Plaintiffs wonder if the product would have been approved had it been subjected to the normal, lengthy clinical trial process that Ethicon, a unit of pharmaceutical giant Johnson & Johnson (J&J), was spared through the approval of a 510(k) Clearance.
Plaintiff Sarah Gilman filed a surgical mesh lawsuit against J&J after receiving the allegedly defective Physiomesh Composite mesh last year for the repair of a ventral abdominal hernia (Gilman v. Johnson & Johnson et al., Case No. 8:16-cv-03502, filed December 27, 2016). It wasn’t long before Gilman began experiencing health complications that included, but not limited to the adhesion of the mesh to vital organs.
Gilman had to undergo a second procedure to have the problematic mesh removed. Gilman filed her hernia mesh lawsuit in US District Court for the Middle District of Florida.
A similar story involves plaintiff Connie Franklin, a resident of Georgia who received the Ethicon Physio abdominal mesh for a hernia repair (Franklin et al v. Johnson & Johnson et al., Case No. 4:2017-cv-00031, filed February 2, 2017). After experiencing health complications that included nausea and severe pain, Franklin went under the knife a second time in 2016 to have the Physiomesh removed. During the procedure, surgeons discovered a tear in the Physiomesh product, through which Franklin’s intestines had protruded.
The failure was characterized as catastrophic. Franklin filed her surgical mesh complications lawsuit in US District Court for the Middle District of Georgia.
Ethicon Physiomesh is designed for the repair of hernia. It is normally inserted laparoscopically through a small incision and deployed at the intended site. Laparoscopic surgery is becoming a new standard for certain procedures as it minimizes blood loss, and the smaller incision speeds healing while reducing strain on hospitals and frees up beds more quickly. Surgeons perform the procedure aided by a camera.
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A rate of complications deemed higher than expected coincided with a large study that suggested possible safety risks for patients. Upon analyzing unpublished data from two, sizable independent hernia registries located in Denmark and Germany, Ethicon made the decision to voluntarily recall the product in several countries, including Australia and Europe as well as the US.
An Urgent Field Safety Notice was issued by the manufacturer last May.
The approval of Ethicon Physiomesh through an FDA 501(k) clearance provides additional fodder for plaintiffs bringing a hernia patch lawsuit.