persisted at least 10 years after implantation. Aside from a transient skin rash, there was no increase in morbidity or complications associated with polyurethane implants.

[CONCLUSIONS] Polyurethane foam-covered implants result in long-term reduction in the risk of capsular contracture and appear to have a safety profile similar to other silicone gel-filled devices.