A leading chemist has suggested vaginal mesh is subject to less vigorous testing than household vacuum cleaners and washing machines.
Vaginal mesh is a synthetic net material, used to strengthen weak connective tissue or ligaments, which are often the result of childbirth. Thousands of women worldwide have reported life-changing complications after having vaginal mesh surgery, with some telling HuffPost UK they have experienced “intense pain” and been forced to give up work.
Speaking about the plastic used in vaginal mesh implants, chartered chemist Dr Chris DeArmitt told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”
[READ MORE: What Is Vaginal Mesh?]
He went on to say the material is not “bio-compatible”, suggesting that the body rejects it.
“It’s like having a splinter. Your body says, ‘Hey there’s a foreign body in here let’s get this out’ and it fights this using different mechanisms, which leads to inflammation and pain,” said Dr DeArmitt.
Joanne Lloyd had vaginal mesh inserted in 2004 designed to treat the stress urinary incontinence she experienced after the birth of her three children. For more than a decade afterwards, she says she experienced pain so intense she was forced to leave her job of 16 years as an NHS receptionist.
“It felt like glass or razor blades inside me. It was just horrendous,” Lloyd, now 53, previously told HuffPost UK. “My whole life changed. We were keen mountain walkers. We went to Glastonbury... I went from being a very sociable person who was always out to being a recluse.”
The use of vaginal mesh was paused last year amid safety concerns, with guidelines saying it should only be used for research purposes.
But in April, NICE released guidelines which said “non-surgical options should be offered before any procedure” and that “there is limited evidence on possible long-term harms of all surgical options.”
Campaigners and patients raised concerns that this would lead to the use of mesh being reinstated. Members of the Independent Medicines and Medical Devices Safety Review also contacted NICE to raise concerns. NICE confirmed that the ‘research only’ restriction still stands and “recognised that the wording of the latest guidelines did not convey this clearly”.
The Independent Medicines and Medical Devices Safety Review, led by Baroness Cumberlege, continues.
HuffPost UK contacted the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical devices in the UK, for comment on vaginal mesh in relation to Dr DeArmitt’s comments.
An MHRA spokesperson said patient safety is their highest priority.
“We always investigate safety concerns with medical devices and we continue to closely monitor the situation with vaginal mesh,” they said.
“While we recognise some patients do develop serious complications, we also know many patients gain benefit from surgical mesh implants for what can be extremely debilitating conditions.”
The decision to use any mesh device should be made between the patient and clinician, after discussing all the options and “recognising the benefits and risks in the context of the distressing conditions being treated”, they added.
The MHRA encourages anyone who is aware of a complication associated with vaginal mesh to report it via the Yellow Card scheme, regardless of how long ago the implant was inserted.