Vaginal mesh problems in UK and USA for J&J

By Dr. Ananya Mandal, MDOct 2 2017

Meshes in the United Kingdom

Vaginal meshes have been used surgically in over 75,000 women in England who undergo surgery to correct stress incontinence and vaginal prolapsed. The surgeries between 2006 and 2016 have used this mesh according to data from the NHS. Experts believe that some of these meshes that have been used have never been clinically tested and this is a disaster waiting to happen.

Reports suggest that one in 15 of these meshes that have been surgically implanted have been removed due to complications. They had been used for a 20 minute surgery that is used to correct stress incontinence and prolapsed that results from childbirth. The basic principle of the surgery is insertion of a polypropylene mesh that would support the vagina and the bladder from sagging. In some women the insertion of this mesh is not successful leading to chronic pain that makes it difficult for them to walk or go about their regular day-to-day activities and also makes sexual intercourse painful. Evidence has shown that the mesh that is supposed to be flexible within the body does not always remain so. It hardens and stiffens and can cut into the neighboring organs such as the bladder causing internal injuries.

One manufacturer is Ethicon, a subsidiary of Johnson & Johnson. At present over 300 women from United Kingdom are moving towards legal action against Johnson & Johnson because of their dissatisfaction and complications that arose from this mesh. David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, called this a “significant medical case” claiming that there could be “billions of pounds” in settlements that could make this the “largest medical case in UK history”. On the other side, a spokesperson for Johnson & Johnson said that this mesh has been through rigorous years of clinical research and said that they are confident of their products and these pelvic mesh devices are being used worldwide without complications.

Johnson & Johnson loses a case to a woman in Pennsylvania

Johnson & Johnson must pay out $57 million in compensation to Ella Ebaugh, 51, who underwent vaginal mesh insertion. This insertion was followed by three surgeries that she had to undergo due to the complications. The mesh had cut into her urethra (tube that carries urine out of the body). This is a serious complication that necessitated a surgical correction.

Ms Ebaugh underwent a surgery to correct urinary incontinence that is seen commonly after childbirth. She had had five deliveries that led to her incontinence. She was fitted with Johnson & Johnson’s Ethicon vaginal mesh. Soon she started developing “excruciating pain” on standing, sitting or performing any activity. She had to undergo three surgeries after the initial one to correct the complications and the mesh had to be removed. Despite the surgeries, part of the mesh still remains within her. Ms Ebaugh was awarded her payout after a jury in Philadelphia voted in her favor stating that Johnson & Johnson had been negligent and the mesh was designed defectively.

There are more than 1,000 lawsuits at present around the world, including the US, the UK and Australia, against Johnson & Johnson from women who have developed complications.

Ethicon plans to appeal the court’s decision. They said in a statement, “We believe the evidence in the Ebaugh trial showed Ethicon’s devices were properly designed.”