BD (Becton, Dickinson and Company) announced the FDA 510(k) clearance and commercial launch of its Phasix ST Umbilical Hernia Patch this week.
BD says the device is the first fully bioabsorbable hernia mesh specifically designed for umbilical hernia repair.
The Phasix ST Umbilical Hernia Patch offers a unique absorbable solution for umbilical hernia repair, the company said.
It is constructed from poly-4-hydroxybutyrate (P4HB), a biologically derived material, and features a hydrogel barrier based on BD’s Sepra Technology. Sepra was developed by Genzyme, which then partnered with C.R. Bard (now part of BD) for its manufacturing and marketing.
BD says Phasix’s design allows for deployment using the same surgical techniques as traditional permanent mesh patches, facilitating ease of adoption for surgeons.
The patch is the latest addition to BD’s Phasix Mesh portfolio.
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The patch incorporates a pocket and strap configuration to aid in placement, positioning and lateral fixation. This mirrors the form and function of BD’s Ventralex ST Hernia Patch — a product with over 2 million global implants, according to BD.
Available in three sizes, it accommodates a broad spectrum of umbilical soft tissue defects.
It allows for sufficient mesh overlap, helping to meet surgeon preferences.
According to BD, survey data indicate that 60% of patients prefer a non-permanent mesh option for hernia repair.
And more than 70% of surgeons are willing to accommodate patient mesh preferences.
BD’s Strategic Focus on Bioabsorbable Mesh Amid Legal Challenges
The Phasix ST Umbilical Hernia Patch is the latest addition to BD’s Phasix Mesh portfolio. The portfolio includes over 385,000 implants globally. It is supported by more than 85 clinical publications involving over 4,000 patients.
“BD is redefining tissue repair through advanced biomaterials and expanding treatment options to meet individual patient needs through proven, reliable alternatives to permanent mesh,” said Ron Silverman, chief medical officer for BD.
“This marks another milestone in hernia repair innovation and further positions BD as a leader in advanced biomaterial science — driving transformative change in tissue reconstruction.”
BD’s launch of the first fully bioabsorbable mesh for umbilical hernia repair marks a significant innovation in a space where the company has faced notable challenges.
Over the years, BD has faced extensive litigation related to its legacy hernia mesh products. This culminated in a major settlement agreement to resolve approximately 38,000 lawsuits alleging product-related injuries.
BD reached the settlement in October last year. Some of the lawsuits go back nearly two decades.
While specific terms of the agreement remain undisclosed, BD indicated that it involves a substantial portion of the $1.7 billion it had previously reserved for product liability cases. The first payments were expected to be made at the end of 2024. Further payments will be distributed over several years, according to BD.
Despite the settlement, BD has not admitted liability and plans to defend against any remaining individual cases.
The development comes on the heels of the company’s launch of the HemoSphere Alta platform also this week. The platform is a hemodynamic monitoring system that uses AI-powered predictive algorithms. It stabilizes blood pressure and optimizes blood flow during medical procedures.
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