Interim study results of Post Market Prospective Study of FORTIVA^®​ 1mm porcine dermis in breast reconstruction

Objective To demonstrate safety and performance of Fortiva^®​ 1mm Tissue Matrix and Fortiva^®​ 1mm Tissue Matrix perforated porcine dermis following breast reconstruction surgery.

Methods This prospective, non-randomized multi-center study in Germany and the United Kingdom has implanted 85 patients who underwent breast reconstrtucion. Patients are implanted and then followed post-operatively at 1 month, 6 months, 12 months and 24 months.

Results Interim data analysis on 85 patients with average total exposure of 25 total months. Average age 47 years, 93.1% of procedures performed epipectoral and 44.6% had neoadjuvant chemotherapy.

Performance is measured by BREAST-Q: For both groups significant improvements were observed in the physical well-being subscale at months 1 and 6 post procedure. Scores improved over time in other subscales. The EQ-5D is also collected with scores improving over time in both groups.

Forty-seven adverse events (AEs) and twenty-nine serious adverse events (SAEs) have been reported. Most AEs occurred between 0–30 days post-procedure (64.5%), The most common device related AE was seroma in 8.2% of the subjects which is an expected outcome following this procedure. One patient (1.2%) has reported capsular contracture at 13 months post procedure. Wound dehiscence and infection were reported in 2 patients (2.4%). Implant loss at 3 months occurred in 3.5% due to wound healing disorder.

Conclusion Final study results will be available when the follow up is completed in 2023. Interim results are showing positive results for safety and performance of the Fortiva^®​ 1mm Tissue Matrix.

Publication History

Article published online:
21 June 2022