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FDA WARNINGS AND MANUFACTURERS' SELF-INITIATED RECALLS

After hundreds of women reported transvaginal mesh complications, the FDA issued several safety alerts. Details about these warnings and manufacturers' recalls follow.


FDA Safety Alerts Identify Most Frequent Mesh Complications

  • Between 2005 and 2008, the FDA received more than 1,000 reports of serious transvaginal mesh complications. In October 2008, the FDA issued a warning about the increased risks of using transvaginal mesh devices. Some additional factors involved in mesh device complications may include general health, mesh material, a hysterectomy or other procedure during the same operation and estrogen levels.
  • In July 2011, the FDA released another warning about the most frequent mesh complications including mesh erosion through the vagina, extrusion or protrusion. Other problems include pain, infection, bleeding, painful sex, perforated organs and urinary issues. Women also experience neuromuscular issues, mesh shrinkage, scarring, vaginal shortening, sexual dysfunction also occur and recurrences of POP.
  • In early 2012, the FDA informed several mesh manufacturers that further safety testing was required. Specifically, companies needed to assess if mesh products placed patients at increased risk.
  • In 2014, the FDA submitted two proposals to reclassify mesh products as a Class III device. In 2016, the new requirement for careful testing before sales of mesh products was approved.
  • Manufacturers' Self-Initiated Mesh Device Recalls

    As increasing numbers of women filed reports of serious mesh complications, some manufacturers recalled their own products. Some of these incidences included:

  • In 1999, Boston Scientific stopped selling 20,000 of its ProteGen mesh products after 123 problem reports were received.
  • In 2006, Mentor Corporation substituted a new mesh device for its ObTape sling.
  • In 2011, Boston Scientific withdrew its Pinnacle Pelvic Floor Repair kit from the marketplace.
  • In 2012, J&J's Ethicon subsidiary recalled four different Gynecare mesh products and altered the details on other device labels.
  • In 2012, C.R. Bard ended production of the Avaulta Plus device.
  • For more information about filing a mesh lawsuit, contact us for a free, confidential legal consultation.

    Contact Transvaginal Mesh Lawyers for a Free, Confidential Legal Consultation

    Did you decide to have a mesh implantation for POP or SUI because manufacturers marketed these devices as safe? Did you suffer serious mesh complications and injuries, permanently altering your life? For more information about filing a mesh lawsuit, contact us for a free, confidential legal consultation.

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