Ethicon, a subsidiary of Johnson & Johnson, has issued a voluntary recall of ETHICON PHYSIOMESH Flexible Composite Mesh following two studies that found patients implanted with the mesh had a higher risk of hernias re-opening and requiring additional surgery. The company states that it believes the higher rates of revision surgery to be a "multifactorial issue" but has yet to pinpoint the factors causing the product's failure. In addition to the Physiomesh problem, Johnson & Johnson is facing thousands of lawsuits related to its vaginal-mesh inserts.
What is ETHICON PHYSIOMESH and What Does it Do?
Physiomesh flexible composite is a synthetic surgical mesh used in laparoscopic ventral hernia repairs. Hernias occur when some form of tissue is squeezed through an opening in muscle or connective tissue and ventral hernias occur in the abdominal/ventral wall. Unfortunately, a hernia is not a type of injury that can heal over time by itself, meaning that some form of medical intervention is usually required. Laparoscopic ventral hernia repair is a surgical procedure to fix tears or openings in the abdominal wall using small incisions with laparoscopes (long fiber optic cables) and a screen or mesh patch is attached to secure the abdominal wall. Surgical meshes help support these weakened areas after surgery; meshes can be processed animal tissue or synthetic, as well as absorbable, non-absorbable, or a mix. Ethicon Physiomeshes are synthetic and non-absorbable, making them permanent additions to the body. As with any physical implant, surgical meshes can have side effects, some of the worst being pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration, and mesh shrinkage. Many instances of complications related to hernia repair with surgical mesh have been reported to the FDA, leading to recalls of some products.
What should you do if you have had hernia repair with ETHICON PHYSIOMESH Flexible Composite Mesh?
Surgical meshes are used in hernia repair in part to lessen the chance that an additional procedure will be needed. If you have had laparoscopic ventral hernia repair with Physiomesh flexible composite or have had the surgery but are not aware of the product used, consult your doctor.