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Vaginal mesh study reveals how lax medical regulation puts women at risk



Failures in the regulation of vaginal mesh implants put women at risk of severe infection and chronic pain, experts say.

Researchers found lax rules about medical devices, which allow products to be approved in an "equivalence" if they are similar to an already approved device, 61 mesh implants can be commercialized based on the evidence of two more products old

Although regulators have plans to strengthen supervision, which includes requiring clinical trials for each medical device in line with drug approval, these will not be fully effective until 2020.

Oxford University scholars argue that a public record of all invasive medical devices must be established to allow long-term follow-up with patients to ensure the safety of the device. 1

9659002] The scandal that develops around transvaginal mesh implants (TVM) has been listed as the most serious failure of women's health since thalidomide.

Vaginal mesh implants are administered through arou and 15,000 women each year to address postpartum complications such as urinary incontinence and prolapse, where weakened pelvic muscles mean that organs can bulge into the vagina.

More than 100,000 women in the US UU They are involved in a class action lawsuit with manufacturers after complications are relatively rare, but independent academics say they are more common with mesh implants to treat prolapse and surgical repair is likely to be performed. more effective.

Of the 110 formally related and related adverse incidents reported by the medical device control agency of the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA), since 2005, 65 were for the device to break in vagina, 21 related to infections, 39 related to pain and 16 related to organ perforation.

The Independent has followed t Growing public outcry about mesh implants as a result of the government's refusal to ban devices or initiate a public inquiry into their use after a national report on the subject .

This week has also seen the first death reported as a result of a TVM device.

The procedure of cross-call to the final mesh ends in disappointment

The Canadian defender of the mesh and mother Chrissy Brajcic died after developing an infection resistant to the antibiotics of her implant.

The document, published in BMJ Open today, used data for devices approved by the US Food and Drug Administration. UU

In one analysis, the authors said: "We traced the marketing authorization for 61 mesh devices through a chain of equivalence statements, only two unique source devices approved in 1985 and 1996.

found evidence of no new clinical trial at the time of device approval for all these 61 devices, with empirical evidence of effectiveness of randomized trials emerged on average five years after approval. "

Warns that this" family tree "of equivalency approvals meant that devices with different designs were marketed without evidence of safety, and when changes should have alerted regulators that equivalence was not applicable.

The authors cautioned that in Europe devices can also be approved by equivalence, with the approval of centers across the European Union.

But, unlike US applications, EU approvals are not public, so " Impossible to examine. "

The lead author of the study said he hoped that after Brexit, the UK would adopt a more rigorous approach that would incentivize evidence-supported devices and prioritize" patient safety. "

Professor Carl Heneghan at the University of Oxford Center for Evidence Based Medicine said patients could wait longer for t and companies could "lose market share," but added: "We could, and should" however, lead the way by having regulatory systems that incentivize the production of high-quality evidence at the time of approval for implantable devices. , those that are considered the most risky.

"In particular, ensure that the devices that make the difference and are safe are available, and for those that are not safe, making sure they do not come on the market in the first place."

At the end of this month, the National Institute of Health and Care of Excellence (NICE) of England will publish the final guide on devices.

The watchdog could say that the devices are no longer recommended for use; that should only be used for research purposes; or should only be used when doctors have had certain conversations with potential patients about possible side effects or complications.

Debate between parties on the mesh procedure

independent academics endorsed the plan for an "adjustment" record and regulation, especially because the implanted devices usually last a lifetime.

Professor Cathryn Glazener, a retired professor emeritus of the Health Services Research Unit at the University of Aberdeen, did not contribute to the work and marked that account for safer and more effective mesh implants. for incontinence.

But he added: "I agree with the authors of the article, however, that the regulation of the use of new devices must be reinforced, in line with the much more rigorous scrutiny that already exists for new drugs." [19659002] The MHRA, which continues to recommend mesh devices, citing "insufficient evidence" of widespread complications for a ban, said it is looking for such a record and encouraged the woman to report any complications.

John Wilkinson, director of devices at MHRA, said: "Patient safety is our top priority and we recognize that some women develop serious complications that may be very important for affected women."

"We also know that many women they get benefits from these surgical procedures so they can be extremely debilitating conditions. "

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