Vaginal mesh: Tests on plastic material 'way less' thorough than on washing machine
A world expert has blasted the use of the plastic mesh in surgeries which have impacted the lives of thousands of women.
Testing on the plastic material used in vaginal mesh implants
"is way less than you would see on a vacuum cleaner or a washing
machine", a world expert has told Sky News.
The use of vaginal mesh to treat incontinence is currently suspended in the UK, pending the results of an independent safety review after thousands of women reported devastating complications.
Chartered chemist Dr Chris DeArmitt has been arguing the material used in the mesh is not safe and his expertise has been called upon during court action against vaginal mesh manufacturers.
His testimony that the polypropylene plastic should not be used inside the body has helped 9,000 women settle out of court.
Dr DeArmitt, who is a consultant to the top technology firms in America, 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."
He believes the material is rejected by the body and the mesh degrades once inside the person, although manufacturers say the material is safe.
He said: "There are two main reasons why any plastics material expert will tell you just obviously that this is a bad material and I have never heard anyone who disagrees with me.
"Firstly, it's oxidatively unstable which means, like an apple, it's attacked by air so it's not going to last long enough in the body. That's knockout criteria right there because it's just going to fail, go brittle and fall into pieces.
"Secondly, it's not bio-compatible. So when it is put into the body, all of your body tries to react. 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."
Polypropylene mesh has been commonly used to treat incontinence and prolapse in women for decades and is used in hernia repair.
While the surgery can be successful, it can also cause life-changing complications including chronic pain. People will react differently to mesh as no immune system is the same and there is a notable lack of long-term studies looking into the problem.
In February 2018, the government announced an independent review into vaginal mesh implants and in July that year the surgery was suspended and a high vigilance period imposed. This development came after the chair of the review, Baroness Cumberlege, had met patient groups and heard their personal accounts.
Dr Vincent Argent, a consultant gynaecologist, is one medical expert who has provided evidence to the Cumberlege review.
:: Vaginal mesh campaigner Chrissy Brajcic dies from sepsis after four-year battle
He said he warned the medical watchdog NICE about the risks of mesh when it was first introduced in the late 1990s but was ignored.
Dr Argent said: "If it was introduced now I don't think it would get a licence. The problem with mesh is the physio chemical changes that it undergoes, which happen over many years, as it has emerged now. This could have been predicted from studies way back in the 1960s and 70s which showed that polypropylene is inherently unstable.
"My opinion is it shouldn't be used in routine clinical practice until there are more clinical trials and more research into the stability of the mesh.
"The surgery does help some people although we do know they could be at risk of long-term complications because mesh erosion does sometimes happen after five, 10 or sometimes 20 years."
The manufacturers of mesh in the UK strongly deny that mesh is
unstable. One manufacturer, Boston Scientific, told Sky News:
"Polypropylene material has been used in medical procedures and by many
device manufacturers for more than 50 years, including in hernia repair
and surgical sutures.The use of vaginal mesh to treat incontinence is currently suspended in the UK, pending the results of an independent safety review after thousands of women reported devastating complications.
Chartered chemist Dr Chris DeArmitt has been arguing the material used in the mesh is not safe and his expertise has been called upon during court action against vaginal mesh manufacturers.
His testimony that the polypropylene plastic should not be used inside the body has helped 9,000 women settle out of court.
Dr DeArmitt, who is a consultant to the top technology firms in America, 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."
He believes the material is rejected by the body and the mesh degrades once inside the person, although manufacturers say the material is safe.
He said: "There are two main reasons why any plastics material expert will tell you just obviously that this is a bad material and I have never heard anyone who disagrees with me.
"Firstly, it's oxidatively unstable which means, like an apple, it's attacked by air so it's not going to last long enough in the body. That's knockout criteria right there because it's just going to fail, go brittle and fall into pieces.
"Secondly, it's not bio-compatible. So when it is put into the body, all of your body tries to react. 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."
Polypropylene mesh has been commonly used to treat incontinence and prolapse in women for decades and is used in hernia repair.
While the surgery can be successful, it can also cause life-changing complications including chronic pain. People will react differently to mesh as no immune system is the same and there is a notable lack of long-term studies looking into the problem.
In February 2018, the government announced an independent review into vaginal mesh implants and in July that year the surgery was suspended and a high vigilance period imposed. This development came after the chair of the review, Baroness Cumberlege, had met patient groups and heard their personal accounts.
Dr Vincent Argent, a consultant gynaecologist, is one medical expert who has provided evidence to the Cumberlege review.
:: Vaginal mesh campaigner Chrissy Brajcic dies from sepsis after four-year battle
He said he warned the medical watchdog NICE about the risks of mesh when it was first introduced in the late 1990s but was ignored.
Dr Argent said: "If it was introduced now I don't think it would get a licence. The problem with mesh is the physio chemical changes that it undergoes, which happen over many years, as it has emerged now. This could have been predicted from studies way back in the 1960s and 70s which showed that polypropylene is inherently unstable.
"My opinion is it shouldn't be used in routine clinical practice until there are more clinical trials and more research into the stability of the mesh.
"The surgery does help some people although we do know they could be at risk of long-term complications because mesh erosion does sometimes happen after five, 10 or sometimes 20 years."
"Polypropylene is long-studied and well-supported as a material for use in mesh, which has been used in millions of patients and by surgeons worldwide.
"Our polypropylene mesh has been subjected to every test required or suggested by regulatory agencies to measure its performance and fitness for use in medical devices destined for human implant."
The Independent Medicines and Medical Devices Safety Review, which is also investigating the cases of Primodos and Sodium Valproate, is expected to report back by the end of the year.