FDA links surgical mesh implants to complications

Though Johnson & Johnson is in the midst of several products liability-related lawsuits involving a mesh implant, the company apparently has no plans to recall the product. Instead, the company has decided to stop selling it. J&J reportedly sent a letter to the judges who are overseeing many of the patient lawsuits, stating that it would phase out usage of the mesh over a period of up to nine months.

The mesh is made of plastic and is used to support the pelvic wall in patients who suffer from pelvic organ prolapse. When a patient is afflicted with this condition, the bladder or reproductive organs slip out of place. During the past year, about 75,000 women have had this mesh inserted through the vagina instead of using an incision in the abdomen to insert the mesh.

Johnson & Johnson said that it is not recalling the mesh because it is safe, an assertion that others dispute. The company also stated that it is discontinuing the mesh due to “changing market dynamics.” However, reports from the U.S. Food and Drug Administration hint otherwise.

The reports from the FDA show that higher rates of bleeding, infection and pain have been associated with the implants. The FDA also stated that 10 percent of the women with the mesh implant said the implant eroded or the mesh became exposed within the first year after surgery. The FDA also apparently found that more than 50 percent of those women had to have at least one additional surgery to remove the mesh implant.

For many patients who had the mesh implanted, many say that J&J’s decision did not come soon enough.

Source: LA Times, “J&J to stop selling pelvic mesh implants tied to lawsuits,” June 5, 2012


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