A team of medical experts from the University of Oxford are warning women about the dangers of improperly-designed mesh products, such as vaginal mesh implants, which are for women who have experienced incontinence or organ prolapse. However, it has been discovered that mesh products were approved on weak evidence and are now doing more harm than good.
“Many women have been subjected to great harm because regulatory loopholes have allowed mesh devices to be made available in large numbers with no evidence in humans,” Heneghan said. “It is now clear that regulation is not fit for purpose for the riskiest of devices, those that are implanted in the body.”
It isn’t difficult to see the complications Heneghan is talking about, considering that vaginal mesh lawsuits have been plentiful since the first case went to trial in 2012 and 2013. Now, almost every company that has been a part of multidistrict litigation has agreed to settle the thousands of claims made against them. For some companies, like American Medical Systems, the settlements cost upwards of $800m, although even $800m can be considered cheap when it’s settling thousands of cases.
Deborah Barba, who claimed Boston Scientific’s Pinnacle and Advantage Fit mesh implants were defectively designed, was awarded $100m by a Delaware jury after claiming to experience vaginal scarring and constant pain after the mesh eroded inside of her body.
It took a while, but Heneghan says that we’ve finally figured out that “women who have received mesh implants have been part of a global experiment that in many cases has gone badly wrong.”
“The current systems for ensuring patient safety,” which do not include mandatory clinical trials, “are inadequate for medical services,” says Heneghan.
The team found that 61 devices that were approved on equivalence claims (that they work similarly to products already in the market) had no clinical-trial evidence at the time of their approval. Instead, Heneghan and his team discovered that randomised clinical trials were found to be published an average of five years after device approval.
One similar instance happened under Johnson & Johnson in September. The company launched a vaginal mesh implant without a clinical trial, marketed the product for five years, and then found out the mesh had a higher failure rate than its two earlier devices.
The research team, led by Heneghan, is calling for clinical trials to be made mandatory if an implantable device is to be marketed. He also calls for a registry to be made so that those associated with a faulty product can be found and alerted.
Not all vaginal mesh users are at equal risk. Cathryn Glazener, an emeritus professor at the University of Aberdeen, said that while tighter regulation is needed, there also needs to be a distinction between the use of mesh to treat incontinence and the use of mesh to treat prolapse, which is more risky.
Later in December, England’s National Institute for Health and Care Excellence will release information that is expected to recommend that vaginal mesh not be used for prolapse, considering the risks.
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