Material commonly used in vaginal mesh implants begins to degrade within 60 days of being implanted in the pelvis, study reveals

The material commonly used in vaginal mesh implants begins to degrade within 60 days of being implanted in the pelvis, according to a new study.

The researchers also found particles of polypropylene, a type of thermoplastic, in the tissue surrounding the implant sites.

Activists called for “immediate action” by the medical community and regulatory bodies based on the findings “to ensure that no more lives are destroyed by this dangerous product.”

Transvaginal mesh (TVM) implants, made from synthetic materials such as polypropylene, have been used to treat pelvic organ prolapse and stress urinary incontinence, but they can cause debilitating damage in some women.

Side effects include infection, pelvic pain, difficulty urinating, pain during sex, and incontinence.

Activists called for “immediate action” from the medical community and regulatory bodies (stock photo)

Transvaginal mesh (TVM) implants, made from synthetic materials such as polypropylene, have been used to treat pelvic organ prolapse and stress urinary incontinence (stock photo)

The NHS restricted the use of TVM implants in 2018 and they are now only used as a last resort through a high-vigilance restricted practice programme.

The study by scientists at the University of Sheffield looked at polypropylene meshes implanted in sheep, which share a similar pelvic anatomy to women.

They found that the fibers began to degrade within 60 days, becoming stiffer and showing signs of oxidation, a process that increased over time.

The researchers also discovered polypropylene particles in the tissue around the implant site.

The concentration of these particles was 10 times greater after 180 days than at 60 days, according to the study.

Sheila MacNeil, emeritus professor of biomaterials and tissue engineering at the University of Sheffield, said: “This research provides objective physical evidence that this material is not well suited for implantation in the pelvis.

“This is crucial because it is imperative that we develop new and better materials for the many thousands of patients who suffer from stress urinary incontinence and pelvic organ prolapse.

“We now know how to critically assess any problems with new materials before they are implanted in women.

“It is vital to have tests to detect potential failures in materials, rather than testing unproven materials in patients.”

The research, published in the Journal of the Mechanical Behavior of Biomedical Materials, suggests that the polypropylene surgical mesh “was not tested for suitability at the implantation site” but rather “an assumption was made based on the success of the polypropylene mesh used to treat abdominal hernias. that the same mesh would work just as well on the pelvic floor’.

The researchers also discovered polypropylene particles in the tissue around the implant site (stock photo)

Side effects have included infection, pelvic pain, difficulty urinating, pain during sex and incontinence (stock photo)

It comes after more than 100 women in England with complications from vaginal mesh implants received payments as part of a group settlement.

Study leader Dr Nicholas Farr, a researcher at the University of Sheffield, added: “Our results provide strong evidence for the instability of polypropylene and offer new insights into the mechanisms that contribute to its degradation within the body

“While the recent monetary compensation for affected patients is certainly a welcome development, there is still an urgent clinical need for safer materials to address pelvic organ prolapse.

“I hope the insights from this study will be recognized by current and future mesh manufacturers and contribute to the continued development of safer alternatives.”

Kath Sansom, founder of the support group Sling The Mesh, which has almost 11,000 members worldwide, said the findings “provide yet more damning evidence of the dangers of polypropylene mesh”.

“The mesh-injured community has suffered debilitating complications, unaware that the plastic material implanted in their bodies is not fit for purpose and could degrade so quickly,” he said.

“This study confirms what many of us have suspected: that the mesh becomes unstable, causing irreversible damage.

“It is critical that this new research is used to drive immediate changes in medical practice, including the need for surgeons to relearn traditional skills using trusted native tissue methods to address prolapse and stress incontinence, without mesh of plastic

‘Patients deserve better. We must avoid further suffering”.

Mrs Samson, a former journalist and mother-of-two from Cambridgeshire, added: “The mesh community trusted her treatment was safe but she has been left to deal with chronic pain, infections, loss of mobility, autoimmune disease and even organ damage and organ removal where the plastic material has become brittle, acting as an internal knife cutting tissue and nerves,” he added.

“It is completely unacceptable that so many people were not informed of these risks.

“The medical community and regulatory bodies must take immediate action based on this research to ensure that this dangerous product does not destroy more lives.”

Dr Alison Cave, Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), said: “Patient safety is our highest priority and the use of surgical mesh to treat stress urinary incontinence and pelvic organ prolapse is subject to restrictions as of July 10, 2018.

“Exceptions are made in cases where this type of mesh may be the only appropriate treatment option for a woman.

“However, it should only be used in carefully selected patients who have been informed and understand the benefits and risks, and where all other treatment options have been explored.”