Transvaginal Mesh Lawsuit
Transvaginal Mesh Lawsuit | Complications: Erosion and Extrusion of Mesh, Perforation of Organs, Recurrence of Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence, Vaginal Bleeding, Drainage, Scarring, Pain
The leading law firm of Alonso Krangle LLP is currently investigating potential lawsuits on behalf of women injured by transvaginal mesh implants used in the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Thousand of women have already filed lawsuits against the makers of transvaginal surgical mesh, alleging these products caused serious and life-changing injuries including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection and pain.
Transvaginal mesh products currently being investigated by Alonso Krangle LLP include:
- American Medical Systems Transvaginal Mesh Lawsuits
- Boston Scientific Transvaginal Transvaginal Mesh Lawsuits
- C.R. Bard Transvaginal Mesh Lawsuits
- Johnson Johnson / Ethicon Transvaginal Mesh Lawsuits
Transvaginal Mesh Injuries
Transvaginal mesh devices, sometimes referred to as pelvic slings or bladder mesh, are implanted to provide support for a woman’s pelvic organs, which drop, fall, bulge or protrude into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. These products are used to treat two conditions, pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The sling is implanted transvaginally and surgically attached to the vaginal wall. The surgical mesh then acts as a hammock to support the prolapsed organs and to address the symptoms associated with the conditions.
In 2010 alone, more than 100,000 women were treated for POP with surgical mesh implant procedures. It is estimated that roughly 7,000 of these procedures involved transvaginal implantation of a pelvic sling. However, it is becoming increasingly apparent that women treated in this way often suffer serious, life-altering complications, including:
Complications from Transvaginal ( vaginal, prolapse, surgical, pelvic ) mesh failures may include:
- Mesh erosion through the vaginal tissue, may cause the skin to split
- Mesh extrusion and exposure, may require multiple surgeries to fix
- Perforation or puncture of bladder, intestines, bowels, and/or vaginal wall
- Protusion or lump in the vaginal opening
- Recurrence of Pelvic Organ Prolapse (POP)
- Recurrence of Stress Urinary Incontinence (SUI)
- Urinary problems
- Vaginal bleeding, pain and discomfort, chronic drainage, discharge, infections, scarring and/or shrinkage
- Painful sexual intercourse
In July 2011, the FDA issued a Safety Communication warning it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. According to the agency, studies it had reviewed indicated that roughly 10 percent of women who have pelvic slings implanted transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh. However, for many women, even multiple surgeries will not resolve the complications. The FDA also stated that there was no conclusive evidence showing that transvaginally placed mesh in POP repair is more effective than traditional non-mesh repair in all patients with the disorder and that “it may expose patients to greater risk.”
In September 2011, the FDA convened a meeting of its Obstetrics Gynecology (OB/GYN) Medical Device advisory panel. Over the two day meeting, the majority of panelists agreed that the safety, effectiveness and benefit of transvaginal mesh devices in POP repair is not well established and warrants long-term prospective follow-up of patients.
Like many dangerous medical devices, bladder slings used in the transvaginal repair of POP were approved by the FDA through its 510(k) approval process. This more streamlined clearance process allows medical devices to be approved without human clinical trials if it can be shown that the device is “substantially equivalent” to a product already on the market. The FDA has recently proposed reclassifying transvaginal mesh devices used in POP repair, making them ineligible for 510(k) approval. In January 2012, the FDA asked 35 vaginal mesh manufacturers for data on the safety and effectiveness of their transvaginal mesh implants. The FDA also mandated that manufacturers conduct safety studies on transvaginal surgical mesh implants. Unfortunately, the FDA’s action has come too late for the thousands of women who have already sustained painful and debilitating injuries from defective transvaginal mesh devices.
The defective medical device lawyers at Alonso Krangle LLP rank among the nation’s top personal injury lawyers, and are committed to making sure the women injured by transvaginal mesh products receive the justice they deserve. If your life and health were ruined by a transvaginal mesh injury, you deserve compensation for your pain and suffering. While nothing can completely make up for the suffering you’ve experienced, filing a transvaginal mesh lawsuit may enable you to receive compensation for your medical bills, lost wages, pain and suffering, and emotional distress. The defective medical device lawyers at Alonso Krangle LLP are currently offering free lawsuit consultations to women injured as a result of transvaginal surgical mesh implants. To learn more about your legal rights, please contact the transvaginal mesh injury lawyers at Alonso Krangle LLP today.
Learn More About Filing A Transvaginal Mesh Implant Lawsuit
If you or a loved one suffered painful complications, including mesh erosion and extrusion, organ perforation, painful sexual intercourse, vaginal bleeding, or chronic infections following POP or SUI surgery that involved a transvaginal mesh product, you may be eligible to file a personal injury lawsuit against the manufacturers of your implant. To learn more about the legal options available to you, please contact the transvaginal mesh injury lawyers at Alonso Krangle LLP by filling out our online form or calling us.
Alonso Krangle LLP Disturbed by Report that Johnson Johnson Marketed Transvaginal Mesh without FDA Approval