Patients deserve better than this. Surgeon speaks of the ‘Absolute disaster’ of global approval systems for women’s pelvic mesh kits

Surgeon Lewis Wall first spoke of his concerns over the use of mesh kits in 2009 when he wrote the a

Surgeon Lewis Wall first spoke of his concerns over the use of mesh kits in 2009 when he wrote the article Commercial Pressure and Professional Ethics with Douglas Brown. - Credit: James Byard/WUSTL Photos

Warnings were given as long ago as 2009 about the dangers of surgical mesh and its implanting hooks by a respected surgeon who said the kits had everything to fix women’s pelvic health problems - except ethics and sound judgement.

Professor Lewis Wall said his father was a gynaecologist before him and would be horrified at what has happened to his profession.

“Before the advent of mesh kits, there was little commercial interest in gynaecologic surgery aside from the sale of sutures or catheters, but now there are operation-specific kits, huge profits are on the table,” he said.

“Almost everything you need to operate - except good clinical judgment and technical skill - is right there, fresh out of the box.

“Patients deserve better than this.

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“Surgeons wanted to fix all these problems with prolapse without having to train up for the more complex native tissue repairs that took years of experience and skill.

“Mesh kits involve inserting a synthetic mesh tape into a contaminated surgical field using trocars, done blind – it is asking for trouble.”

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He continued: “It is not good enough to say that abdominal mesh has been proven safe for hernia repairs so it is OK to use it in the vagina; the vagina isn’t the same thing as the belly wall.

“Add in the absolute disaster of our approval system for surgical devices that only works to the advantage of shareholders.

“Mesh kits may make intellectual sense but is not the same as ethical sense.

“My father was a gynaecologist and would be horrified at what has happened to his profession.”

Approval systems around the world are flawed which means mesh being implanted into women without strong clinical trials to prove it is safe and effective, he added.

In 2009 Mr Wall and Douglas Brown wrote a report warning that commercial interests were reshaping gynaecology and the dangers of allowing industry to have too heavy a hand in medicine.

Unlike drugs, which must be shown by clinical trials to be both safe and effective prior to launch, if a device is “equivalent” to something that is already being implanted into patients, it is allowed to enter the market.

Independent trials are not needed.

It is how the PIP breast implant scandal – using mattress grade silicone instead of human grade – managed to happen.

Mr Wall said of mesh kits: “The procedures should be considered experimental and patients should consent to surgery with that understanding.

“Certainly in the early days of mesh kits I believe surgeons weren’t deliberately injuring women, but there were a lot of aggressive salesmen and a lot of naive doctors who believed the glossy marketing brochures and didn’t want to fall behind on surgical practice, so they jumped on the bandwagon before the evidence was in.

“There’s so much money and profits at stake its mind boggling,” he saied.

However, there’s a fundamental opposition between medicine and business - in business profitability comes first.

“In business you look at costs – if profits are $200b and you have to set aside $60b for compensation then it is $140b profit. So the product is a goer.

“In medicine the first priority must always be the best interests of the patients. Often there is a clash.”

“Mesh is less aggressively marketed now than it was but the real problem came in the first few years – once it was in the public arena it went crazy.”

• Read the report Commercial Pressures and Professional Ethics and a thread of discussion that followed in this link here.

• Lewis Wall is a professor of obstetrics and gynaecology at Washington University in St Louis, Missouri. Read his biography here.

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