Close Menu

AMS Mesh Lawsuit Update

We are accepting AMS removal or revision cases involving Apogee, Perigee, Elevate, MiniArc, Sparc, Monarc, IntePro Y. 

American Medical Systems Inc. settled or dismissed cases filed in the MDL court. The AMS MDL closed on March 31, 2021. There were 21,315 filed cases and 21,035 cases were closed. Plaintiffs in those suits claimed that the vaginal mesh devices are defective and have caused chronic pain, fistulas, organ perforation, incontinence and other serious injuries. Many of the implants are no longer on the market and are not being sold: Apogee, Perigee, Elevate and MiniArc, Sparc, Monarc Slings.

  Mesh Problems and Complications

Pelvic mesh and bladder sling problems have been detailed by major medical clinics for decades, yet the mesh and slings still remain on the market and are being implanted in women. Major medical clinics and university affiliated medical institutions, such as the Cleveland Clinic, have published articles and treatise on the mesh complications.

Pelvic Mesh Claims

From 2011 to the present, over 100,000 pelvic mesh claims of defective products causing injuries have been resolved. Settlements and verdicts involving multimillions have been made with many pelvic mesh products taken off the market. We are accepting cases of certain defective pelvic mesh products.

page1image1578272 page1image1584512 page1image1584928 page1image1583888 page1image1584304 page1image1580976 page1image1583472

American Medical Systems (AMS)

Sparc, Mini-Arc, Monarc, Apogee, Elevate, Perigee

AMS products no longer on the market

  • SPARC Sling
  • Mini-Arc. Sling
  • Monarc Sling
  • Apogee Pelvic Mesh
  • Elevate Pelvic Mesh
  • Perigee Pelvic Mesh

Johnson & Johnson/Ethicon

Gynecare TVT, Abbrevo, Exact, Secur, Prolift, Prosima

  • Retropubic Sling
  • Mid Urethral Sling
  • Exact TVT Sling
  • Secure Sling
  • Gynecare TVT
  • Abbrevo TVT Sling

Ethicon Products no longer on the market

  • Gynecare Abbrevo TVT
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch
  • Exact TVT Sling
  • Secur
  • Prolift+
  • Prolift +M
  • Prosima

Bard

Avaulta, Align, Pelvicol, Pelvitex

Bard Products no longer on the market

  • Avaulta PlusTM
  • BioSynthetic Support System
  • Avaulta Solo Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex Polypropylene Mesh

Boston Scientific

Advantage, Obtryx, Solyx, Lynx, Uphold, Pinnacle, Prefix

  • Advantage™ Mid-Urethral Sling System
  • Obtryx® Transobturator Mid-Urethral Sling System
  • Solyx

Boston Scientific Products no longer on the market

  • Lynx
  • Prefyx Mid UTM Mesh Sling System
  • Prefyx PPSTM System
  • Pinnacle® Anterior-Apical Pelvic Floor Repair Kit
  • Pinnacle® Posterior Pelvic Floor Repair Kit
  • Pinnacle® Duet Pelvic Floor Repair Kit – Boston Scientific Uphold Vaginal Support System
  • Uphold

Coloplast

Altis, Aris, Supris, Retorelle Y Mesh

  • Altis
  • Aris
  • Supris
  • Restorelle Y Mesh
  • Restorelle Flat Mesh
  • Restorelle L Mesh

page11image3618000 page11image3618416 page11image3618624page11image3618832 page11image3619040

Contact us now about your pelvic mesh product at 1-800-814-4540.

Consultations are free and confidential. Hospitals destroy medical records containing the name of the pelvic mesh products and there are statutes of limitations in each state, so contact 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 advise to have the implant surgically removed or revised.

Contact Us for a Free Consultation

Contact us should you need medical legal assistance. Our initial consultation is free and confidential. Call 1-800-814-4540 or email carolyn@carolynstclair.com.

Time Limit to Make a Claim

Hospitals destroy medical records after a certain number of years and states have time limitations to file a claim. Contact us NOW before your medical records are destroyed or your time to file a claim has run out.

 

Share This Page:
Facebook Twitter LinkedIn