Johnson & Johnson was ordered by a Texas jury to pay $1.2 million to a woman who was injured after being treated for incontinence with one of Johnson & Johnson’s vaginal-mesh implants. Ms. Batiste obtained the first jury verdict against Johnson & Johnson in the vaginal-mesh litigation. Ms. Batiste suffered pelvic pain when the device eroded inside her.
There are over 12,000 lawsuits against Johnson & Johnson related to the mesh implants, including the slings, which are alleged to damage women’s organs and make sex painful when they begin to deteriorate.
Transvaginal mesh gained in popularity as a treatment option for Pelvic Organ Prolapse and Stress Urinary Incontinence in the mid-2000s. As that treatment option’s popularity grew, so did the manufacturers. There are over 30 manufacturers of these types of devices, including Ethicon (a division of Johnson & Johnson), CR Bard, American Medical System and Boston Scientific. The U.S. Food and Drug Administration (“FDA”) has ordered the manufacturers to study the rates of organ damage and complications linked to the implants. There are other, similar products that have been the subject of litigation as well, such as the Prolift implant which is implanted to support sagging organs.
The danger with these products comes when they begin to deteriorate. They can become infected or perforate organs. The danger has been known for quite some time. The FDA issued a Public Health Notification in October 2008 informing the public that it had received over 1,000 adverse event reports related to vaginal mesh. The FDA continued to be notified of problems and adverse events and released a public warning in 2011, http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm.
As noted by the FDA in 2011, mesh complications are not rare at all and include:
– Vaginal bleeding or discharge
– Pelvic or groin pain
– Dyspareunia (pain during sex)
– Urinary problems
– Organ perforation
– Recurrent prolapse
– Neuro-muscular problems
– Vaginal scarring and shrinkage
– Emotional problems
– Mesh “erosion” (really “exposure” or “protrusion”) through the vaginal wall
The FDA determined that the final symptom, mesh erosion, was the most common problem associated with mesh used to treat POP. The FDA concluded that, “Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not solve the complication.” Sadly, there has been no determination that vaginal mesh is even a better treatment option that more tradition, tried treatment options.
If you are having any of the symptoms and have a transvaginal mesh or sling, it is imperative that you contact a lawyer immediately and determine your rights.