RESUMO
Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.
RESUMO
OBJECTIVE: The purpose of this study was to evaluate the benefit of Oncoplastic Breast Conserving Surgery (BCS) compared to standard BCS after primary CT, in terms of oncologic safety and cosmetic outcomes. BACKGROUND: The development of new drugs has led to greater use of primary chemotherapy (CT) for bulky breast cancer (BC) and has allowed wider indications for conservative surgery. PATIENTS AND METHODS: We identified 259 patients consecutively treated with BCS for primary BC from January 2002 to November 2010. All patients had undergone Oncoplastic Breast Surgery (OBS) or standard BCS after primary CT. Mastectomy rates, and oncological and cosmetic outcomes were compared. RESULTS: A total of 45 OBS and 214 standard BCS were analyzed. The median tumor size was 40 mm in the two groups (p = 0.66). The median operative specimen volumes were larger in the OBS group than in the standard group (respectively, 180 cm3 and 98 cm3, p < 0.0001). Re-excision (9% vs. 2%) and mastectomy (24% vs. 18%) rates were similar (p = 0.22 and p = 0.30) in the standard BCS group and in the OBS group respectively. At a median follow-up of 46 months, local relapse (p = 0.23) and distant relapse (p = 0.35) rates were similar. CONCLUSION: OBS allows excision of larger volumes of residual tumor after primary CT. OBS outcomes results were similar to those of standard BCS. Oncoplastic Breast Conserving Surgery (BCS) after primary chemotherapy allows wider breast resection than standard BCS. Survival and relapse probabilities are similar in both groups.