Poly-4-Hydroxybutyrate in the Secondary Breast Implant Patient: Outcome Analysis of 486 Consecutive Procedures
A significant number of patients who have undergone breast augmentation require a secondary implant procedure to correct implant or soft tissue-related complications. The efficacy of synthetic absorbable mesh (GalaFLEX, Galatea Surgical, BD, Franklin Lakes, NJ, poly-4-hydroxybutyrate, P4HB) to provide internal support for the breast implant and parenchyma in primary and secondary implant procedures has been reported in the literature. However, there are limited studies examining the long-term effectiveness in secondary breast implant patients. The purpose of this study was to evaluate the safety and efficacy of P4HB mesh in secondary breast implant procedures by analyzing long-term complication and reoperation rates and patient satisfaction.
Methods/Technique: s:
A retrospective review was conducted of 486 consecutive secondary breast implant procedures with P4HB scaffold (n=267 patients) performed by a single surgeon from May 2018 to June 2023. All patients had previously undergone breast augmentation or augmentation-mastopexy. All patients underwent a breast implant exchange with P4HB scaffold coverage. Inclusion criteria included a minimum follow-up of 6 months and an anonymously reported practice-generated patient satisfaction questionnaire administered 6 months postoperatively. Demographics and clinical outcomes, including breast implant specifications, indications for breast implant replacement, surgical technique, and post-operative complications were analyzed
Results/Complications:
The mean follow-up was 25 months (range 7 months to 43 months). Mean age of our cohort was 43 years (25 – 70 years) with a mean body mass index of 24.4 kg/m2 (19-32 kg/m2). Primary preoperative indications for breast implant replacement were breast ptosis (n=126), implant malposition (inferior, lateral, medial) (n=49), desire to change implant size (n=34), capsular contracture (n=49), and animation deformity (n=9). Mean time from primary implant surgery to secondary procedure was 5.7 years (10 months to 22 years). Breast implant exchange was bilateral in 96.3% (n=257) and performed with simultaneous mastopexy in 58.8% (n=157), capsulorrhapy in 30.7% (n=82), and capsulectomy in 22.1% (n=59). Silicone implants were utilized in all patients with a mean fill volume of 380cc (range 225cc-600cc) placed in the submuscular or dual plane in 92.5% (n=247). Overall complication rate for all procedures was 6.4% (n=16) with a reoperation rate of 3.4% (n=9). Tissue-related complications occurred in 3.7% (n=10), most commonly recurrent ptosis or pseudoptosis in 1.9% (n=5), and palpability of the scaffold 1.1% (n=3) implant-related complications occurred in 2.7% (n=6), capsular contracture (Baker III or IV) 1.5% (n=4) and superior malposition 0.75% (n=2). The most common indications for reoperation were recurrent ptosis in 2.1% (n= 2), capsular contracture 1.5% (n=4), and implant malposition in 0.75% (n=2) and 3 (1.1%) patients having a secondary procedure to change implant size. No patient required surgery to remove P4HB mesh. There were no cases of peri-prosthetic infection requiring explantation, no seroma formation, no significant skin flap necrosis (>2cm diameter). Regarding patient satisfaction, 97% (n=259) of patients were satisfied or extremely satisfied with the overall appearance of their breasts, including breast shape, size, and symmetry.
Conclusion: s:
This study further validates the safety and efficacy of P4HB scaffold in revision breast implant surgery. Use of P4HB in complicated breast implant procedures is defined by a low complication rate, acceptable aesthetic results, and a reduced number of operations for the patient with high patient satisfaction. An individualized, patient-centric, approach based on a tissue-based assessment potential for soft tissue stretch should be employed for optimal results.