A hernia mesh recall has been issued by Johnson & Johnson subsidiary Ethicon due to “higher than average rates” of hernia recurrence and re-operation in patients who received Ethicon’s Physiomesh Flexible Composite Mesh product.
The Physiomesh recall was announced in May 2016 in an Urgent Field Safety Notice sent to surgeons and hospitals worldwide.
In the notice, Ethicon said it issued the voluntary Physiomesh recall following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two large independent hernia registries known as the Herniamed German Registry and Danish Hernia Database-DHDB. Analysis showed that patients in these registries who received Physiomesh had higher than average rates of hernia recurrence and re-operation compared to patients who received other types of hernia repair mesh.
Ethicon urged health care practitioners to continue to follow patients who were treated with Ethicon Physiomesh in the usual manner.
HERNIA MESH PROBLEMS
Surgical hernia mesh like that included in the Physiomesh recall is inserted into patients during hernia repair surgery to support weakened and damaged tissues and to allow tissue to regrow and strengthen in these weakened areas.
Typically, surgical meshes are made of animal tissue or synthetic material. Physiomesh is made from polypropylene — the same material used to make Ethicon’s transvaginal mesh and bladder slings, which have led to thousands of defective medical device lawsuits against the company.
The most common hernia mesh problems reported by patients include:
- severe pain,
- bowel obstruction,
- hernia recurrence,
- mesh migration,
- organ perforation,
- tissue perforation, and
- removal of what was intended to be permanent mesh.
PHYSIOMESH RECALL LAWSUITS
Since the Physiomesh recall was announced, several lawsuits have been filed by patients against Ethicon and Johnson & Johnson accusing them of defectively designing and manufacturing a product that did not work as intended.
Ethicon uses polypropylene or plastic material to make the base layer of Physiomesh. Unfortunately, when this breaks down, it can cause the hernia mesh to migrate and serious injuries may occur. Furthermore, the mesh was intended to be a permanent solution for hernia repair but some individuals are experiencing recurring hernia or revision surgery to correct the problems.
According to early Physiomesh lawsuits and investigations, neither doctors nor patients were warned about the risks of Physiomesh and now legal claims name the manufacturers as accountable for injuries sustained by those victims.
The first Physiomesh recall lawsuit is schedule to go to trial in January 2018.
If you or someone you know has been affected by the Physiomesh recall and sustained significant injuries as a result, you may have grounds to file a defective medical device lawsuit.
The experienced attorneys at Bradley/Grombacher have years of experience helping people who have been injured as a result of defective medical devices. Contact us today for a free case evaluation by filling out the form on this page.