AMS Mesh Lawsuit Update
We are still accepting sling and pelvic mesh removal or revision cases
AMS lawsuits are still being filed in courts across the nation after the MDL was closed. We have successfully prosecuted cases for women implanted with transvaginal mesh products since 2011. Women plaintiffs implanted with sling and pelvic mesh products claim that the vaginal mesh devices are defective and cause serious health issues, including:
- Vaginal mesh erosion: This is the most common complication following the use of surgical mesh devices to repair pelvic organ prolapse and stress urinary incontinence. Non-absorbable synthetic surgical mesh, such as that made of polypropylene or polyester, can break down or wear away over time. Part of the mesh may become exposed or protrude through the vagina.
- Erosion of mesh into other organs: Less commonly, the mesh may erode into the urethra, bladder or rectum.
- Vaginal mesh contraction: Shortening or tightening of the mesh over time can cause vaginal shortening, tightening or pain.
- Pain during sexual intercourse
- Urinary problems
- Emotional issues
- Chronic pain
- Organ perforation
- Pelvic nerve damage
Pelvic mesh and bladder sling problems have been reported by major medical clinics for decades. Major medical clinics and university affiliated medical institutions, such as the Cleveland Clinic, have published articles and treatise on the Mesh Problems and Complications
American Medical Systems (AMS)
We are reviewing cases involving AMS products that required surgical revision or removal including:
- SPARC Sling
- Mini-Arc Sling
- Monarc Sling
- Apogee Pelvic Mesh
- Elevate Pelvic Mesh
- Perigee Pelvic Mesh
Contact us now for a free medical legal consultation about your pelvic mesh product at 1-800-814-4540. There are deadlines in each state and hospitals destroy medical records after a certain time period so call us now.
FDA Warnings You May Not Know About
July 2011: An FDA Safety Communication identified concerns and issued new recommendations about the use of surgical mesh for transvaginal repair of Pelvic Organ Prolapse (POP).
September 2011: FDA convened a public meeting of the Obstetrics and Gynecology Devices Panel to discuss the benefits and risks of this use. Subsequently, the FDA issued 131 orders to conduct post market surveillance studies (“522 orders”) to 34 manufacturers of surgical mesh for transvaginal repair of POP. Most manufacturers elected to stop marketing surgical meshfor transvaginal repair of POP after receiving their 522 orders.
January 2016: The FDA completed its reclassification of surgical mesh for transvaginal repair of POP into the highest risk class of devices (class III), which requires premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to stay on the market.
July 5, 2018: This was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal POP repair. Manufacturers that did not file PMAs by this deadline were required to withdraw their products from the market. Those that did file PMAs were allowed to keep their mesh products on the market while the FDA reviewed their PMAs.
February 12, 2019: The FDA convened an advisory committee meeting to share the available evidence and seek expert opinions on how to evaluate the risks and benefits of these devices. The committee evaluated mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices. Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior.
In February 2019, the FDA convened an advisory panel of experts that recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months. The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve Pelvic Organ Prolapse devices. Even though these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow up of the subjects already enrolled in their 522 studies.
In 2019, most of the AMS mesh products had been removed from the market and were no longer being implanted in women. However, thousands of women have the AMS products – Apogee, Perigee, Elevate and MiniArc, Sparc, Monarc Slings – implanted and are still indwelling. Many may experience complications and their surgeons may advise to have the implant surgically removed or revised.
Call us for your free medical legal consultation at 1-800-814-4540 or fill out the Contact Form and tell us about your claim.