Transvaginal mesh recall and Thomas Plouff Law firm urge women with complications due to vaginal mesh to get help immediately.
The FDA ordered on April 16, 2019, after evaluating premarket approval (PMA) applications. They ordered manufacturers of surgical mesh designed for transvaginal repair of pelvic organ prolapse (specifically Boston Scientific Uphold Lite, Boston Scientific Xenform, and Coloplast Direct Fix Anterior) to stop selling and distributing their products without delay.
Initially, transvaginal mesh was classified as a Class 2 medical device, meaning it was “exempt.” It did not need premarket clearance with the FDA to assess safety and effectiveness.
The FDA, however, tightened its stance on this product in January 2016. A public safety announcement stipulated that all transvaginal mesh products would be reclassified to Class 3, the strictest label of all, and that premarket approval would be required for the products before they could be widely distributed.
It has taken the FDA some time to reach this stage. Although they alerted the public to potential dangers with their vaginal mesh in 2008 and 2011, several women continued to have complications after surgery. Therefore, in 2011, they assembled an advisory council, and in 2012, they issued an order mandating that all product producers engage in postmarket product monitoring.
Many companies relabelled their products, removed them from sale, or even denied that they made transvaginal mesh to avoid this kind of postmarket research.
Is there a recall on bladder mesh?
The FDA has recalled neither the mesh used in POP repair nor the mesh used in mid-urethral sling operations to treat stress urine incontinence. Read more here.
Abdominal mesh repairs for vaginal vault prolapse and stress urinary incontinence continue to be the treatment of choice.
There is strong evidence that the bladder mesh sling is the most effective therapy for stress incontinence. Sling mesh for incontinence is now considered one of the most effective and safe therapies for urinary incontinence. The available data also supports mesh repair using sacrocolpopexy for vaginal vault prolapse.
However, note that the FDA’s ruling doesn’t apply to mesh slings for incontinence and abdominal mesh repairs for pelvic organ prolapse. Those who have mesh for these reasons have no reason to doubt the safety of their operations or to have the mesh removed.
FDA ban on transvaginal mesh: What does it mean for women facing pelvic organ prolapse?
There are still effective surgical treatments for treating POP and incontinence since the FDA restriction solely relates to surgical mesh intended to be used in prolapse repairs. For example:
Stress urinary incontinence has been treated successfully using slings for the bladder or vaginal area since its introduction in the 1990s.
Prolapse correction using laparoscopy involves making five tiny incisions in the patient’s abdomen and inserting a mesh or tissue-based strip to reposition the pelvic organs or vagina.
When repairing a prolapse transvaginally utilizing the patient’s tissue, doctors can lift the prolapsed organs and restore the pelvic organ support without resorting to invasive surgery.
Transvaginal Mesh Recall & Discontinued Products
In 1996, the first mesh product, the ProteGen Sling, was approved by the U.S. Food and Drug Administration to treat SUI. About three years after its first release, Boston Scientific recalled the device.
However, the FDA approved several variations on the ProteGen Sling design before it was taken off the market.
After reclassifying surgical mesh for some transvaginal repairs as “high-risk” medical devices, the FDA has issued safety notifications, established advisory groups, and even forced manufacturers to cease selling the product during the last decade.
As a result of adverse effects such as mesh erosion, organ perforation, and infection, attorneys for more than 100,000 women have filed claims against the producers of transvaginal mesh.
While other producers have stopped making mesh altogether, those companies have issued no recalls.
The use of transvaginal mesh to treat pelvic floor disorders was halted by the Food and Drug Administration in 2019. The FDA reiterated the dangers associated with transvaginal implantation of surgical mesh for treating POP in October 2022.
Companies that Discontinued Mesh Products
Several manufacturers have removed their items off the shelves without filing recalls. Medical equipment is no longer for sale once its manufacturer has withdrawn it.
When a medical device is recalled, the manufacturer must inform patients and doctors of potential dangers and, in most cases, cover the costs of any necessary procedures to remove the device.
Mentor Corp. Pulls Back The ObTape Vaginal Sling, manufactured by ObTape Mentor Corporation: was a mesh device to treat stress urinary incontinence
Mentor got FDA approval for their product by claiming it was similar to the recalled ProteGen Sling from Boston Scientific. This argument was predicated on the fact that the FDA had already approved Johnson & Johnson’s Tension Free Vaginal Tape System.
Between 2003 and 2006, surgeons implanted ObTape before the company voluntarily recalled the device.
Some medical professionals had already ceased prescribing the device due to its high risk of vaginal extrusion before it was pulled off the market. The body rejected it because, according to the experts, it was too thick to enable capillaries and tissue to grow through it.
Withdrawal of Ethicon Mesh Products
The Ethicon division of Johnson & Johnson recalled four Gynecare mesh devices in June 2012.
- Gynecare TVT Secur
- Gynecare Prolift Kit
- Gynecare Prosima Pelvic Floor Repair System Kit
- Gynecare Prolift + M Kit
The manufacturer has ceased distribution of the items internationally, although any already sold or implanted mesh remains in place. The corporation denied that concerns about user safety were behind the decision to stop producing the gadgets.
Although Ethicon has modified the Gynecare Gynemesh label to indicate that it should only be used for abdominal implantation, the product is still available.
Additional recalled products
Rather than update the FDA on the safety of their products, numerous manufacturers have pulled them off the market.
- Surelift Prolapse System
- Mentor Suspend Sling
- Adjust TM Adjustable Single Incision Sling
- Ethicon Gynecare Gynemesh PS Prolene Soft Mesh implants
- AMS Single Incision Sling System
- AMS Apogee and Perigee Systems
- Bard Avaulta Plus Biosynthetic Support System
- Sofradim UGYTEX Dual Knit Mesh
- ECM Surgical Patch
- Sofradim UGYTEX Dual Knit Mesh
- Sofradim UGYTEX Mesh
Law Firm in Chicago, Illinois, Offers Consultations
Thomas Plouff Law firm in Chicago offers women consultations to discuss their options on transvaginal mesh lawsuits. Please get in touch with us immediately for a free consultation if you or a loved one has suffered an injury or loss of life due to a defective transvaginal mesh implant or sling.
Pain and suffering, both past and future, loss of normal life, and wrongful death are only some of the damages that might be discussed during a consultation with an attorney in our elite law firms.
Our global Law Firm has successfully handled injury cases involving transvaginal mesh implants and slings. Our lawyers actively offer legal services to victims in Chicago, Illinois, and the surrounding areas.
Thomas Plouff Law Firms deliver unparalleled service and expertise to our clients and has won or settled more medical device defect lawsuits than any other firm. When it comes to customer service, we are second to none.