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Surgeons increasingly rely on meshes, which are medical devices that are surgically implanted into a patient. A mesh is made from one or more sterile non-absorbent plastic materials. It serves as a prosthesis to support failing tissue, acting as a matrix or platform where normal tissue can grow. These medical devices require approval by the Food and Drug Administration (FDA) to assure they are safe and effective. If the device is substantially equivalent to one already approved, then it can gain FDA approval through its fast-track 510(k) program, which allows manufacturers to forgo clinical trials.
In 2002, the FDA gave a fast-track approval to Ventralex ST mesh, manufactured by Bard, to treat hernias. The approval was granted based on prior approval of mesh product, the Bard Kugel. Afterwards, the Bard Kugel was recalled because it was known to break, giving rise to bowel perforations and other complications. However, the Ventralex product was not recalled at that time.
Since being approved, several studies found problems with the Ventralex mesh. In one study, a comparison with Cousin Biotech’s Cabs’Air Composite mesh was made among 83 patients who had a hernia repair using one of the two products. The study revealed that placement of the Cabs’Air was easier. After three months, patients with Cabs’Air had less pain and higher satisfaction than those implanted with the Ventralex mesh. Long term follow-up revealed striking differences in outcomes. Complications including hernia recurrences, a mesh infection, small bowel obstruction, and severe pain from shrinkage were shown only in Ventralex patients.
A patient that was implanted with a Bard Ventralex ST Hernia Patch in 2013, recently filed a claim against Bard. The device was implanted to repair a hernia, but failed, and she had to undergo revision surgery the following year. Her doctor found significant adhesion formation. As a result, she is expected to require additional surgeries to correct the problem. A similar case has been brought forward in Mississippi by a man who was implanted with Ventralex mesh and suffered serious injuries. He also required revision surgery to fix the problem.
Other hernia mesh manufacturers have also been the subject of product liability lawsuits. Johnson & Johnson and subsidiary, Ethicon, Inc., are defendants in over 400 hernia mesh lawsuits regarding Physiomesh Flexible Composite mesh implants. These cases have been consolidated in a case before the U.S. District Court, Northern District of Georgia. Another multidistrict case has been brought against Atrium Medical’s C-Qur hernia mesh implant.
Defective medical devices can cause serious injury. It is important to obtain the right representation as soon as possible to protect your health and wellbeing. If you believe you have been injured by a defective medical device, contact one of our Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler for a free consultation. Call us at 215-569-4000 or contact us online. We are centrally located in Philadelphia, Pennsylvania, and we represent clients throughout the surrounding areas.