BD has become the subject of a lawsuit from Tela Bio, with the rival maker of surgical mesh implants saying the major medtech wielded its sector dominance to push competing products out of the hernia repair market.
First reported by Reuters, Tela claimed in the lawsuit that BD pursued conditional pricing and multi-year bundling contracts through group purchasing organizations, integrated delivery networks and individual hospitals, all designed to block them from stocking Tela’s OviTex reinforced biologic mesh.
Cleared by the FDA in 2016, OviTex employs a sheep-derived extracellular matrix interwoven with synthetic fibers for added support. The company said the hybrid is designed to combine the benefits of synthetic and tissue-based materials and is compatible with open surgery, such as robotic and laparoscopic approaches.
BD’s mesh catalog, including its top-selling Phasix line, currently takes about 65% of the money spent on permanent hernia meshes and 77% of the market for resorbable implants, according to Tela’s lawsuit filed last week in the federal district court in Philadelphia.
The company alleged that BD’s commercial arrangements have substantially injured its OviTex business and driven higher prices for providers and patients—with Phasix meshes costing about $4,500 per unit on average, compared with OviTex’s approximate $3,000 price, according to the suit.
“BD operates fairly in a complex, highly competitive industry, complying with all laws and regulations governing our commercial activities,” BD said in a statement to Fierce Medtech through a company spokesperson. “The allegations in this matter are without merit and BD will vigorously defend against these claims.”
Tela estimates that hernia repairs represent one of the most common surgeries in the U.S., with about 1.5 million procedures costing $12 billion annually. The company said meshes are used in about 80% of cases to help reduce the risk that a hernia will recur.
It said in the filing that despite OviTex’s competitive pricing, the mesh was unable to break an 8% dollar share of the U.S. resorbable market in 2024—but Tela claimed its products have performed better in the U.K., where BD does not have the same contracts in place. Tela reported $69.3 million in total revenue for that year, up 19%, alongside a net loss of $37.8 million.
Last year saw BD settle about 38,000 hernia mesh injury lawsuits, with some cases going back years. The terms of the settlement were not disclosed, though Reuters reported at the time that it amounted to a “large majority” of the $1.7 billion BD had previously set aside for liability claims.
Editor's note: This story has been updated with a statement from BD.