In May 2016, Ethicon voluntarily recalled their surgical mesh product, Physiomesh over serious health complications and the high recurrence rate of hernias requiring revision surgery. Ethicon, a subsidiary of Johnson & Johnson, sent a letter to surgeons and operating room supervisors when the results of a several unpublished European studies showed a higher than average rate of serious complications as compared to other surgical mesh products. The U.S. Food and Drug Administration (FDA) had previously expressed concern over the potential complications from the Physiomesh Flexible Composite Mesh.
Hernia surgery is one of the most common current applications of surgical mesh, but it can also be used in organ prolapses in the pelvic region as well. While hernias can occur in both men and women, organ prolapse is most common in women over 50 who have had at least one child via vaginal birth.
Physiomesh complications often require additional treatment, including surgery. The more severe complications include the following:
- Bulging & organ disruption
- Severe pain in pelvic, genital or groin region
- Pain during sexual intercourse (dyspareunia)
- Recurrence of hernia
- Scarring and nerve damage
- Degrading of the mesh
- Infection, including sepsis
- Bowel obstruction caused by adhesion formation
Several hernia mesh lawsuits have been filed over failed Physiomesh hernia mesh products alleging Ethicon failed to make a safer mesh product. Behind these allegations are concerns about inadequate research and the failure to warn medical professionals regarding the risks of the product.
If you or a loved one suffered complications after an Ethicon hernia mesh device was used to repair a hernia, please call one of our experienced medical malpractice lawyers at 1-800-777-4081. You may be entitled to compensation for pain and suffering, medical costs and other losses.