Caldera Medical Mesh Lawsuit

In Oct. 2008, the FDA warned that it had received 1000 reports from nine separate vaginal mesh manufacturers of complications with mesh products used in the surgical repair of POP and SUI. These complications included, but were not limited to the following:

• Mesh erosion
• Urinary problems
• Pain, including pain during sex
• Recurrence of prolapse or incontinence
• Blood vessel, bladder and bowel perforation during insertion
• Vaginal scarring
• Decrease in quality of life due to complications

Nearly three years after its initial warning about vaginal mesh complications, the FDA updated its safety communication warning that complications associated with the surgical repair of POP with a mesh product are not rare, as it had initially reported.

The agency warned that transvaginal POP repair with a mesh may put patients at a greater risk for complications than other treatments; with this greater exposure comes no evidence of a greater clinical benefit, such as an improved quality of life, according to the FDA.

The FDA found that the number of reports of complications continued to increase since the 3-year period on which it previously reported (2005 to 2007). The agency received an additional 2800 reports of complications associated with mesh products used to repair POP and SUI between Jan. 1, 2008 and Dec. 31, 2010.

While these reports stemmed from a number of vaginal mesh products, it has been alleged that Caldera Medical Inc. knew that their mesh implants exhibited a high rate of failure and complications, which often required additional surgery, and failed to properly warn patients and the medical community about this risk.

If you or a loved one has suffered complications from a vaginal mesh implant, you may have legal recourse against the manufacturer. Hundreds of lawsuits have already been filed on behalf of women who were implanted with transvaginal mesh products, including those manufactured by C.R. Bard, Tyco and Coloplast. To learn more about your eligibility for a Caldera mesh lawsuit, contact our class action attorneys today for a free consultation, offered at no cost and with no obligation.