(August 9, 2018) Women’s pelvic mesh use was suspended in England last month pending government review. English regulators suspended the surgical use of transvaginal mesh after listening to mesh-related horror stories from several women. The politicians listened as dozens of women detailed stories of how the mesh has caused them excruciating misery and endless pain.
Related: Transvaginal Mesh Lawsuit
The suspension means surgical mesh meant to treat stress urinary incontinence is not to be used again in England until the mesh meets five strict conditions which thousands of mesh-injured women campaigned to demand. Many of the women belong to a group of 6,100 people called ‘Sling the Mesh.’ Members have called attention to problems with both women’s pelvic mesh, hernia mesh, as well as rectopexy mesh, used to treat rectal prolapse.
Sling the Mesh
“This is incredible news,” said ‘Sling the Mesh’ founder Kath Sansom. “It is a testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result, and I am delighted.”
The government review of mesh is scheduled to conclude in March 2019. It will determine if the suspension of the plastic mesh used in people will become permanent.
Ms. Sansom brought the anti-mesh campaigners to Parliament, which led to an internal investigation by the National Health Services, as well as debates in the House of Commons. That action led to more public awareness of the severe complications surgical mesh can cause. In the U.S., widespread use of transvaginal mesh has led to a virtual catastrophe, with more than 100,000 women filing lawsuits at one time over plastic mesh complications.
In February 2018, the government announced a review of surgical mesh. Regulators planned to meet face-to-face with citizens around the UK. Health and Social Care Secretary Jeremy Hunt said the government’s final recommendation should be publicized next March.
Baroness Julia Cumberlege led the mesh review. Medical Mesh News Desk reported that she was so moved by the stories she heard that she suggested an immediate suspension in the use of surgical mesh for stress urinary incontinence (SUI). Ms. Cumberlege believes rectopexy mesh for rectal prolapse should also be suspended.
Human Suffering outweighs Benefits of Mesh
“We strongly believe mesh must not be used to treat women with SUI until we can manage the risk of complications much more effectively,” Ms. Cumberlege told the Daily Mail. “ We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications. I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.”
Baroness Julia Cumberlege“We had to act now,” said Ms. Cumberlege. “My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries.”
Five Conditions Must Be Met
There’s no ban for now, but a “halt” to procedures pending five conditions:
- Surgeons may perform an SUI operation only if they receive proper training and regularly perform surgeries.
- Surgeons must report every procedure to a national database.
- A surgeries registry will be maintained to note the type of procedure and the woman involved.
- Complication reports to the MRHA must be linked to the register.
- Specialized centers must be identified and accredited to deal with complications and removals.
As in the U.S., mesh proponents claimed that only prolapse surgeries should be banned. Health regulators, however, acknowledge that three-quarters of pelvic mesh surgeries are done to treat SUI, and they account for most of the horror stories.
An estimated 130,000 UK patients have had an SUI or POP procedure in the past decade. Complication rates have been found up to 42%, with 30% reporting a lost or reduced sex life, and urinary infections reported at 22%, with bladder perforation in 31 percent of cases.
Women across the globe have complained of pelvic mesh complications. Mesh-injured women in Scotland have also addressed their government directly and achieved a suspension on the mesh used for SUI. That suspension came in 2014 after a consistent talking campaign as well as extensive media coverage from an enterprising reporter, Marion Scott.
New Zealand also suspended mesh use for pelvic organ prolapse (POP) as well as incontinence, while Australia suspended mesh use for POP. Hundreds of Australian women have filed lawsuits against Ethicon over its mesh implants.
Sling the Mesh Reaction
Ms. Sansom, who is also a CambsTimes reporter, said, “I think the really positive thing about the suspension is the government is finally listening to us and realizing just how awful it is when these mesh implants go wrong.”
She noted the government is not suspending the use of mesh for rectal prolapse, which Ms. Cumberlege also called for. Ms. Sansom also noted the same plastic is used for hernia repairs and they are starting to get the same complications, pain loss of sex life, autoimmune conditions.
British Urogynaecology (BSUG) Disagrees with Mesh Suspension
The British Society of Urogynaecology (BSUG) strongly disagrees with the decision to suspend the use of surgical mesh for stress urinary incontinence recommended by the All Party Parliamentary Group (APPG).
The government’s decision is not based on any scientific logic or thinking, claim BSUG members. The statement is signed by Professor Jonathan Duckett chairman of the BSUG.
Kath Sansom: BSUG Deluded
Kath Sansom tells MND that the BSUG group is “Absolutely deluded, defensive, sounds very angry, totally not supportive to women and peddling the tired old myth that this is the most trialed procedure out there. These are the aggressive urogyn surgeons. It is very clear they have put a lot of pressure on Govt following Baroness C’s call to “pause.”
Government Trials Flawed
Ms. Sansom believes the government trials that are underway are flawed for several reasons:
- Most trials are not randomized, but simply mesh vs. mesh; there’s no control group.
- Most trials are short term, roughly two years, shy of when most problems start.
- Tiny cohorts: One study of 90 women drops to 58 after 17 yrs., a drop of 22%. Even a 5% drop adds significant bias to a study.
- Poor quality of life (QoL) studies fail to look at new onset of chronic pain, nerve damage, urinary infections, loss sex life, etc.
- Most QoL questions are based on the SUI pad test. Ludicrous!
- Many trials authors have conflicts of interest. In the Pt. 3 trial above, two authors were paid by Ethicon, which makes the mesh slings being “tested.”
- Many trials come up with damning statistics and then ignore them. One by Brubaker et al shows a 42% risk, but the abstract/conclusion claims it is only short term and says mesh is an effective treatment option. (Ludicrous!) Busy doctors don’t take the time to read through every report so they believe the hype.
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by Matthews & Associates