Vaginal mesh devices like the GYNECARE PROLIFT, manufactured by Johnson & Johnson subsidiary Ethicon, were intended to help women suffering from weakened vaginal muscles that led to conditions such as stress urinary incontinence and pelvic organ prolapse. The design was based on a type of surgical mesh used to strengthen the abdominal muscles of patients who suffer from hernias.
Unfortunately, the concept of vaginal mesh was better on paper than in practice. Thousands of women underwent vaginal mesh surgery only to sustain permanent injuries.
What Went Wrong?
Vaginal mesh surgery involves implanting the device through an incision in the vaginal wall, to help hold pelvic organs in their proper places. Devices like the GYNECARE PROLIFT turned out to be poorly designed, and caused women to experience injuries including organ perforation, internal bleeding, nerve damage, and chronic pain, because it turns out that in addition to questionable design, the mesh devices are highly incompatible with the pelvic region of a woman’s body.
In an effort to get relief from their suffering, many women have undergone multiple surgeries to remove the vaginal mesh devices from their bodies, only to discover that the mesh cannot be completely removed, causing permanent injuries. Further surgical complications have actually worsened symptoms for a large number of these women, causing the incontinence or organ prolapse to become worse than it was before the initial surgical procedure.
As a result, women have chosen to exercise their legal rights by filing lawsuits against various medical device manufacturers that developed and sold vaginal mesh products. These devices were not thoroughly tested, and were approved by the U.S. Food and Drug Administration through a loophole known as 510(k), which allows medical devices deemed “substantially similar” to existing devices to bypass critical testing, including clinical trials on human subjects.
To date, there have been several high-profile vaginal mesh trial verdicts in favor of plaintiffs, which have resulted in significant compensatory damages for medical expenses, as well as extensive pain and suffering.
Consult with a Physician if You Are Experiencing What Could Be Vaginal Mesh Failure
Contending with stress urinary incontinence and pelvic organ prolapse is difficult, especially when a procedure as highly touted as vaginal mesh surgery does not accomplish what it promised to do.
If you have undergone vaginal mesh surgery and your symptoms have not gotten better, it is important to contact your physician immediately. The sooner vaginal mesh failure is addressed, the more likely you will be able to minimize the degree of injury you experience. Moreover, if you feel you have grounds to sue Johnson & Johnson for the injuries you’ve suffered as a result of implantation of a GYNECARE PROLIFT vaginal mesh device, you should contact an experienced personal injury lawyer to help you through the process.