Johnson & Johnson announced a desire to discontinue the production and marketing of a few of its vaginal mesh products. Johnson & Johnson claims that it is discontinuing these products worldwide because of bad public opinion about side effects. Our defective product attorneys are pleased to hear the news in light of the number of problems patients have experienced with the devices.
Vaginal mesh is a material used to help treat issues of weakness in the vaginal wall. Weakness can occur for a variety of reasons such as menopause, childbirth, or a hysterectomy. The vaginal mesh material is surgically implanted to help muscles that have begun to stretch or bulge. The proper medical term for these symptoms treated with the mesh is pelvic organ prolapse (POP).
The mesh is also used to target severe overactive bladder problems, which is also known as stress urinary incontinence. The typical overactive bladder symptom is a consistent urge to urinate, and other symptoms may include a dry mouth and dry eyes.
When these sorts of products first came to market, they did not even undergo clinical testing. Following numerous reports of serious problems with the mesh, the FDA said it might reclassify the mesh to a more stringent risk category. The higher threshold category would at least require companies to test the mesh in clinical studies before it goes to market.
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From 2008 to 2010, the FDA received more than 1,500 complaints of women experiencing problems with the mesh. That number is a startling five times greater than the incident rate from 2005 through 2007. So far, the FDA has only required manufacturers to begin some new tests to assess risks associated with the mesh.
According to an ABC news report, the vaginal mesh trouble with the FDA is only one of a multitude of recent problems Johnson & Johnson (J&J) has faced. Other issues range from feminine hygiene products to female lubricant products. In those instances, the FDA alleges that J&J did not pay adequate attention to consumer complaints. When prodded by the FDA, J&J said they would look into the matters promptly.
Other problems J&J is juggling with are not as serious as the vaginal mesh issues. Women experiencing problems with the implanted mesh report symptoms such as worsened incontinence (the inability to control urine), pain in the surgical region, and strained sexual performance. Some women also experience bleeding and other perceptible discomfort.
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When a patient undergoes an invasive surgery to treat a medical problem, he or she generally expects at least some improvement. Patients are done an injustice when they submit themselves to vaginal mesh surgery only to have increased problems with their bladder control problems. The trouble with the mesh is both physical and emotional.
Surgery is intimidating and patients who undergo an unsuccessful procedure may feel rightfully hesitant about future operations. In addition to the fear of further treatments, some women experience emotional turbulence because they are embarrassed by the symptoms the surgery was meant to fix. A constant or uncontrollable need to use the restroom is an understandably frustrating condition.
Women who have suffered as a result of the device, deserve legal recourse. In regards to vaginal mesh, J&J specifically addressed the more than 1,000 plaintiffs who have already filed suit in New Jersey and West Virginia. J&J reached out to the judges in these complex litigation cases to let them know the product was going to be removed from the market shortly.
Despite the fact that J&J claims holistic reasons for the withdrawal, some news outlets have speculated on the behavior. A Reuters article explained the situation, stating that it would be very difficult for J&J to convince a plaintiff, judge, or jury, that the cease production initiative was started entirely because the company simply decided to stop making the product.
Instead, commentators believe the company was probably making a strategic move to avoid more lawsuits or win some sympathy in the courtroom. Whatever the reason may be, our defective product attorneys are thankful to see the product leave the market before it injures more innocent victims. Based on company reports, the product should be off the market and headed out of the medical system within 120 days.