Surgical safety and efficacy outcomes are no worse after pelvic organ prolapse procedures involving self-cut mesh versus commercial pre-cut mesh kits, Chinese investigators report.
Investigators randomly assigned 336 women with severe pelvic organ prolapse (mean age 63.3 years) to transvaginal implantation of titanium-coated polypropylene mesh that was self-cut or precut in a commercial mesh-kit.
The composite surgical success rate at 12 months was noninferior between groups: 95.9% for the self-cut mesh group vs 87.4% for the mesh-kit group, Lan Zhu, MD, of Peking Union Medical College Hospital in Beijing, China, and colleagues reported in JAMA Network Open. Success was defined as the absence of vaginal bulge symptoms, additional retreatment for pelvic organ prolapse, and vaginal prolapse at or below the hymen.
The Clavien-Dindo grade 1 to 3 complication rate did not differ significantly between groups (7.2% in the self-cut mesh group vs 12.4% of the mesh-kit group). Vaginal mesh exposure rates at 12 months also did not differ markedly between groups: 2.4% of the self-cut mesh group vs 4.8% of the mesh-kit group. De novo chronic pelvic pain occurred in 0.6% vs 1.2%, respectively. Infection requiring antibiotics occurred in 0.6% vs 3.1%, respectively.
Median hospitalization costs were significantly lower for the self-cut mesh group: $3663 vs $6144, respectively, a 40.4% difference.
According to Dr Zhu’s team, the use of self-cut mesh procedures may be advantageous for the surgical treatment of some women with severe pelvic organ prolapse.
The US Food and Drug Administration ordered manufacturers of transvaginal mesh kits to discontinue sales and distribution in 2019. Mesh procedures continue to be performed in Asia and under limited circumstances in Europe.
Chen J, Yu J, Morse A, et al. Effectiveness of self-cut vs mesh-kit titanium-coated polypropylene mesh for transvaginal treatment of severe pelvic organ prolapse: a multicenter randomized noninferiority clinical trial. JAMA Netw Open. Published online on September 16, 2022. doi:10.1001/jamanetworkopen.2022.31869