Preliminary design of a new degradable medical device to prevent the formation and recurrence of intrauterine adhesions.

Intrauterine adhesions lead to partial or complete obliteration of the uterine cavity and have life-changing consequences for women. The leading cause of adhesions is believed to be loss of stroma resulting from trauma to the endometrium after surgery. Adhesions are formed when lost stroma is replaced by fibrous tissue that join the uterine walls. Few effective intrauterine anti-adhesion barriers for gynecological surgery exist. We designed a degradable anti-adhesion medical device prototype to prevent adhesion formation and recurrence and restore uterine morphology. We focused on ideal degradation time for complete uterine re-epithelialization for optimal anti-adhesion effect and clinical usability. We developed a triblock copolymer prototype [poly(lactide) combined with high molecular mass poly(ethylene oxide)]. Comparative pre-clinical studies demonstrated in vivo anti-adhesion efficacy. Ease of introduction and optimal deployment in a human uterus confirmed clinical usability. This article provides preliminary data to develop an intrauterine medical device and conduct a clinical trial.
Competing Interests: Competing interestsX.G., S.L., S.H., V.L, J.C., and C.P. declare no competing financial interests but the following competing non-financial interests: the authors (X.G., S.L., S.H., V.L, J.C., and C.P.), the University of Montpellier, CNRS, and the University Hospital of Nîmes applied for a patent in 2014 for the polymers and their applications in gynecology. The patent application number is WO201602061. Our patent application is currently being evaluated and expected to have a response by the end of 2020. Two of the authors (S.H. and X.G.) have developed a start-up based on the results of the current study, and one of the authors (S.L.) is currently employed in this new company. L.A, S.W., I.L., A.B., H.T., and R.DeT. declare no competing financial and non-financial interests.