According to a new study, the material commonly used in vaginal mesh implants begins to break down within 60 days of implantation in the pelvis.
Researchers also found particles of polypropylene, a type of thermoplastic material, in the tissue around implant sites.
Campaigners called for ‘immediate action’ from the medical community and regulators on the findings ‘to ensure no more lives are destroyed by this dangerous product’.
Transvaginal mesh implants (TVM) – made from synthetic materials such as polypropylene – have been used to treat pelvic organ prolapse and stress urinary incontinence, but can cause disabling damage in some women.
Side effects include infection, pelvic pain, difficulty urinating, pain during sex, and incontinence.
Campaigners called for ‘immediate action’ from the medical community and regulators (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 and limited practice programme.
The research from scientists at the University of Sheffield looked at polypropylene mesh implanted in sheep, which share similar pelvic anatomy to women.
They found that within 60 days the fibers began to break down, becoming stiffer and showing signs of oxidation, a process that progressively worsened over time.
Researchers also discovered polypropylene particles in the tissue surrounding the implant site.
According to the study, the concentration of these particles was ten times higher after 180 days than after 60 days.
Sheila MacNeil, Emeritus Professor of Biomaterials and Tissue Engineering at the University of Sheffield, said: ‘This study provides objective physical evidence that this material does not cope well with implantation in the pelvis.
‘This is crucial because it is imperative that we develop new and better materials for the many thousands of patients suffering 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 defects in materials, rather than trying untested materials on patients.’
The study, published in the Journal of the Mechanical Behavior of Biomedical Materials, suggests that polypropylene surgical mesh “has not been tested for suitability at the implant site,” but rather “an assumption has been made based on the success of polypropylene mesh used to treat abdominal hernias’. that the same mesh would work just as well in the pelvic floor’.
Researchers also discovered polypropylene particles in the tissue surrounding the implant site (stock photo)
Side effects include 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 were awarded payouts as part of a class settlement.
Study leader Dr Nicholas Farr, Research Associate at the University of Sheffield, added: ‘Our results provide strong evidence of the instability of polypropylene and provide new insights into the mechanisms that contribute to its breakdown in the body.
‘While the recent monetary compensation for affected patients is undoubtedly a welcome development, there remains an urgent clinical need for safer materials to address pelvic organ prolapse.
‘I hope that the insights from this research 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 around the world, said the findings “provide yet more damning evidence about the dangers of polypropylene mesh.”
“The community with mesh injuries have endured debilitating complications, unaware that the plastic material implanted in their bodies is not fit for purpose and can break down so quickly,” she said.
‘This study confirms what many of us already suspected: that the network becomes unstable and causes damage that is irreversible.
‘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 familiar native tissue methods to repair prolapse and stress incontinence – without plastic gauze.
‘Patients deserve better. We must prevent further suffering.”
Ms Samson, a former journalist and mother of two from Cambridgeshire, added: ‘The mesh community trusted their treatment was safe but were left to deal with chronic pain, infections, loss of mobility, autoimmune diseases and even organ damage and organ removal where the plastic material has become brittle and acts like an internal blade cutting into tissues and nerves,” she added.
‘It is completely unacceptable that so many have not been informed of these risks.
“The medical community and regulators must take immediate action based on this research to ensure no more lives are destroyed by this dangerous product.”
Dr. Alison Cave, chief safety officer at the Medicines and Healthcare products Regulatory Agency (MHRA), said: ‘Patient safety is our top priority and the use of surgical mesh for the treatment of stress urinary incontinence and pelvic organ prolapse has been restricted since July. 10 2018.
‘Exceptions are made in cases where this type of mesh is the only treatment option suitable for a woman.
‘However, it should only be used in carefully selected patients who have been informed and understand the benefits and risks and in whom all other treatment options have been explored.’