Biomedical Engineering Expert Opines on Faulty Vaginal Mesh Design

This case involves a woman with pelvic organ prolapse who underwent a vaginal mesh implantation. She began to experience intense abdominal pain a few weeks after implantation, and it was discovered that the mesh dislodged from the vaginal wall where it was implanted and eroded into surrounding tissue. An expert in biomedical engineering was required to evaluate the design of this device, to discuss the properties of its synthetic material composition, and to evaluate the degradation of the mesh.

Question(s) For Expert Witness

1. Please describe your biomedical engineering experience with regards to vaginal mesh products.

2. What is your familiarity with the development of vaginal mesh products?

3. What are the potential complications of vaginal mesh products?

Expert Witness Response E-007957

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.