After becoming aware of the 2,500 transvaginal mesh lawsuits stacking up against medical device manufacturer, Boston Scientific, the California attorney general’s office has launched an investigation of the company’s mesh products, according to a Mass Device report.

The article published Nov. 7 also sheds light on a whistleblower lawsuit that was filed against Boston Scientific’s neuromodulation unit in March 2011, alleging that it ran a scheme to promote off-label use of its Precision Plus spinal cord stimulation system. The case, which was unsealed this past August in the U.S. District Court for New Jersey, contains 29 counts of allegations that Boston Scientific sold the device without certification proving medical necessity.

Diagnostic codes for the Precision Plus system were also fraudulent, lawyers contend, and off-label use of the device was promoted by the company.

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

All transvaginal mesh lawsuits filed in federal court were brought by plaintiffs who experienced mesh erosion, infection, bleeding, chronic pain and other complications after being implanted with Boston Scientific devices. As of late, they have been consolidated and assigned to a single judge in the U.S. District Court for Southern West Virginia.

In citing reasons why plaintiffs have filed suits against their company, 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 who brought the 2,500 cases over their products are also “alleging personal injury associated with use of our transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse,” the company stated.

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

Published November 9, 2012 by