Transvaginal Mesh Manufacturer Under Investigation, Whistleblower Lawsuit Revealed


The California attorney general’s office has launched an investigation into Boston Scientific’s transvaginal mesh devices, after becoming aware of the 2,500 transvaginal mesh lawsuits filed against the device manufacturer.

A November 7 Mass Devices report also reveals a whistleblower lawsuit filed against Boston Scientific’s neuromodulation unit in March 2011. The lawsuit alleged that the company ran a scheme to promote off-label use of its Precision Plus spinal cord stimulation system. The case contains 29 allegations against Boston Scientific, claiming that the company sold the device without certification that proved medical necessity.

The case came into light in the U.S. District Court for New Jersey this August. Lawyers contend that the company promoted off-label use of the device. In addition, lawyers allege that the diagnostic codes for the Precision Plus system were fraudulent.

The Precision Plus was used to treat phantom leg pain and stress urinary incontinence (SUI). According to court documents, Boston Scientific admits these claims prompted “several other attorneys generals offices” to “initiate a civil investigation into [its] sales of transvaginal surgical mesh products.”

The transvaginal mesh lawsuits in federal court were filed by patients who received a vaginal mesh implant from Boston Scientific and suffered mesh injuries, including erosion, infection, bleeding, chronic pain and other complications. The vaginal mesh lawsuits have been consolidated into a multidistrict litigation before a judge in the U.S. District Court for Southern West Virginia.

Officials for Boston Scientific said in a statement: “Generally, the plaintiffs allege design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims.”

Patients filing transvaginal mesh lawsuits also are “alleging personal injury associated with use of our transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse.”

Trial dates for the transvaginal mesh lawsuits filed against Boston Scientific have yet to be scheduled.

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