Vaginal meshes used to treat bladder problems still causing catastrophic problems

Thousands of women worldwide have experienced catastrophic injuries as a result of having a synthetic transvaginal mesh, transvaginal tape, or a bladder sling implanted.

The net-like implant is commonly used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Common side effects reported from the use of the vaginal mesh implants include continuing urinary incontinence; recurrent bladder infections; erosion; haematomas; nerve damage; inability to have sexual intercourse; pain during sexual intercourse; auto immune reactions; and life-long disabilities and even death.

A high-risk medical device?

A number of regulators worldwide have flagged concerns over the use of such devices. They are still in use here in the UK, although some Trusts don’t use them because of the dangers and problems that have been highlighted over the last few years.

Corrective surgery

In many cases, women with the vaginal mesh failures have required multiple complex and corrective surgeries. Even with corrective surgery, some women have reported irreparable and catastrophic injuries that can affect them for the rest of their life.

Worldwide claims

Hundreds of thousands of cases have been launched worldwide against the manufacturers of the medical devices. The Defendants include: Bard Avaulta; American Medical Systems (AMS); Boston Scientific; Johnson and Johnson Ethicon Gynecare; Coloplast; Neomedic; and Cook Surgisis Biodesign.

While most of the vaginal mesh manufacturers have chosen to quietly settle thousands of claims, there are thousands of other claims still left in the balance, and they may easily take years to resolve. This is evidenced by the fact that the vaginal mesh lawsuits have been going on for 7 years as of this year!

U.K. action

The Department of Health, the NHS Commissioning Board, NHS surgeons, and the MHRA are taking action to help reduce the adverse effects caused by the vaginal mesh implants. In 2012, the Department of Health reported that around 13,000 vaginal tape implants are used by women every year in the U.K., and 1,500 women are fitted with vaginal mesh devices. It’s thought that around 150-500 women have suffered severe side effects from the use of vaginal tape, and approximately 200 women have been affected by the use of vaginal mesh implants.

In 2014, The Independent reported that hundreds of Scottish women were left in severe agony after having the vaginal tape or vaginal mesh surgical procedure. Shona Trainer, who had the vaginal mesh implanted in 2011, has had surgery four times to try and remove the implant, which hardened inside her. She reported that the pain was “constant”.

Does the benefit outweigh the risk?

The MHRA – the body responsible for regulating medical devices and drugs in the U.K. – ordered a review of the situation in 2012. The review found that, although some women had adverse effects from the vaginal mesh/tape, it was noted that the benefits of the device outweighed the risks. A key factor identified though was that the skill of the surgeon could easily have a direct link on the success of the surgery, as opposed to the device itself being “defective.”

Some agree that the MHRA may need to review their initial findings give that thousands of women worldwide are suffering serious adverse effects that are in many cases irreversible.

The then Shadow Health Minister, Jackie Baillie, said:

“It’s quite clear this treatment has failed a large number of women. We need an urgent inquiry into the safety of these products.”

She noted that this could be even bigger than the PIP breast implant scandal.