Surgical Mesh Investigation
Written by Faith Anderson on March 26, 2014
Attorney General Investigation Launched Over Pelvic Mesh Complications
State attorney generals are investigating claims of fraud involving the sale of potentially defective vaginal mesh devices manufactured by American Medical Systems.
Several states launched an investigation earlier this month into the practices of Endo Health Solutions, the parent company of American Medical Systems, looking for evidence of possible Medicare and Medicaid fraud tied to the company’s pelvic mesh products. In an annual report filed with the Securities and Exchange Commission, Endo revealed that attorney generals from California and several other states have subpoenaed the company as part of an investigation into problems associated with American Medical Systems (AMS) transvaginal mesh devices, which have been tied to reports of serious adverse side effects. If you used a transvaginal mesh device like AMS BioArc or Bard Avaulta mesh, consult a product liability attorney today who has experience handling vaginal mesh cases. You may have grounds to file a lawsuit against the manufacturing company, in order to pursue financial compensation for your injuries and medical bills.
Possible Side Effects of Transvaginal Mesh
The states involved in the investigation appear to be looking for evidence of potential fraud associated with the company overcharging for pelvic mesh products that did not work as they were intended, for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. Despite claims by mesh manufacturing companies that the products are safe and effective for use in treating POP and SUI, mounting research has identified the use of transvaginal mesh devices as a risk factor for life-altering complications, including:
- Erosion of the mesh through the vagina
- Vaginal infection
- Urinary problems
- Vaginal bleeding
- Recurrence of pre-surgery problems (POP or SUI)
- Need for revision surgery
FDA Surgical Mesh Warnings
In July 2011, the U.S. Food and Drug Administration (FDA) issued a warning, notifying consumers and the medical community about at least 2,874 reports of problems with vaginal mesh and bladder sling devices designed to repair POP between January 2008 and December 2010. After reviewing all available evidence, the agency concluded that transvaginal mesh products provide no additional benefits when compared to more traditional surgery to treat pelvic organ prolapse. In 2012, the FDA issued a letter to several pelvic mesh manufacturers, ordering them to conduct additional trials and studies to examine the safety of vaginal mesh, and to establish whether the devices pose an unreasonable risk of injury for women.
Lawsuits Over Vaginal Mesh Complications
Endo and AMS currently face upwards of 15,000 product liability lawsuits filed on behalf of women who allege that they suffered problems when their pelvic mesh eroded through the vagina, causing infections and other serious side effects. Similar complaints have also been brought against other pelvic mesh manufacturers, including Boston Scientific, Johnson & Johnson’s Ethicon subsidiary, C.R. Bard, and Cook Medical, but it is unknown whether these mesh makers will face similar investigations regarding their potentially defective products. If you believe you have been adversely affected by complications of vaginal mesh, our consumer advocates at the Consumer Justice Foundation can put you in touch with a qualified product liability lawyer today. With a knowledgeable vaginal mesh attorney on your side, you can protect your legal rights and seek fair and timely reimbursement for your injuries.