Ethicon, a subsidiary of Johnson & Johnson, issued a recall of Physiomesh, a flexible, composite mesh used in minimally invasive hernia repairs, several months ago. The mesh appears to have a higher than normal risk of failure, leading to higher revision rates. Ethicon continues to maintain that they did not recall the surgical mesh, merely “pulled it from the market.”
Whatever language the company now chooses to use, an Urgent Field Safety Notification was sent out to Operating Room Supervisors, Chiefs of Surgery and Materials Management Personnel in May 2016, which clearly used the word “recall” in connection with the mesh.
Even so, the FDA has yet to list Physiomesh in their recall section. The mesh was recalled—or pulled from the market—after discrepancies between Physiomesh flexible composite mesh and other meshes used in laparoscopic ventral hernia repair were found in a review of unpublished data from European registries.
What Does Ethicon Say is Wrong with Physiomesh?
Ethicon has been unable to pin down the reason for the higher revision rates among patients implanted with Physiomesh, however has vaguely attributed the problems to “product characteristics, operative and patient factors.” Interestingly, despite a high rate of patient and surgeon complaints regarding Physiomesh over the past few years, Ethicon refused to consider a recall even after the independent studies revealed high rates of complications associated with the hernia repair mesh. It is likely this reluctance had something to do with company profits, as Physiomesh remained on the market until Ethicon’s new product, Physiomesh Open, gained FDA approval, and could take the place of Physiomesh.
Physiomesh Approved Under Controversial FDA 510(k) Program
Many people have followed the lawsuits filed against the manufacturers of transvaginal mesh, which is made of the same polypropylene as the Physiomesh hernia repair mesh. The FDA originally approved Physiomesh in 2010, via the agency’s controversial 510(k) program. This program fast-tracks medical device approval by requiring only that the manufacturer show the new device is substantially similar to another device already on the market. Ethicon is currently facing thousands of lawsuits from women who were injured by transvaginal mesh and bladder slings made from polypropylene.
Coating on Physiomesh Meant to Reduce Problems
Due to the problems associated with the polypropylene transvaginal mesh, the company added an absorbable film coating to both sides of the polypropylene. This coating was meant to minimize the problems caused when the material comes into direct contact with human tissue. The coating on Physiomesh was intended to prevent the bowel from direct exposure to the polypropylene, preventing the mesh from perforating the organ (as it has done to many women implanted with polypropylene transvaginal mesh).
Unfortunately, the coating prevented Physiomesh from staying where it is meant to stay, leaving it to float and move around in the abdominal cavities of Physiomesh recipients. Physiomesh is also a much lighter grade of polypropylene, which, rather than resulting in fewer complications, has resulted in more complications as the lightweight mesh tears apart inside the patients.
Some of the most common Physiomesh patient complications include the following:
- High rates of bowel obstructions;
- Seromas (accumulation of fluids in a tissue or organ);
- Mesh failures, and
Studies Associated with Physiomesh
In a March 2016 study, twenty-five patients were implanted with Physiomesh, while another twenty-five were implanted with Ventralight mesh. Within six months of the procedures, one-fifth of those implanted with Physiomesh experienced a recurrence of their hernia, while none of those implanted with Ventralight experienced a recurrence.
In another study published in August 2016, Physiomesh was compared to two other types of hernia mesh products. The study concluded that the use of Physiomesh resulted in less tissue integration (therefore higher rates of revision), and the development of more seromas. Other studies have resulted in similar outcomes.
Getting the Legal Assistance You Need
If you have suffered injury after being implanted with Physiomesh Surgical Hernia Mesh, you need an experienced legal advocate in your corner to help you determine the best course of action. The specific facts related to your Physiomesh injuries will determine whether you are entitled to compensation from Ethicon and Johnson & Johnson. Calling an attorney from Martinson & Beason could be extremely beneficial to your current situation, and to your future. Our attorneys have extensive experience regarding dangerous medical devices, and can offer a knowledgeable assessment of your injuries. Don’t wait—Call Martinson & Beason today.