Temporary Ban on Vaginal Mesh Use in the U.K.

Temporary Ban on Vaginal Mesh Use in the U.K.

Introduction

The U.K. Department of Health and Social Care and National Health Service (NHS) England has decided to halt the use of vaginal mesh for treating stress urinary incontinence, acting on the request put forth by the Independent Medicines and Medical Devices Safety Review on July 10, 2018.

Transvaginal mesh is a surgical net-like implant, manufactured by various companies such as Ethicon, C.R. Bard, American Medical Systems, Boston Scientific, Coloplast, Cook Medical, Neomedic. It is used in the form of a sling to treat stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women since the 1990s. Abdominal hernias have also been treated with a surgical mesh since the 1950s. The insertion of this mesh or a bladder sling through the vagina is known as a transvaginal mesh. The Food and Drug Administration (FDA) approved the first surgical mesh specifically designed for SUI in 1996. Later, in 2004, the FDA approved the first surgical mesh specifically for use in POP.

The temporary ban on the vaginal mesh will stay until March 2019, but the review board asserts that the devices should be back into the UK market only after assuring that a substantial amount of the risks can be curbed. In her press release statement, the review board chairperson Baroness Julia Cumberlege told, “We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively. We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications. I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly.” The ban would be removed after a detailed inspection and accreditation of all specialist centers that conduct stress urinary incontinence mesh procedures.

Transvaginal mesh lawsuits continue to be filed in the U.S. District Courts against manufacturers including Ethicon, C.R. Bard, Boston Scientific over design flaws causing severe internal injuries in several women.  All of the TVM multidistrict litigation in the U.S. over failure to warn allegation is overlooked by Judge Joseph R. Goodwin in the Southern District of West Virginia.