American Medical Systems (AMS), based in Minnesota, is a major manufacturer of transvaginal mesh medical devices, which are support systems designed to correct pelvic organ prolapse, (POP) and stress urinary incontinence (SUI).
Johnson & Johnson is the global leader in prolapse mesh, followed by American Medical Systems, Boston Scientific, and Bard.
Many women have experienced physical problems such as mesh erosion, pain and infection, bleeding, scarring, pain during sexual intercourse, organ perforation and urinary problems that require additional treatment and hospitalization. As well, TVM causes psychological concerns such as sexual and intimacy problems.
As more women are implanted with TVM, complaints are on the rise: Between 2008 and 2010, the FDA received 1,503 reports of injuries or malfunction, a fivefold increase from 2005 to 2007.
Transvaginal Mesh Statistics
In 2010, about 300,000 women in the US had pelvic organ prolapse (POP) surgeries, including more than 70,000 who received vaginal meshes. Approximately185,000 women underwent procedures in which mesh was implanted vaginally to treat stress urinary incontinence (SUI).
By July 2011, the FDA said it had received 2,874 more reports of complications.
The FDA has received a number of adverse reports regarding AMS transvaginal mesh. These reports have resulted in a number of lawsuits filed against the company by women who may have been implanted with the following AMS mesh:
AMS Transvaginal Mesh Adverse Reports
- AMS Apogee Vault Suspension System
- AMS Elevate Prolapse Repair System
- AMS Monarc Sling System
- AMS Perigee System
- AMS Sparc Sling System
In May 2011, AMS signed a research grant to evaluate anatomical, functional and safety outcomes of two different treatments for vaginal prolapse, its goal of the study to more thoroughly address vaginal and lower urinary tract function in addition to safety and efficacy, according to AMS.
In January 2012 an order was issued to AMS and other TVM makers, requiring them to study their products risks in women who are implanted with the surgical mesh for urinary incontinence. AMS will study side effects such as mesh erosion, pain and infection. It must provide data on the effectiveness of transvaginal mesh implants for treating conditions like POP and SUI in women.
TVM attorneys claim that, if clinical studies had been required before transvaginal mesh devices were FDA-approved and implanted in women, these issues may have come to light much sooner for those patients who are now suffering the consequences.
More than 650 lawsuits have been filed against transvaginal mesh manufacturers, including American Medicals Systems, or AMS.
A California woman filed a defective medical device lawsuit against AMS, claiming its transvaginal mesh caused her injuries and health complications from POP surgery in 2009; the AMS lawsuit also claimed that AMS failed to properly warn consumers of the potential risks associated with their transvaginal mesh devices. Teresa Frazier, who filed the lawsuit in December 2011, claims that, after being implanted with a MiniArc transobturator tape urethral sling in September 2008, she experienced recurrent pelvic pain, erosions, and recurrent infection of the tissue around the mesh. Frazier had revision surgery in 2010 but is still suffering from chronic pain and psychological problems.
A recent AMS transvaginal mesh lawsuit in Alabama claims that the AMS mesh Elevate is defective and has caused serious injuries.
Both AMS mesh lawsuits allege that AMS failed to warn patients about the potential side effects, and should be held liable for misrepresentation, negligence, and fraud.
American Medical Systems has filed a motion with the US Judicial Panel on Multidistrict Litigation (MDL) to consolidate all cases for pretrial proceedings on its transvaginal mesh in the US District Court for the Eastern District of Minnesota.
In October 2011 Judge Carol Higbee, who is overseeing the consolidated transvaginal mesh lawsuits, issued a scheduling order for the initial TVM bellwether trials, with the purpose to try cases that are representative of plaintiffs' claims generally and to determine the strength of plaintiffs' claims and the extent of defendants' potential liability. Judge Higbee set a trial date of November 5, 2012 for the first group of transvaginal mesh lawsuits.
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