Applications of Transvaginal Mesh Implant
Women’s pelvic organs often drop, fall, bulge or prolapse into the vaginal wall when the muscles become weak or are over-stretched from childbirth, pregnancy or surgeries such as a hysterectomy. The mesh implant is used to repair the prolapse under the idea that the cells surrounding the implant will grow into it, holding the prolapsed organs in place. Women may also have a transvaginal mesh implant if they suffer from stress urinary incontinence which is an involuntary loss of urine occurring during physical activities, or coughing, sneezing or laughing. The implanted mesh works as sort of a hammock which supports the prolapsed organs.
Side Effects of the Transvaginal Mesh Implant
Initially the mesh implant appeared to have a much better success rate than the more traditional surgical methods, however adverse effects began to be reported following mesh surgeries. The most serious side effects were found to be vaginal mesh erosion or vaginal mesh shrinkages. The erosion of the mesh patch was found to lead to serious and even fatal infections, further pelvic organ prolapse, urinary incontinence or can necessitate further surgeries to correct the problem. These dangerous side effects were brought to the forefront when a large number of women participating in a clinical trial suffered varying levels of vaginal mesh erosion within three months of receiving the device. The trial showed that at least ten percent of the women experienced some level of mesh erosion within a year of the surgery.
Transvaginal Mesh Lawsuits
As of this November, 2011, over 4,000 women have experienced moderate to serious problems associated with the transvaginal mesh implant in the past four years and it is expected that more will come forward. Those who file a surgical mesh lawsuit may be able to collect damages for the necessary additional surgeries or surgical revisions, prior out of pocket medical, surgical and hospital expenses, damages for physical pain suffered, emotional distress endured and lost wages due to their inability to work.
Transvaginal Mesh vs. Traditional Surgical Methods
The FDA stated in their 2011 warnings that there was no conclusive evidence which proved that transvaginally placed mesh in POP repairs were any more effective than a traditional non-mesh repair and that the use of the mesh implant could additionally expose the patients to a greater risk. Following that warning a meeting of the Obstetrics and Gynecology Medical Device Advisory Panel was convened by the FDA. A majority of the panel agreed that the safety, effectiveness and benefits of using transvaginal mesh devices in POP and SUI surgeries were not well-established and required long-term follow-up of patients. The FDA proposed at this time to reclassify the transvaginal mesh device from a Class 2 medical device to a Class 3 medical device which would effectively render it ineligible for the less stringent FDA approval protocols and subject them to the necessity of further human trials prior to FDA approval.
More Women Seeking Recourse
Johnson and Johnson, one of the manufacturers of transvaginal mesh, most specifically the Gynecare Prolift, continues to be named in lawsuits which allege their mesh implant left them with painful—and permanent—injuries. Most recently a lawsuit was filed by a 46-year-old woman from South Dakota who received the transvaginal patch in 2006 or repair her pelvic organ prolapse. Since the initial surgery the woman has suffered constant pain, infections and urinary complications—and has undergone twelve additional surgeries with no relief.
In her mesh patch lawsuit, the South Dakota woman—as well as other plaintiffs—claim the device was not subjected to adequate testing prior to when doctors began using it in pelvic organ prolapse surgeries and that FDA clearance was not received for use of the mesh in POP surgeries until 2008, meaning it could have been sold without proper FDA clearance. The transvaginal mesh devices were approved for POP surgeries under the current FDA 501(k) approval process. This is a process reserved for devices which are considered only “moderate risk,” and does not require those devices to undergo human clinical trials prior to approval. It is now being suggested that the transvaginal mesh devices should be subject to the more stringent Class III FDA approval process which requires that the device be tested on humans prior to approval.
The Scope of the Problem
Over 70,000 women are believed to have received the transvaginal mesh patch just in the past year, therefore additional injuries are likely to surface. Attorneys throughout the United States report receiving a high volume of calls from women who suffered complications following their transvaginal mesh patch surgery. Over six hundred transvaginal mesh lawsuits are currently pending, although none of them have reached the trial stage. Johnson & Johnson was named in nearly half of those complaints, and American Medical Systems, C.R. Bard and Boston Scientific have also suffered under the complaints.
Your Legal Options and Rights
The law firm of Sullo & Sullo, LLP is currently investigating potential lawsuits among women who have experienced injuries following a transvaginal mesh surgery. You may be eligible to seek recovery for your specific physical injuries, medical bills, pain and suffering, lost wages as well as compensation for future surgeries which may be required to alleviate the damage caused by the mesh product. If you experienced any adverse symptoms following a surgery which utilized the transvaginal mesh patch, we would like the opportunity to evaluate your case and determine whether you are eligible to engage in a lawsuit against the manufacturers of the transvaginal mesh device. We are highly experienced and extremely knowledgeable regarding the facts of the transvaginal mesh and its history with FDA approval. Our attorneys look forward to discussing your case with you—we offer you compassion, professionalism and an excellent track record of success.
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