I have an extensive background in synthetic implant materials. My medical device experience dates to 1983 when I developed and brought to manufacture hundreds of surgical suture codes based on synthetic materials. I hold 32 US patents, including 27 in the implant device field, and I have been providing expert support for implant mesh litigation since 2010. I have contributed to the evaluation of implant mesh medical complications since that time. I have also served as the Senior Director of Research and Development for a major surgical supplier.
All implants elicit a foreign body response that varies depending on the individual. Vaginal mesh presents a huge surface area to the patient’s soft tissue in an unstable, two-dimensional configuration. As a result, patients encounter a biological response from the degradation of the mesh resulting in chronic inflammation, adhesions and sclerosis of soft tissue layers, leading to discomfort and pain along with the totally unpredictable shrinkage, migration, and mesh extrusion often resulting in vaginal exposure. My opinion has generally been that these kinds of vaginal mesh complications come from lack of rigorous design considerations in development.