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Many women over the last decade have undergone procedures that utilize pelvic mesh implants or devices to treat hernias, incontinence, and pelvic organ prolapse (POP). Unfortunately, many of these patients were never appropriately apprised of the potential dangers involved with the use of these devices. The complications that have been reported include, but are not limited to, severe pain, infections, bleeding, and subsequent hospitalization and surgeries.
Initially designed for the treatment of hernias, pelvic mesh implants were approved by the FDA for use in POP in the 1970s. In 1996, the FDA approved the device for use as a transvaginal (through the vagina) implant to treat stress urinary incontinence in women. However, when surgeons opened the door to using the device transvaginally, they also opened the door to a range of potential complications and lasting problems for their patients.
What is Pelvic Mesh?
What exactly is a pelvic mesh implant and how does it work? When inserted abdominally for treatment of hernias, the implant has had a high success rate. It is used to reinforce the muscles around the area of the hernia to prevent the hernia from recurring. When inserted transvaginally, the pelvic mesh is attached to ligaments or muscles with anchoring devices. It is intended to reinforce the weakened vaginal wall in order to repair POP or to support the urethra in treating incontinence.
The mesh, which is made of either porous absorbable or non-absorbable synthetic material, operates as a hammock to support drooping organs. As time passes, the mesh becomes one with the patient as her tissue grows and fills in the pores of the mesh, stabilizing it.
Pelvic Mesh Side Effects
In October 2008, after receiving over one thousand reports of complications from nine manufacturers, the FDA issued a Public Health Notification on serious health complications associated with transvaginal placement of pelvic mesh devices.
In July 2011, the FDA issued an update to that notification after conducting its own review of the available evidence, stating that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.”
The review also revealed the significant problems with the mesh: transvaginal mesh used to correct POP introduces risks to the patient that she would otherwise not face with non-mesh treatment. Transvaginal pelvic mesh may go through mesh contraction, a shrinkage that can cause vaginal tightening and vaginal pain. Transvaginal mesh may also erode the tissues surrounding it.
The erosion of the transvaginal pelvic mesh is the most common and consistently reported complication with the device in POP surgeries and may require multiple surgeries with no guarantee of resolution. Additionally, the pelvic mesh potentially causes painful intercourse — not just for the women, but for their partners as well when they come in contact with the mesh.
Pelvic Mesh Litigation
As a result of the many complications caused by transvaginal pelvic mesh devices, a number of injured women have filed lawsuits.
The first lawsuit was filed by Judy Conlin and her husband, Timothy. They asserted claims against Boston Scientific and Ethicon, two different manufacturers of the mesh product that had been implanted in Judy in July 2011 for POP and incontinence. They alleged failure to warn on the part of the manufacturers, as well as fraud and concealment of permanent and debilitating injuries.
Today, there are more than 55,000 cases pending in the United States District Court of the Southern District of West Virginia as multi-district litigation (MDL), along with in other federal and state courts. The following is a list of the MDL cases overseen by Judge Joseph R. Goodwin in the West Virginia MDL:
Additionally, in New Jersey, there is a mass tort Multi-County Litigation (MCL) pending before the New Jersey Superior Court that involves thousands of suits. Most recently, in October 2017, the U.S. Supreme Court refused to hear an appeal from Johnson & Johnson in a $3.27 million verdict involving its Ethicon subsidiary’s pelvic mesh device. That case, involving the Tension-Free Vaginal Tape-Obturator (TVT-O), was initially decided in September 2014 as part of the second bellwether trial in West Virginia.
Many of these suits accuse pelvic mesh manufacturers of intentionally misleading healthcare providers, patients, and the public about the safety of the device. They also assert failure to conduct appropriate testing and research as well as failing to establish safe and effective methods of removal of the transvaginal mesh.
In cases where women have undergone multiple revision surgeries, some have received millions of dollars of compensation, including a $73.5 million award for a Texas woman who can no longer sit or walk without severe pain.
Contact an Ohio Pelvic Mesh Attorney
If you believe you have suffered damages and/or injuries as a result of a pelvic mesh implant, contact us today for a free case evaluation and consultation with one of our experienced pelvic mesh attorneys. You should obtain any pertinent medical, insurance, and billing records associated with your procedure and treatment as soon as possible and keep a log of dates and events related to any complications.
Taking these important steps early on can make your legal journey much easier and more effective. If you live in Ohio, Kentucky, or Indiana, we are standing by and ready to help.