A new biomaterial testing method developed by scientists at the University of Sheffield can help identify those biomaterials that are not suitable for clinical use, thereby helping to avoid the recurrence of the vaginal net scandal.

Polypropylene surgical mesh, also known as PP mesh, when used for pelvic floor repair for stress urinary incontinence or support for pelvic organ prolapse, can cause serious clinical complications in some women.

The use of biomaterials in medical practice has increased significantly, including contact lenses, pacemakers, heart valves and orthopedic devices. This new test method can form the basis of an early warning system to mark conditions that may suffer fiber breakage and oxidative damage during implantation.

Dr. Nicholas Farr and colleagues from the Department of Materials Science and Engineering at the University of Sheffield have created a simple new in vitro test method that has the potential to evaluate the clinical applicability of biomaterials without the need for initial in vivo studies.

"New biomaterials are being widely developed, and before making critical deployment decisions, researchers must choose the most appropriate method to analyze these future implants," Dr. Farr told Medscape UK.

"In the past few years, I have studied many different forms of biomaterials, from bone tissue substitutes to potential nerve guide catheters. The purpose of this process is to confirm with high confidence that biomaterials are safe for clinical use."

He explained that the new test method can better simulate the deployment environment—such as the environment inside the body—and better identify cracks and surface degradation in biological materials than currently used methods.

The oxidative stress test subjects biological materials to oxidative pressure and mechanical pressure to simulate the conditions in the patient's body. This allows manufacturers to better understand how their biomaterials may behave in clinical use over time, and to flag any problems that may occur when using them for medical purposes.

A study published by Dr. Farr and his colleagues in the latest issue of RSC Advances outlines how they developed a new test method and reveals new insights into why polypropylene mesh is not suitable for clinical use in the pelvic floor.

Polypropylene mesh surgery has brought life-changing complications to thousands of women, leading to restrictions on its use and medical negligence lawsuits, and NHS Scotland launched a complex pelvic mesh removal service in the summer.

"The polypropylene material used to provide support for the pelvic floor is very strong, but it has caused serious complications for many women. In this study, we observed how this material behaves under simulated pressure conditions," co-author reputation Professor Sheila McNeill said that, also from the University of Sheffield, he worked with Professor Chris Chapel, a consultant urology department at Sheffield Teaching Hospital, to develop alternative and safer materials for the pelvic floor.

“We stretch the material repeatedly for 3 days to subject it to mild oxidative stress, and then we use very sensitive tests to reveal tiny cracks and cracks on the surface of the material,” she said. "Our extensive research shows that this material does not respond well under pressure."

The researchers concluded that the stress applied to the polypropylene mesh in the body may cause the polymer to oxidize and change the molecular structure of the material, causing it to rupture and release etched oxidized insoluble particles, leading to an inflammatory response.

"With regard to the implantation of polypropylene mesh in the pelvic floor, it was later found that the consequences of deploying materials were inappropriate in some cases, which seriously affected the trust of the public. It is recommended that through the implementation of our method, we can bring together stakeholders, including Biomaterials researchers and manufacturers, clinicians and practitioners to improve the choice of biomaterials to help provide safe and purpose-fitting life-changing therapies," Dr. Farr told Medscape UK.

The independent review of three controversial medical interventions, including pelvic mesh implants, criticized the failure of medical supervision and the slowness in taking action on women’s reports of complications from vaginal mesh surgery.

The July 2020 report of the Independent Drug and Medical Device Safety Review hosted by Baroness Julia Cumberlege found that the healthcare system including NHS, private suppliers, regulatory agencies, professional institutions, pharmaceutical and device manufacturers, and policy makers" Disjointed, isolated, unresponsive and defensive".

"It does not fully recognize that the patient is the reason for its existence. It does not listen to their worries. When it has not decided to take action, it is often slow to act."

The review made many recommendations, including calls for a comprehensive reform of the Medicines and Healthcare Products Regulatory Agency (MHRA), independent patient safety specialists, and the central database of all implanted devices to strengthen post-market surveillance. The Baroness Cumberleg said that most of the pain suffered by women is "completely avoidable, but caused and exacerbated by defects in the health system itself."

Send comments and news alerts to uknewsdesk@medscape.net.

To quote this: Priscilla Lynch. British scientists have developed a new biomaterial testing method-Medscape-December 10, 2021.

Priscilla Lynch is a freelance writer for Univadis from Medscape.

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