Expanded clinical experience with 4DDome(R) composite prosthesis in elective open inguinal herniorrhaphy.

Prosthetic material composition is implicated in the phenomenon of postoperative chronic groin pain that has undermined elective open inguinal herniorrhaphy. Reported herein are our 'all-comers' experiences with a novel dual component mesh (4DDome(R)). A prospective cohort (Phase II) study was performed that involved all patients undergoing elective open inguinal herniorrhaphy during a four-year period. Conventional operative technique was used except for choice of prosthesis. The 4DDome mesh comprises a molded dome-shaped composite (10% polypropylene, 90% poly-L-lactic acid) with a lightweight polypropylene mesh overlay. Short- (1 week) and intermediate-term (18 months) clinical follow-up with examination and symptom questionnaire judged outcome while surgeons rated their approval using a visual analogue scale. One hundred ninety-six patients (mean age, 65.5 years; Mean BMI, 25.5; Mean ASA, 1.8, 178 males) underwent repair of 201 inguinal hernias by six surgeons (three residents). The majority of patients had an indirect hernia (n=119) 93 being combined with a posterior wall defect [Nyhus IIIa], whereas 66 had a direct hernia [Nyhus IIIb], and 11 had a recurrent hernia.) Mean operative time was 44.6 minutes with 92 patients being operated under local anesthesia. Ten patients developed seromas and two had hematomas early postoperatively. Median intermediate-term follow-up is currently 19 (range: 3-72) months for the 147 (75%) patients still available for contact. The incidence of chronic groin pain is 8.8%, whereas there has been one hernia recurrence. Surgeon satisfaction and confidence were high. The 4DDome provides appropriate clinical results and, therefore, appears valid for use in routine practice.