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Harm Caused by Vaginal Mesh Traced to Regulatory Loophole

The flawed approval system for medical devices is to blame for the harm caused by vaginal mesh implants, according to a new study. It maintains that if clinical trials had been conducted prior to the marketing of such devices, the serious risks would have been discovered and disclosed much more quickly. The publication of the study comes on the heels of a recent Guardian report that a vaginal mesh implant made by Johnson & Johnson was launched without a clinical trial. It was then marketed for five years after the company had learned that it had a higher failure rate than its two earlier devices.

Vaginal Mesh Risks

Vaginal mesh devices were cleared for use in treating incontinence in 1996 and for pelvic organ prolapse in 2002. Since then, the U.S. Food and Drug Administration (FDA) has concluded that vaginal mesh implants do little to improve pelvic organ prolapse (POP), a condition where a woman’s uterus, bladder, or rectum can slip out of place. In many cases, the medical device exposes patients to a number of serious risks, including erosion of mesh through the vagina. The complication can require multiple surgeries to repair and can be debilitating for some women.

In 2016, the FDA reclassified vaginal mesh devices as class III, which generally includes high-risk devices. It also now requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

Manufacturers of vaginal mesh implants are also facing thousands of lawsuits across the country. Last year, the State of California filed a consumer fraud lawsuit alleging that Johnson & Johnson failed to warn doctors and patients about serious complications associated with its pelvic mesh devices. The suit further contends that J&J violated the state’s consumer protection laws by using deceptive advertising to market the vaginal mesh products.

FDA Approval of Vaginal Mesh Implants

As we have previously discussed on this blog, medical devices are often approved by the FDA without clinical trial data requirements. Transvaginal mesh devices are approved by the FDA through the 510(k) system. It allows manufacturers who demonstrate their products are “substantially similar” to other products on the market to obtain clearance to sell the device without undergoing a stringent review process.

The latest study on vaginal mesh examined how these devices ended up on the market. It revealed that the marketing clearance for 61 mesh devices can be traced back to just two original devices approved in 1985 and 1996. The researchers further found that clinical trial evidence did not form part of the approval process, and when trials were conducted, they occurred a considerable time later. “We found no evidence of any new clinical trial data at the time of device approval for all of these 61 devices, with empirical evidence of effectiveness from randomised trials emerging on average five years after approval,” the authors wrote.

Because manufacturers were able to rely on the 510(k) process, numerous vaginal mesh products with different designs entered the market without sufficient safety evidence. “Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years,” the authors said. “When evidence has been forthcoming, it has often emerged too late to inform clinical practice,” they added. “The current systems for ensuring patient safety are inadequate for medical devices.”

Prof. Carl Heneghan at Oxford’s Centre for Evidence-Based Medicine, who led the work, was more blunt, stating: “Many women have been subjected to great harm because regulatory loopholes allowed mesh devices to be made available in large numbers with no evidence in humans. It is now clear that regulation is not fit for purpose for the riskiest of devices, those that are implanted in the body.” He added: “We now know that women who received mesh implants have been part of a global experiment that in many cases has gone badly wrong.”

In light of their findings, the researchers argue that that clinical trials evidence should be mandatory for marketing authorization of all implantable devices and that there should be incentives for the development of high-quality evidence-based devices. They further maintain that a publicly accessible registry of licensed invasive devices with details of marketing status and linked evidence should be created.

Contact Us

If you or someone you care about has suffered serious harm due to a vaginal mesh or another dangerous medical device, don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation. Our legal team has successfully represented clients against manufacturers and distributors of medical devices for more than 30 years.