Johnson & Johnson Mesh Recall
Johnson & Johnson’s Ethicon Gynecare mesh systems are being voluntarily recalled. The Johnson & Johnson (J&J) Mesh systems have been used to treat female patients who suffer from Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI).
Tuesday, June 5, 2012 Johnson & Johnson’s spokesman Matthew Johnson stated that the company asked the U.S. Food and Drug Administration (FDA) if they could stop the sales of four related transvaginal mesh products within the next 120 days. This time period would allow hospitals and surgeons to find suitable alternatives for the recalled Johnson & Johnson Gynecare Mesh products. The product liability litigation is currently overseen by Judge Carol Higbee of New Jersey Superior Court in Atlantic City and federal Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia, including lawsuits involving Boston Scientific Corp and C.R. Bard Inc.
Transvaginal Mesh Recall is Voluntary by Johnson & Johnson
The mesh recall decision was made by Johnson & Johnson (J&J) to end sales of versions of transvaginal mesh products that were used to decrease the intensive pelvic discomfort of women. Due to hundreds of women filing complaints on the products with The Food and Drug Administration (FDA), the company has moved forward to voluntarily discontinue marketing and sales of transvaginal mesh products. The FDA held an ADCOM meeting in September and subsequently announced that mesh used in pelvic organ prolapse repair needed to be reclassified from a Class II to a Class III device. The FDA ordered further post-market studies on both pelvic organ prolapse mesh and synthetic “mini-slings.”
Letters were sent late Monday, June 4, 2012, to judges overseeing different batches of vaginal mesh recall lawsuits. One was sent to a federal judge presiding over multi-district litigation in federal court in West Virginia and the other to a state judge in New Jersey. “Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time. Ethicon will continue to report adverse events and provide medical communications for these products, consistent with applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold. Ethicon is awaiting written confirmation of that plan”
The decision involves four Gynecare products:
Johnson & Johnson Mesh Recall Side Effect – Bladder Sling Erosion
The most frequently reported problem occurring as result of surgical mesh use for the treatment of pelvic organ prolapse is “bladder sling erosion,” or the erosion of the mesh materials of the sling through the vaginal walls. This painful occurrence is also referred to as mesh extrusion, mesh protrusion, or vaginal mesh exposure. In many cases, transvaginal mesh erosion necessitates further invasive procedures to correct or remove the product. Sometimes, even with multiple surgeries, the problem may never be completely repaired.
Do I have a Johnson & Johnson Mesh Recall Lawsuit?
Patients who are injured as a result of treatment with Johnson & Johnson Mesh products choose to file a lawsuit against the manufacturer of the recalled transvaginal mesh. Filing a lawsuit can help a patient with the medical treatment expenses they may have encountered while trying to treat their vaginal mesh complications. If you were treated with transvaginal mesh and experienced mesh erosion or other complications, contact the Johnson & Johnson Mesh Recall attorney at the Willis Law Firm. We can provide a Johnson & Johnson Mesh Recall Lawsuit Evaluation free of charge or further commitment; Contact Us today. We are now accepting vaginal mesh clients nationwide.