For more than 10 years Cook Biotech, Inc., has marketed and sold vaginal mesh and pelvic mesh products for the treatment of pelvic organ prolapse and stress urinary incontinence. These products include: Surgisis Biodesign Anterior Pelvic Floor Grafts, Surgisis Biodesign Posterior Pelvic Floor Grafts, Surgisis Biodesign Vaginal Erosion Repair Graft, Surgisis Biodesign Urethral Sling and Surgisis Biodesign Tension-Free Urethral Sling.
Cook Medical’s products were derived largely from hernia mesh products. Yet, Cook Biotech has asserted that its Surgisis design is a whole new category in the evolution of tissue repair. Cook referred to its products as breakthrough technology, incorporating the best attributes of biologic graft, resistant to infection and complete remodeling, with the added benefits of moderate price, ease of use and widespread availability.
Cook has further asserted about their Biodesign pelvic mesh products that “unlike synthetic mesh, nothing is left permanently in the body to cause problems down the road.” Despite such claims, on August 20, 2011, Cook issued a communication to the FDA in advance of the September 2011 advisory committee hearings regarding the investigation into the risks associated with mesh for stress urinary incontinence and pelvic floor repair and/or pelvic floor prolapse. In its communication, Cook admitted that “remnants” from the surgery can remain and cause inflammation.
Contrary to Cook’s assertions that its products are resistant to infection, result in complete remodeling, are limited in inflammatory response to areas where synthetic sutures are/were utilized during surgery and will not cause any problems down the road, there have been studies that suggest otherwise.
Our investigation indicates that vaginal mesh implants can cause mesh erosion into the vagina, bladder, colon, intestines and uterus, mesh shrinkage or contraction, mesh migration, mesh exposure, scar tissue formation, granuloma formation, infections, pelvic pain, urinary incontinence and development of urinary retention, dysuria (painful urination), dyspareunia (painful sexual relations), neuropathic pain, fistulas and recurrence of prolapsed organs, often leaving women with worse symptoms and complications than the conditions they were used to treat. These complications have decreased the quality of life many patients once enjoyed.
Our Cook Medical Surgisis Biodesign Attorneys have been actively pursuing and investigating cases involving complications related to Cook Biotech’s products.
Contact our Cook Medical Transvaginal Mesh Attorneys immediately if you or someone you know has had one of these mesh products implanted and experienced similar complications or symptoms.