Over the past few years, controversies surrounding the use of urogynecological mesh (transvaginal mesh), which is used in the treatment of urinary incontinence and pelvic organ prolapse, have drawn the attention of healthcare providers and organizations worldwide.
These issues began to come to light in 2008 when severe complications were reported in patients from multiple regions, including the US, due to the use of transvaginal mesh, leading physicians and consumer health groups to raise questions around the safety of these products.
However, in some regions such as Japan, practices such as informed patient consent and patient counselling prior to the use of meshes have led to these products being used safely, and physicians in those countries still prefer the use of mesh over other alternatives, such as obliterative surgery and native tissue repair.
In this piece, DRG Medtech analysts look into the current status of the global urogynecological mesh market and explore lessons learned from global markets.
Litigation and Negative Media Coverage Have Impacted the Urogynecological Mesh Market in the US, Europe, and Australia
As a result of complications suffered by urogynecological mesh patients, these products have received a great deal of negative media coverage. Because a large number of lawsuits against mesh manufacturers have been filed in the US and Australia, the influence of negative publicity and litigation has been strongest in those two countries, contributing to significant declines in the countries’ genitourinary mesh markets in recent years and spurring a number of competitors, such as Ethicon and C. R. Bard (prior to being acquired by BD), to exit this space.
Moreover, in April 2019, the FDA ordered urogynecological mesh manufacturers Boston Scientific and Coloplast—the only remaining mesh manufacturers on the market—to immediately halt the sales of their meshes in the US; the agency had determined that the two companies had not provided sufficient proof supporting the safety and effectiveness of their meshes after the products had been reclassified as Class III devices in 2016.
In addition to the impact this has on the US market, such regulatory action, which includes past FDA warnings as well, has also led to hesitance among European surgeons; however, product removals in Europe continue to be less frequent compared to the US, largely due to the smaller number of reported lawsuits in Europe.
In Other Countries, Safety Measures Have Been Implemented, Resulting in Continued Adoption of Urogynecological Meshes
In Latin America, Japan, and the Asia Pacific region (with the exception of Australia), urogynecological mesh products continue to be adopted by physicians due to their confidence in the effectiveness of these products compared to other alternatives.
According to interviewed physicians, in Japan, this confidence stems from guidelines and measures that have resulted in fewer mesh-related lawsuits in the country. These measures include informed patient consent and counselling prior to the use of these meshes, which represents an integral part of the procedure.
Additionally, health associations, such as the Japan Society of Obstetrics and Gynecology, are actively involved in the investigation of mesh-related complications, and surgeons have to undertake specialized courses provided by the Japanese Society of Female Pelvic Floor Medicine before performing procedures for Pelvic Organ Prolapse.
Health Care Authorities Across the Globe are Issuing Safety Orders and Reclassifying Risk Categorizations to Ensure More Cautious Usage of Urogynecological Meshes
In countries where mesh products have been heavily impacted by litigation and complications, such as the US and Australia, healthcare authorities and urogynecological associations are implementing strict measures to prevent future mesh-related complications; both the FDA and TGA reclassified urogynecological mesh as a Type III medical device, which means the device needs a PMA in US and is considered a high-risk device in Australia.
Furthermore, in February 2018, the American Urogynecologic Society released a statement that transvaginal mesh remains a viable surgical option but only for carefully selected patients. Similarly, in the UK, the government directives have led to a pause in the utilization of urogynecological mesh, and the NHS has notified all trustees and medical directors to restrict usage of these products until a set of conditions are met, including the publication of best practice guidelines, physician training, obtaining informed consent from the patient, maintaining a register for reporting of procedures and complications, and identifying specialist centers for patient surgery and post-surgical care.
With that said, urogynecological mesh manufacturers are facing increased scrutiny from regulatory authorities worldwide; for instance, the TGA has issued a warning to manufacturers to update the usage instructions for transvaginal mesh products in order to convey information on possible side effects following mesh insertion.
Given the heightened attention surrounding patient safety with urogynecological mesh products, all companies will benefit from providing and promoting clinical evidence to support the safety and efficacy of their urogynecological mesh products.
According to Industry Experts and Key Opinion Leaders, All Stakeholders Must be Involved in Recommending Next Steps on the Use of Urogynecological Mesh
The recovery of the urogynecological mesh market will be dependent on efforts from all stakeholders to ensure that patients are well informed about the risks associated with these products.
Although the fact that physicians are now spending additional time counselling patients on the use of mesh products is surely a positive development, going forward more emphasis should be laid on utilizing clinical data to determine safety and conducting risk-benefit assessments with patients prior to surgery.
For instance, as part of its Medical Device Safety Action Plan, the FDA has partnered with various urogynecological associations—including the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, the National Library of Medicine, and others—to form the Women’s Health Technologies Coordinated Registry Network (WHT-CRN). Through the WHT-CRN, the FDA aims to increasingly rely on real world data to determine the safety and effectiveness of women’s health technologies, including urogynecological mesh.
Such initiatives must be encouraged to ensure that the safety and effectiveness of women’s health products are supported by sufficient clinical evidence; going forward, the development of best practices and guidelines—both pre- and post-commercialization—will be critical in improving patient outcomes and providing patients with access to safe and efficacious devices.
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