Pharmaceutical

Transvaginal mesh maker develops test to gauge device’s effectiveness

A questionnaire for patients who have received surgical mesh to repair a pelvic floor disorder known as pelvic organ prolapse (POP) has been shown to be a valid measurement tool for determining improvement in sexual function, according to research published in The Journal of Sexual Medicine. The study hopes to shed positive light on a device being reviewed because of safety concerns by the Food and Drug Administration (FDA).

POP is a common condition that occurs when the pelvic organs drop, or prolapse, due to childbirth, age or obesity. The condition can cause urinary incontinence, discomfort and pain during sexual intercourse. It is often treated by surgically implanting mesh through the vagina to shore up the prolapsed organ or organs.

The questionnaire, known as the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) was designed to gauge how well the mesh works, and was tested in a prospective, single-arm, 12-month study to evaluate the effect on sexual function of the surgical placement of a transvaginal, partially absorbable mesh system for the treatment of POP. The results using the PISQ-12 were compared with those of other measures, including the Pelvic Organ Prolapse Quantification, Patient Global Impressions of Change, Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and Surgical Satisfaction Questionnaire.

Researchers found that, at one year, scores were significantly improved as measured by the PISQ-12, and that the questionnaire proved to be reliable, valid, and responsive while displaying good internal consistency. However, several authors of the study were employed by or had financial ties to Ethicon, Inc., a medical device company that manufactures transvaginal mesh used to treat pelvic floor disorders.

The surgical mesh, known for this application as transvaginal mesh, has come under fire in recent years for causing serious injuries, including pain and urinary incontinence. Between 2008 and 2010, the FDA received 1,503 adverse event reports associated with the mesh when used for POP repair – five times more than what had been reported between 2005 and 2007.

Late last year, the FDA conducted a review of the safety of the surgical mesh and fell short of banning the device, opting instead to recommend stronger oversight for transvaginal mesh products seeking approval. The FDA does not always follow the advice of its expert panels, but it usually does. The FDA has yet to announce a ruling on the devices.

Source: Doctors Lounge