Pharmaceutical

European authorities call for review of transvaginal mesh safety

vaginal mesh sling European authorities call for review of transvaginal mesh safetyEuropean drug and medical device regulators have asked a scientific committee to review the safety of transvaginal mesh devices and whether the risks outweigh the benefits.

The European Commission charged its Scientific Committee on Emerging and Newly Identified Health Risks to conduct the analysis on the surgical mesh products used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence.

The request is based on mounting reports of injuries associated with the devices, which range in severity and include complications such as rejection, tissue erosion, mesh exposure and shrinkage resulting in symptoms such as chronic pain, disability, incontinence, sexual dysfunction, and hemorrhaging. Many women have had to undergo repeated surgeries to remove the devices and some have been left with lifelong complications.

“Current data suggests that the use of mesh in surgery is associated with both benefits and risks but few randomized controlled trials have been published,” the commission said.

The review request follows a 2011 warning issued by the U. S. Food and Drug Administration (FDA) during which the agency stated that it had received more than 1,500 reports of adverse events within the previous three years and that complications were not uncommon. Several manufacturers of the devices face lawsuits for marketing defective devices including Boston Scientific Corp., C. R. Bard Inc., Endo Health Solutions, and Johnson & Johnson’s subsidiary Ethicon.

The European Commission gave the committee until January 2015 to offer its comments and recommendations.

Source: Law360