Hernia repair surgery is extremely common in the United States, with the U.S. Food and Drug Administration (FDA) reporting that over one million such procedures take place nationwide each and every year.
For many patients, this course of treatment involves the use of surgical mesh as a means of facilitating lasting healing, though there have been growing concerns about the safety of the Ethicon’s Physiomesh hernia repair products, which have been available on the American market since 2010.
Plaintiffs across the country have begun filing suit in order to secure compensation for the injuries and serious side effects they believe were directly caused by Physiomesh patches.
Key Facts About Physiomesh Hernia Repair Products
As described by the FDA, surgical mesh, including that used in hernia repair procedures, is designed to offer extra support to areas of tissue that have been damaged or weakened.
Physiomesh patches are comprised of fibers made from flexible plastic that are woven to create a mesh aimed at preventing internal adhesions while the surgical repair itself is given time to take root and become permanent.
While it has been suggested that the use of this type of mesh product has a strong track record of improving surgical outcomes, an increasing number of patients have stepped forward alleging that Physiomesh product, in particular, have the potential to cause serious harm.
Alleged Dangers of Ethicon Physiomesh
Since its introduction, Physiomesh patches have continued to garner negative attention, with growing legions of hernia repair patients reporting complications that include:
- Hernia recurrence
- Intestinal blockage
- Tissue adhesion
- Organ perforation
- Mesh contraction
- Renal failure
- Dental problems
- Chronic pain
- Necessity of potentially dangerous revision surgery
After data gleaned from German and Danish hernia repair registries revealed alarming failure and revision rates in patients implanted with Physiomesh patches, Johnson & Johnson’s Ethicon subsidiary initiated a voluntary removal of the product from the global market, instructing physicians everywhere to cease using the mesh altogether.
FDA’s 510(k) Approval Process Scrutinized
It is worth noting that Ethicon’s Physiomesh product was introduced to the American market pursuant to the FDA’s controversial 510(k) clearance process, which allows for approval of medical devices deemed “substantially equivalent” in effectiveness and safety levels to products already available.
Critics assert that this program essentially permits manufacturers to sidestep all-important clinical trials and monitoring designed to keep dangerous devices away from patients, even in cases where specific concerns have been raised about product safety prior to initial market appearance, as had occurred with regard to Ethicon’s Physiomesh.
Current Status of Physiomesh Litigation
Physiomesh lawsuits have already been filed in multiple states, and the first trial on this type of mesh-related injury claim is slated to begin later in the month.
Alarm bells have also been sounded with regard to other hernia mesh products on the market, including the C.R. Bard Composix Kugel Mesh, Atrium C-QUR and Omega-3 mesh devices.
While the eventual scope of hernia mesh litigation remains to be seen, attorneys continue to review potential cases to determine how best to proceed on behalf of patients suffering with what can be life-changing side effects.
Our attorneys are committed to investigating the facts of your hernia mesh claim and fighting for the compensation you deserve. To begin the process of holding the makers of dangerous medical devices accountable, contact us today.