Ethicon Hernia Mesh Recalled
Johnson & Johnson’s Ethicon unit voluntarily recalled its Ethicon Physiomesh® Flexible Composite hernia mesh in May 2016. J&J’s review of unpublished hernia databases in Germany and Denmark revealed that Physiomesh® failed at higher rates compared to other, similar hernia mesh products.
What is Ethicon Physiomesh?
Ethicon’s Physio Hernia Mesh is a flexible product made of polypropylene (plastic) woven into a fabric and laminated. Like all hernia repair meshes, it is used to repair the hernia by reinforcing the abdominal wall; it is also intended to prevent future hernias from occurring.
Hernia mesh became a popular hernia treatment in the 1980s, and the FDA estimates that by the year 2000 90% of hernia surgeries involved the use of hernia mesh.
Ethicon Physiomesh® Flexible Composite hernia mesh was approved for use in hernia repair in April, 2010, using the FDA’s 510(k) approval process. 510(k) clearance meant that Physiomesh® did not have to have FDA review or new safety studies, because Johnson & Johnson claimed that the product was “substantially similar” to Proceed hernia mesh, another product manufactured by Ethicon. Proceed hernia mesh was recalled by Ethicon a few months later in October of 2010 for delamination (separation into layers after implantation).
Ethicon Physiomesh Complications
The following complications have been reported in patients implanted with Ethicon Physio Hernia Mesh:
- Tissues that sticks together (Adhesions)
- Blockage of large or small intestine (Obstruction)
- Mesh migration
- Bacterial infection
- Hernia recurrence
- Additional surgery to treat hernia recurrence
What Can You Do?
If you or a loved one has been injured after being implanted with Ethicon Physiomesh® Flexible Composite hernia mesh, you may have a claim for damages. Contact the defective medical device attorneys at Thornton Law Firm for a free, confidential evaluation of your legal rights at 1-888-341-1405. Or tell us your story here for a free and thorough evaluation of your legal rights.
Trust our Massachusetts defective medical device attorneys to help
Contact Thornton Law Firm’s drug and medical device Attorney Marilyn McGoldrick online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts defective drug and medical device litigation. The consultation is completely confidential. We offer a fair and accurate assessment of your case.