What is transvaginal and what is the mesh patch designed for?
This mesh product was originally approved by the FDA 501(k) approval process program for Boston Scientific to manufacture as Protegen. The mesh would be inserted through the vagina and help permanently treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). It was believed to be the solution that would help solve POP and SUI and help return women suffering with this condition to a normal functioning life.
POP and SUI are caused when a woman’s pelvic muscles weaken secondary to childbirth or other causes. When this occurs, abdominal organs can fall and a woman’s life can be seriously disturbed, surgery required, etc.
Thus, the story of the transvaginal mesh patch began.
• 1996 – FDA approves Protegen
• 1998 – FDA discovers 2/3 of complaints against Boston Scientific related to transvaginal mesh
• 1999 – Boston Scientific recalled Protegen after complaints of pain during intercourse and erosion of vaginal tissue
• 2003 – Undisclosed settlement amounts in 738 lawsuits related to transvaginal mesh for Boston Scientific
• 2007 – FDA besieged with over 1,000 reports regarding signs and symptoms of complications related to transvaginal mesh. Signs and symptoms included: erosion of vaginal tissue, pain, infection, urinary problems, and the recurrence of POP and SUI (which the mesh was supposed to fix).
• 2008 – FDA does not pull the product, but issues warning. Transvaginal mesh may cause rare adverse effects but are potentially serious
• 2010 – Almost 3,000 reports of transvaginal mesh adverse reactions. 7 reports of death. 300,000 women now have mesh implants according to FDA.
• 2011 – FDA recommends transvaginal mesh moved to high-risk classification
o Manufacturers must conduct human studies
o Investigated 110 studies which included data on almost 12,000 women to determine that about 10% of women who had mesh implant for POP repair had occurrence of erosion within 1 year
• 2012 – 35 vaginal mesh manufacturers ordered by FDA to study the complications related to transvaginal mesh products. Because of this C.R. Bard stopped marketing the mesh in the U.S.
• 2013 – With greater than 8,000 transvaginal mesh implant claims in process, the first trial begins. Plaintiff claims 18 surgeries to correct problems associated with Johnson & Johnson’s transvaginal mesh product.
With such rapid, consistent progression from concept to court, the transvaginal mesh will likely hit the law history books this year. Though POP and SUI are surely a problem for those women suffering from these conditions, the “fix” of the transvaginal mesh is truly no “fix” at all.