Vaginal Mesh Implants: Experimental! NICE

Vaginal mesh operations should be banned, says NICE

By Anna Collinson

Reporter, Victoria Derbyshire programme

• 27 November 2017  FiDA highlight
  

Draft guidelines from NICE say the implants should only be used for research - and not routine operations.

Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.

One expert said it is highly likely the NHS will take up the recommendation.

However, the organisation is not compelled to act on findings it receives from NICE.

Both NHS England and NICE declined to comment.

'Life-changing consequences'

In the documents - to be published after consultation in December - NICE said there were "serious but well-recognised safety concerns" and that "evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity".

It added that "when complications occur, these can be serious and have life-changing consequences", but said "most commentaries received from patients reported satisfaction with the procedure".

One woman, Margie Maguire, 41 - told the Victoria Derbyshire programme she cannot have any more children or walk unaided because of the damage caused by the mesh.

"I have chronic pelvic pain on a daily basis and I'm on nine different medications when I have a pain attack.

"These can last from two to six hours at a time and is like having a heart attack," she said.

Kate Langley told the programme in April she had been admitted to hospital 53 times to try to end the pain, but - like many women - the mesh was so near the nerve it could not be fully removed.

She has been left with nerve damage and in permanent pain by the implants, giving up her business as a childminder because the pain was so intense.

The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina - protruding through"

The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.

They are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.

The University of Oxford's Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had "got this wrong" - calling the use of mesh a "catastrophe".

He described the draft guidelines as a "backdoor ban" on implants that would effectively end their use.

But he said it had come too late.

"Seven years I have been watching this emerge - it is absolutely farcical how bad it is. Either they're burying their heads in the sand or they don't know what they're doing."

He called for a registry to be created for everyone who had been treated with the implants so that their effects could be fully understood.

In April, the BBC learned more than 800 UK women are taking legal action against the NHS and the makers of vaginal mesh implants.

The NICE documents suggest "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".

Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics.

About one in 11 women has experienced problems, the data suggests.

The use of vaginal mesh to treat urinary incontinence is not mentioned in the draft NICE guidelines.

In Scotland, former Scottish Health Secretary Alex Neil requested a suspension of mesh implants by the NHS in 2014, but figures obtained by the BBC in December 2016 showed hundreds of operations have been performed since.

A number of Scottish health boards have stopped using mesh implants altogether.

The mesh is also used routinely in hernia repair despite concerns it is leaving many patients in chronic pain.

The Department of Health declined to comment.

Watch the Victoria Derbyshire programme on weekdays between 09:00 and 11:00 on BBC Two and the BBC News Channel.

http://www.bbc.com/news/health-42110076

All meshed up in Iowa. Stabbed a thousand times a day.

Surgical mesh causes pain, complications in somepatients

February 17, 2014 FiDA highlight added  The Gazette

A 2005 surgery meant to correct Frances Schulte’s (from Coralville, Iowa) urinary incontinence brought her pain and further embarrassment rather than relief.

Doctors implanted a medical device known as surgical mesh, which has since eroded — which means her mesh sling is poking and irritating nearby organs.

“I get stabbed thousands of times a day,” Schulte said. “People don’t understand that I’m in pain every day.”

Schulte, whose surgery was done in Illinois, said that the pain prevents her from comfortably moving around and going to the bathroom.

Surgical mesh, which is generally used to repair weakened or damaged tissue, is made from synthetic material. It is permanently implanted to reinforce a weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence, which can commonly occur in older women, women who have had children and women who are obese.

However, more than 1,000 adverse events were reported to the U.S. Federal Drug Administration between 2005 and 2007, which caused the agency to issue a Public Health Notification in 2008. Since then, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse.

The most common complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, organ perforation and urinary problems.

“Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” the FDA states on its website.

The FDA has stated that complications associated with the use of surgical mesh have not been linked to a single brand. But Schulte, along with thousands of other women nationwide, opted to seek legal action.

Multiple class-action lawsuits have been filed against various makers of the mesh. Cases against Johnson & Johnson, C.R. Bard, Endo Health Solutions Inc. and Boston Scientific Corp. are all winding their way through federal court in the Southern District of West Virginia.

“I don’t like that they’re still putting it (the mesh) into people,” Schulte said.

Less risky alternatives 

Dr. Catherine Bradley, an OB/GYN and division director of urogynecology and reconstructive pelvic surgery at the University of Iowa Hospitals and Clinics, said that a polypropylene mesh sling was first introduced to the United States in 1998. It was developed by Scandinavian researchers and was tested with promising results.

As the medical device became more popular, other companies began developing similar products, Bradley said.

“I don’t think these were tested as much as they should have been, and the FDA approval was probably inadequate,” she said.

She added that she never used transvaginal mesh for her patients because she was uncomfortable with the studies that had been completed.

Bradley noted that the FDA since has required companies making these products to do more rigorous testing, which can be expensive — this, combined with the class-action lawsuits, has led to some companies to no longer sell the product.

Instead, she opts to treat women suffering from pelvic organ prolapse through surgery without mesh in less severe cases and, when necessary by sacral colpopexy, a less-invasive surgery in which mesh is added through an incision made in the abdomen.

Bradley said there is only about a 5 percent risk of erosion when mesh is implanted this way, compared with a 10 percent and sometimes higher risk of erosion when mesh is applied transvaginally. Removing eroded mesh is difficult, but the removal can help with the pain.

“With abdominal surgery, you are also less likely to have pain than a transvaginal surgery, even one without mesh,” she said.

“As a surgeon who treats women and uses mesh, we complain about how much time we spend talking about it,” she said. “But it’s better that we’re spending more time talking with patients and counseling patients that we can’t always cure (their problems) without complications arising.”