Transvaginal mesh devices, which are used to treat stress urinary incontinence and pelvic organ prolapse (POP), have caused thousands of women to suffer and have even been linked to the tragic deaths of several women. Many manufacturers produce surgical mesh products, including Ethicon (subsidiary of Johnson & Johnson), Tyco Healthcare, Bard, American Medical Systems, and Boston Scientific.
1970’s – Adaptation of Surgical Mesh
Surgeons have used surgical mesh for hernia repair since the 1950’s, but it wasn’t until the 1970’s that surgeons began to modify surgical mesh for use in abdominal procedures to correct POP. By the 1990’s, surgeons were using surgical mesh to treat both POP and stress urinary incontinence and were inserting the mesh vaginally.
1996 – First FDA Approved Transvaginal Mesh Product Introduced
In 1996, the Food and Drug Administration (FDA) approved the first transvaginal mesh product. The product was called ProteGen vaginal cling and it was manufactured by Boston Scientific to treat stress urinary incontinence only.
1998 – Johnson & Johnson Introduces Transvaginal Mesh Product to the Market
In 1998, Johnson & Johnson was able to win FDA approval for its Gynecare TVT vaginal mesh sling without conducting rigorous tests or clinical studies. The FDA approved Johnson & Johnson’s vaginal mesh sling only because it closely resembled Boston Scientific’s ProteGen vaginal sling. Other surgical mesh manufacturers were also able to win FDA approval solely because of their products’ similarities to Boston Scientific’s ProteGen surgical mesh device.
1999 – Boston Scientific Recall
In January 1999, after receiving more than a 100 reports of complications, Boston Scientific recalls its ProteGen vaginal sling. Despite this recall, other manufacturers of surgical mesh devices continue to produce, market, and sell products modeled after the recalled vaginal sling.
2002 – Surgical Mesh Approved for Treatment of Pelvic Organ Prolapse
In 2002, the FDA approved surgical mesh for the treatment of pelvic organ prolapse. Although increasingly popular for the treatment of POP, stress urinary incontinence, and other similar disorders, complications linked to transvaginal mesh devices are also increasing.
2008 – FDA Warning
Due to more than a thousand reports of complications linked to transvaginal mesh devices, the FDA issued the first of two warnings. According to the FDA, women were experiencing infections, pain, mesh erosion, vaginal scarring, pain during intercourse, and bowel and bladder perforation after undergoing a transvaginal mesh procedure.
2011 – FDA Warning Update
In July 2011, the FDA issued its second warning of the use of surgical mesh for the treatment of stress urinary incontinence and POP. In this warning, the FDA stressed that reports of complications were not rare and that the use of a surgical mesh product increased a women’s risk of injury.
Justice For Victims
If you or someone you know has been harmed by a transvaginal mesh device, please talk to an attorney at the law firm of Estey Bomberger immediately. We are a nationally recognized personal injury law firm with decades of experience representing those harmed by a dangerous or defective product. We are dedicated to helping our clients get the funds they need for medical expenses, lost wages, diminished quality of life, emotional anguish, and physical pain. For a free, private evaluation of your claim, call or email our firm now.