What Happened after the Poly Implant Prothèse Recall? A Prospective Cohort Study of 808 Implants into the Predictive Value of Implant Rupture on Postexchange Complications.

[BACKGROUND] Problems with a variety of breast implants have emerged with consequences for patients' health and safety. The authors' goal was to follow up on their Poly Implant Prothèse patients after their implant exchange.

[METHODS] This single-center, single-surgeon, prospective cohort study lasted from 2012 until 2017. Implant size, implantation interval, surgical details, and complications were registered. The Clavien-Dindo classification was used to grade postoperative complications. Logistic regression was used to investigate whether rupture, interval between implantation and explantation, and new implant size were predictors of postexchange complications.

[RESULTS] The authors explanted 808 implants in 404 patients. The rupture rate was 30.9 percent per patient and 20.2 percent per implant. The capsular contracture rate at the time of exchange was low, with 1.86 percent of implants and 2.7 percent of patients; 97.8 percent of patients elected implant exchange and only 2.2 percent just wanted their implants removed. The mean follow-up after implant exchange was 5.2 years, with the last mandatory outpatient appointment usually being scheduled 6 to 12 months after implant exchange. The authors found that 74 patients (18.3 percent) and 124 implants (15.3 percent) had postexchange complications, the majority of them minor (83 percent Clavien-Dindo grade I). Patients with a ruptured implant at the time of exchange were significantly more likely to develop postexchange complications than were patients without rupture.

[CONCLUSIONS] This is the first study providing such a complete long-term postexchange follow-up of a single surgeon's Poly Implant Prothèse implant cohort. Implant rupture at the time of exchange had a high predictive value for postexchange complications in the authors' series of 808 implants and 404 Poly Implant Prothèse recall patients.

[CLINICAL QUESTION/LEVEL OF EVIDENCE] Therapeutic, IV.