Loncar Lyon Jenkins is currently filing transvaginal mesh lawsuits on behalf of victims
If you or someone you love were among those needlessly injured as a result of transvaginal mesh, you may be eligible for compensation. Loncar Lyon Jenkins is investigating cases in all 50 states. Contact Loncar Lyon Jenkins immediately for a free, confidential case evaluation using the form on the side or by calling toll free at 800.285.4878. Onglyza heart failure lawsuits are being evaluated on a contingency fee basis, meaning you pay nothing unless a recovery is obtained.
JANUARY 19, 2016 TRANSVAGINAL MESH UPDATE
On January 4, 2016 the U.S. Food and Drug Administration (FDA) reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a class II device (moderate-risk) to a class III device (high-risk). This announcement follows on the heels of previous FDA warnings regarding the risks for severe pelvic pain, infection, painful intercourse, bleeding, organ perforation, and urinary problems. The FDA has also issed a second order that will require manufacturers to submit a premarket approval (PMA) application to support the effectiveness and safety of surgical mesh for transvaginal POP repair. Manufacturers have been given 30 months to submit these PMA applications. The PMA application process is the FDA’s most rigorous investigative process where each product will be put under heavy scrutiny. These devices had previously been cleared through the FDA’s 510(k) process whereas manufacturers could bypass clinical trials and rigorous testing. Currently these decisions do not apply to the use of surgical mesh for other medical issues such as stress urinary incontinence.
TRANSVAGINAL MESH LITIGATION
Transvaginal meshes, also known as bladder slings, are medical devices implanted to treat stress urinary incontinence and pelvic organ prolapse. These devices were designed a lifetime but due to high failure rates along with their propensity to erode and cause organ damage, these devices are now having to be surgically removed from patients at abnormally high rate.
Many companies manufacture different transvaginal mesh/bladder sling devices. The meshes used most frequently and most often linked to injuries in women who receive the implanted mesh, are produced by four manufacturers in particular: J&J/Ethicon, Bard, AMS and Boston Scientific. Below you will find information on the transvaginal mesh devices made by each of these companies. All of these devices have caused serious side effects to women that have received them.
Johnson & Johnson
Johnson & Johnson’s Ethicon Women’s Health & Urology division, a New Jersey company, is responsible for manufacturing many transvaginal mesh devices. Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
Bard is another manufacturer of transvaginal mesh patches. This company, based in Georgia, manufactures, distributes, and markets numerous medical devices. Brand names of Bard’s transvaginal mesh patches include:
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems or AMS
SPARC® is a type of transvaginal mesh patch produced by Minnesota-based American Medical Systems. SPARC® is designed to treat stress incontinence.
AMS meshes/slings that Loncar Lyon Jenkins is litigating include:
- MiniArc Sling
- Monarc Hamock
With headquarters in Massachusetts, Boston Scientific, who has been making medical devices for over 25 years, is also responsible for making potentially defective and dangerous transvaginal mesh systems effects, some of which could be potentially fatal. Boston Scientific’s transvaginal mesh patch brands include:
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
Other mesh manufacturers include TSL Laboratories; Coloplast; Cook Medical/Cook Biotech, Desarrollo e Investigacion Medica Aragonesa, SL “DIMA”; Neomedic; and, Sepcialties Remeex.
The most common transvaginal mesh injuries reported are:
- Internal bleeding
- Vaginal scarring
- Vaginal wall narrowing
- Urinary Problems
- Mesh erosion through the vaginal tissues
- Pain during sexual intercourse
- Recurrence of prolapse, incontinence, or both
If you or a loved one were implanted with a transvaginal mesh medical device and have been treated for any of the symptoms above, contact my office as soon as possible at 1.800.285.4878, or use one of the options on the right to speak with a member of our Mass Torts staff.