FDA Warnings

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FDA WARNINGS AFTER INSUFFICIENT TESTING

Under the agency's 510(k) program, transvaginal mesh devices were initially categorized as Class II products. These "fast-track" guidelines simply required manufacturers to show that a new product was similar to one previously approved for sale. As a result, clearance was expedited for the following:

  • In 1996, the FDA approved ProteGen, which Boston Scientific manufactured for the treatment of SUI.
  • In 1998, Johnson & Johnson (J&J) started to advertise Gynecare TVT, another mesh device that was cleared because of its similarity.
  • At one point, nearly 40 companies were producing nearly 100 vaginal mesh products.

  • Transvaginal Mesh Device Recalls

    Despite ongoing reports of serious complications related to mesh devices, the FDA has not issued a recall. Some of the manufacturers, however, withdrew some of their own products from the marketplace. Listed below are some of these examples to better help you understand your case:

  • In 1999, Boston Scientific recalled its ProtoGen mesh implant after receiving 123 reports of vaginal mesh complications. Five hundred lawsuits were filed against the manufacturer, which prompted an FDA investigation.
  • In 2011, Boston Scientific recalled its Pinnacle Pelvic Floor Repair kit because of possible low-tensile strength between the needle and suture. This problem could result in needle detachment during mesh leg placement.
  • In August 2011, Public Citizen spoke out on behalf of consumers, urging the recall of all mesh products with non-absorbable synthetic material. The group insisted that the FDA needed to protect women by eliminating the availability of these high-risk products.
  • In 2012, Johnson & Johnson’s Ethicon subsidiary stopped selling four different Gynecare mesh products and changed the information on labels for other devices.

  • Contact Transvaginal Mesh Lawyers for a Free, Confidential Legal Consultation

    Did you suffer complications after a mesh implantation for POP or SUI? Are you furious because manufacturers did not inform surgeons and patients about all of the potential risks? Contact transvaginal mesh lawyers for a free, confidential consultation.

    Between 2005 and 2008, the FDA received more than 1,000 reports of serious transvaginal mesh complications. In October 2008, the FDA released a safety alert about the increased risks of using transvaginal mesh devices. The agency noted that other factors contributing to mesh device complications may include overall patient health, mesh substance, surgical and other procedures during the same operation, such as a hysterectomy, and estrogen counts.
    In July 2011, the FDA issued a safety alert about the most frequent mesh complications, based on medical studies and nearly 4,000 reports. Women with these implants have experienced mesh erosion through the vagina, extrusion or exposure. They have also suffered pain, infection, bleeding and painful sex as well as punctured organs and urinary problems. Neuromuscular issues, mesh shrinkage, scarring, vaginal shortening and sexual dysfunction also occur, along with repeat incidence of POP. These complications may lead to numerous revision surgeries, which are not always successful. Consequently, the FDA recommended safer options, concluding that transvaginal mesh procedures do not offer better results.

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