Pelvic mesh products have been used in recent years to treat women’s health problems. These products were originally used to treat pelvic organ prolapse, which is when the bladder or other reproductive organs slip down into the vagina. The pelvic mesh, intended to strengthen the pelvic wall, has been linked to injuries among patients in New Jersey and elsewhere. These injuries have spawned numerous product liability claims. One suit is ongoing in New Jersey.
In response, Johnson & Johnson plans to stop selling surgical mesh implants. However, the company denies the product is dangerous and insists upon the safety of the surgical mesh product. It also says it is not recalling the mesh; it is simply planning to stop selling it. The company will phase out four mesh products over the next three to nine months.
Approximately 75,000 women underwent prolapse surgery last year alone to have the mesh inserted through the vagina. Some women choose a similar surgery in which the mesh is inserted through the abdomen; however this method is less common. The Food and Drug Administration asserts that in 10 percent of cases, erosion or exposure of the mesh has occurred within 12 months after surgery. Many times, this has required two or three follow-up surgeries to correct.
In January, the FDA ordered Johnson & Johnson and five other mesh makers to track the number of complications occurring with their mesh products through rigorous scientific studies. However, faced with incurring the costs of the studies, J&J has said it expects the FDA to waive this requirement after it has stopped selling the product.
It remains to be seen how the FDA will respond or whether the company’s action might help prevent further lawsuits for product liability in New Jersey and elsewhere.
Source: Philadelphia Inquirer, “J&J to stop selling pelvic mesh tied to lawsuits,” Matthew Perrone, The Associated Press, June 5, 2012
