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Backlash against Mesh Implant

Aug 3

Written by:
03/08/2018 09:19  RssIcon

Johnson & Johnson face class actions from hundreds of woman who have experienced chronic pain from the implant 

 

In 2006, Johnson & Johnson launched a mesh used to treat incontinence onto the medical market. The implant was approved in the US and EU without a clinical trial, and was used for the next six years in operations on thousands of women – even after the company discovered in 2007 that it had a higher failure rate than two earlier devices.

 

Image: Johnson and Johnson

 

Since then, hundreds of women have reported debilitating pain and the company is now facing class actions in Australia, the UK and the USA. 

In 2017, the first patient was awarded $57 million, after evidence emerged that the company ignored warnings from doctors – both those working for the company and conducting independent trials.

 

No clinical trial

Ethicon, a subsidiary of Johnson & Johnson, began producing the implant known as TVT Secur in 2006. The company had produced two earlier mesh implants, which meant that the new device could be approved for use in the EU and the USA without full clinical testing. 

The company began to market the implant after tests on sheep and five weeks’ monitoring in 31 women.

Although this process was legal, Carl Heneghan says that the approval has “led to direct patient harms”. But Ethicon saw its advantage as “priceless” in bringing the product to market ahead of competitors, according to company documents that emerged during a recent lawsuit against it.

Heneghan, who is professor of evidence-based medicine at the University of Oxford, says this behaviour was “unacceptable”. "It just blatantly says we don't care about patients. We don't care about safety, we just want to get out and start making money”.

Around 10,000 women receive transvaginal mesh implants each year in the UK as treatment for prolapse or urinary inconsonance, often following childbirth. For most, there are no serious complications. But since 2006 – when Johnson & Johnson launched the new mesh – the number experiencing chronic pain has significantly grown. 

 

Ignoring evidence

Ahead of the device’s original launch, Prof Bernard Jacquetin a French gynaecologist was invited to give advice on the implant. But on arrival he was presented with a finished product, boxed-up and ready for launch, he stated during the trial.

When Jacquetin and colleagues later carried out a study of 40 patients, they found that the new device had success rates of just 77% two months after surgery, far lower than the 85-90% success rates reported for Ethicon’s earlier devices. When Ethicon’s marketing manager, Fabrice Degeneve learned of the figures, he responded: “How should we handle this without compromising the use of this new technique?” emails from the recent lawsuit show.

Director of sales, Xavier Buchon, replied suggesting that the company withhold the results while reviewing the patients included in the analysis.

Emails from other Johnson & Johnson staff said that there was a dangerous blurring of the “lines between commercial and research” divisions and that colleagues were “constantly spinning data”.

 

Insufficient warnings

Since 2008, Ethicon’s own doctors also began expressing concern. The company’s associate medical director wrote to managers pointing out that the information Ethicon provided to surgeons was from 2005. In particular, she expressed concern that the “potential adverse reactions” had not been changed in the light of “post-market knowledge”. 

In 2009, she again wrote to managers, stating that several of the complications listed should no longer be referred to as “transitory”. "From what I see each day, these patient experiences are not 'transitory' at all.” However, Ethicon admits that it did not update the advice at the time.

Side-affects of the device can include vaginal scarring, painful sex, and pain in pelvic back and legs. A small minority of patients experience these side-effects. But for some they have been severe enough to leave the patient wheel-chair bound.

Ethicon last updated the advice in 2015 to state that some of these affects could be permanent. But even then the company is accused of using incomplete and insufficient risk assessment data to do so. 

Over 100,000 women are now suing manufacturers of the mesh in the US alone. Johnson & Johnson faces the greatest number of cases.

 

And what about the NHS? 

The NHS is also facing lawsuits from 800 women in the UK.

One in fifteen women have to had the device fully or partially removed, according to NHS data and the use of mesh has been suspended altogether as of July 2018 until it will be fully reviewed next year.

The incident has lead many to question the system for approving treatments before NHS use. Carl Heneghan stated that the decision to allow the treatment without clinical trial “made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients.”

 

Sling the Mesh

The Sling the Mesh campaign states that the use of vaginal mesh is the ‘Bigger disaster since thalidomide.” They have been campaigning to raise awareness of the issue and for the mesh’s use to be suspending pending review. 

 


 

 

 

 


 

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