[Outcome at 18 months after the recall of Poly Implant Prosthesis. Experience of a cancer center]

Abstract

Introduction: On March 30, 2010, AFSSAPS (sanitary French) issued a medical alert about breast implants "Poly Implant Prothese" (PIP), because it was shown that its failure rate was higher than of other manufacturers. This alert was accompanied by a suspension of sales and use of breast implants PIP. Since the announcement of this decision, the Institut Claudius Regaud (ICR) has set up a crisis unit to best meet the demands and questions concerning patients who had PIP implants. After 18 months of the beginning of the crisis, we decided to review the consequences of this decision.

Patients and methods: This is a retrospective study of all patients who underwent breast reconstruction with a prosthesis PIP since 2006. We are interested in managing of the crisis, the fate of patients and the problems of implants.

Results: In total 128 PIP prostheses were implanted on 116 patients. These were all cases of asymmetric anatomic implants placed in 91 cases in immediate breast reconstruction and of breast-delayed reconstruction in 25 cases. Twelve patients had a contralateral PIP prosthesis. After careful analysis of the records, we found that 18 patients (16%) had received a change of prosthesis or simple removal of the prosthesis before the beginning of the crisis. No prosthesis was broken. After the retrospective chart review we found that we reoperated 61,2% of patients and explanted 59,4% of prostheses PIP. In 31 cases (26,7%), another surgery was associated with the change of prosthesis. Of the 76 explanted prostheses, ten of them had an abnormality (13,1%). Three implants (3,9%) were ripted. Six implants (7,9%) had a phenomenon of perspiration. The average life span of these prostheses was of 21,3 months. Among patients who were reoperated, we observed three postoperative complications (3,9%).

Conclusion: More than 18 months after the withdrawal on the market of breast implants PIP, we reviewed almost all patients implanted at our institution. To date, 60% of patients no longer have this prosthesis in place, but 16% of patients with this specific breast implant had already been remove before March 2010. Eighteen percent of implants had an abnormality and three had a rupture. In this retrospective study we also found that the care of our patients could be improved, including the legibility of the monitoring and in the administrative field.