UK Department of Health to Regulate Vaginal Mesh Products Following Increasing Lawsuits
Following the increasing numbers of vaginal mesh lawsuits filed in the U.S. and abroad, the UK Department of Health recently announced its plan to provide surgeons with guidance and support to help minimize vaginal mesh side effects for women being treated for pelvic organ prolapse (POP).
The agency plans to work with National Health Service (NHS) Commissioning Board and the Medicines and Healthcare products Regulatory Agency (MHRA) in order to draft proposals for a vaginal mesh product registry. The registry should help determine which devices cause the most adverse effects and help doctors avoid using them for patients.
Vaginal Mesh Injuries Spurs Vaginal Mesh Lawsuits
Transvaginal mesh is a surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is transvaginally implanted to support the collapse of internal organs, and has been linked to high incidences of adverse effects.
Approximately 8,000 vaginal mesh lawsuits have been filed by women who suffered injuries such as mesh erosion, infection, chronic pain, urinary problems, pain during intercourse, as well as bowel, bladder and blood vessel perforation. The lawsuits allege that svaginal mesh manufacturers, including Johnson & Johnson subsidiary, Ethicon, C.R. Bard Inc., American Medical Systems and Boston Scientific, designed defective products and failed to alert patients about its potential risks.
Vaginal mesh lawsuits have been consolidated into numerous multi-litigations in federal and state courts.
Vaginal Mesh Injuries to be Regulated by UK Agency
Dr. Susanne Ludgate, the Clinical Director for Medical Devices at the MHRA, said: “We listened to and understand the concerns that many women have about vaginal tapes and meshes. That is why we commissioned research to review the available literature on the safety and adverse effects associated with these products.”
The lawyers at Bernstein Liebhard LLP are encouraged to hear about the effort to regulate and help prevent future vaginal mesh injuries.