Health officials in the U.K. are advising surgeons and the public on ways to potentially avoid complications caused by transvaginal mesh surgery devices used to treat women suffering from two serious and common conditions.
According to an update at Public Health Watchdog, a leading source on defective medical devices like transvaginal mesh, officials with the U.K. Health Ministry, the National Health Service, and the Medicines and Healthcare products Regulatory Agency (MHRA) have issued new guidance for surgeons to use transvaginal mesh most effectively to reduce the risk of serious injuries caused by the devices.
Transvaginal mesh has been implicated in tens of thousands of serious injuries to women worldwide and in the U.S., the domestic Food and Drug Administration is currently ordering manufacturers of transvaginal mesh devices to conduct post-market safety testing on their products to ensure they’re safe and effective in the treatment of pelvic organ prolapse and stress urinary incontinence as their manufacturers claimed when they were first approved for use.
In the wake of that decision, several manufacturers have removed their devices from the market but they’ll still be required to conducts those studies to serve the many people who still rely on them for the treatment of those conditions. That’s one of many reasons why the foreign health services have issued updated guidelines aimed at reducing the risk of injuries when a transvaginal mesh device is used again in future surgeries. Earlier this year, the FDA issued an update on transvaginal mesh injuries and warned women and the public that complications caused by these devices were indeed “not rare” and posed a significant risk of injury, especially based on the data currently available.
In the U.K., at least 15 percent of women who’ve received a transvaginal mesh device have experienced complications that have led to serious injuries and the need for several follow-up surgeries to correct these problems. For many women, these corrective surgeries come at a high cost, are painful, and not often fully successful, warranting more surgeries to either correct or remove a defective device.
A statement from the Health Ministry adds, “These measures will include developing proposals for a registry for implanted vaginal tapes and meshes to help surgeons to compare the outcomes of their treatment, building on the voluntary registries already established by the professional associations.”
An official with U.K.’s National Health Service said his agency is working with victims of transvaginal mesh injuries to effectively combat these complications and determine the best course of action for future reported injuries caused by transvaginal mesh devices.
