Johnson & Johnson is facing a new vaginal mesh lawsuit from an Alabama woman, claiming major injuries that allegedly resulted from the medical device.

The woman claims that as a direct result of the product’s defective design, she had to contend with major complications that required further medical care.

Plaintiff Deborah H. is filing this vaginal mesh lawsuit after being implanted with Johnson & Johnson subsidiary Ethicon Inc.’s Prolift System vaginal mesh product. Soon after having this device implemented, Deborah claims that she suffered avoidable injuries and that the device poses dangerous risks to thousands of potential patients.

According to her vaginal mesh lawsuit, Deborah had the device implanted on March 03, 2011 to treat her pelvic organ prolapse (POP). This is a common condition that vaginal mesh is recommended for, with the other major condition being in stress urinary incontinence (SUI).

Both of these conditions are often brought on by some form of physical trauma like child birth, from which the body was unable to fully recover. When these devices were first brought to market, numerous women rejoiced as they now had a discreet way to treat such personal medical conditions.

However vaginal mesh has been associated with a number of severe complications over the years including: mesh tearing, infection, organ perforation, pain, and complete device failure.

Vaginal Mesh Lawsuit Allegations

These devices would ideally keep the patient’s pelvic organs in place, along with allowing the patient to control their bladder. Deborah had these hopes for the Prolift System, as her physician recommended the product after reviewing Johnson & Johnson’s advertisements.

However, it was not long after the vaginal device was implanted that Deborah started experiencing adverse mesh complications. Among these complications include severe physical pain and permanent injury from the surgical sight.

Even though Deborah is contending with these complications, she claims that she never would have had to suffer these injuries if she had known of the side effects. There were no warnings or indications on the product’s label, or from Johnson & Johnson, to warn Deborah against the potential side effects of the vaginal mesh.

Like many vaginal mesh systems, the Prolift System had been approved by the FDA 510(k) policy that had allowed it to be propelled into the market. Under that particular rule, medical devices can be quickly approved for the market without preclinical studies as long as it proves to work at an equivalent level with an already released similar product.

According to Deborah’s vaginal mesh lawsuit, this provision resulted in limited data regarding the safety and efficiency of the product. Deborah further alleges that Johnson & Johnson knew of these risks, but had chosen not to warn consumers against these side effects.

Deborah insists that she never would have agreed to use the Prolift System, if she had known the risks associated with the device. So for being allegedly responsible for manufacturing, selling, and distributing a dangerous product, Deborah is filing a vaginal mesh lawsuit against Johnson & Johnson.

The Vaginal Mesh Lawsuit is Case No. 3:15-cv-08348-MAS-LHG, filed in the U.S. District Court of New Jersey.