Have you been injured by transvaginal mesh surgical implant? If so, you may be looking for transvaginal mesh safety information. There is growing concern after researchers found that the implants have a 15% rate of complications. The U.S. Food and Drug Administration (FDA) has received thousands of reports of adverse events. If you file a transvaginal mesh lawsuit in Texas, you may be entitled to compensation for your injury.
Do I Have a Transvaginal Mesh Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by transvaginal mesh surgery, you should contact our lawyers immediately. You may be entitled to compensation by filing a Transvaginal Mesh lawsuit.
Transvaginal Mesh Safety Information
October 2008, the FDA warned the public that they had received 1,000 reports of serious transvaginal mesh complications. The people had been suffering from urinary problems (pelvic organ prolapse or stress urinary incontinence) and been treated with transvaginal mesh. The incontinence problems were caused by a weakening of the abdominal muscles, which caused internal organs to protrude or press down on the bladder. The surgical mesh was implanted to help support the internal organs.
Transvaginal Mesh Complications
In the 2008 safety warning, the FDA warned that they had received reports of the following transvaginal mesh complications:
- Erosion of mesh through the vagina
- Bladder perforation during insertion of the mesh
- Blood vessel perforation during insertion of the mesh
- Vaginal scarring leading to significant decrease in patient quality of life
- Pain during intercourse
Study Ended Prematurely: 15% of Mesh Patients Suffer Complications
October 2010. Researchers studying the safety and effectiveness of transvaginal mesh were forced to abort their study prematurely, after finding alarming transvaginal mesh safety information:More than 15% of transvaginal mesh patients suffered a serious complication. The clinical trial involved 65 women who were suffering from Pelvic Organ Prolapse, a condition that frequently follows pregnancy, where a woman’s internal organs pushes against the walls of the vagina. The women were randomly divided; some underwent transvaginal mesh surgery, some underwent colpopexy, the traditional surgical procedure in which a woman’s ligaments are used to strengthen her muscles.
15% of the women who had received the transvaginal mesh implants suffered serious complications, and the implants were no more effective than the other type of surgery.
FDA Recommends Patients Use Alternative Treatments
In July 2011, the FDA announced that it had received 2,874 more adverse event reports, prompting the administration to issue another safety communication to follow up on the 2008 notice following 1,000 adverse event reports.
The adverse event reports included serious transvaginal mesh complications. The most common was erosion of the mesh into the vagina. Other complications included pain, bleeding, pain during intercourse that serious impacted quality of life, perforation of the bladder or other internal organ, continued urinary problems, and mesh shrinkage. Many women who have suffered from these complications have filed a transvaginal mesh lawsuit and are now seeking compensation for their injuries.
The FDA recommended that physicians should consider using other treatments for treating Pelvic Organ Prolapse and Stress Urinary Incontinence.
Transvaginal Mesh Should be Considered “Experimental”
In 2011 the Journal of Obstetrics and Gynecology Canada published a study that included new transvaginal mesh safety information. The researchers looked at data from several previously published safety studies, and concluded that “Until adequate effectiveness and safety evidence is available, the use of new transvaginal mesh devices for prolapse repair should be considered experimental and restricted to use in investigative trials.”
Transvaginal Mesh Recall
August 2011 two types of transvaginal mesh were recalled by the company following evidence that they were defective. The cited reason for the recall was that the devices “may exhibit low tensile strength between the needle and suture and lead to needle detachment during placement.” One of the biggest problems with the mesh is complications that occur during placement of the device, including laceration of the internal organs.
The recalled products were made by Boston Scientific Corporation and included the following medical devices:
- Pinnacle Pelvic Floor Repair Kit – Anterior / Apical STERILE
- Pinnacle Pelvic Floor Repair Kit — Posterior SERILE
After the company and the FDA announced the recall, an FDA panel convened to discuss whether the administration would require further action. The FDA determined that in the future, it would require pre-market testing of transvaginal mesh surgical devices.
Transvaginal Mesh May Become Class IIII “High-Risk” Medical Device
January 2012. The FDA had received a large amount of transvaginal mesh safety information. Many were concerned about the high rate of complications and failures. In response, the FDA met to decide whether to re-classify the implants as a “high-risk” Class III medical device, elevating it from a Class II device. Re-classifying a product as a Class III medical device compels manufacturers to conform to certain rules: they must conduct pre-market safety studies and post-market safety studies, and they must get FDA approval before they can sell their product.FDA Asks Manufacturers to Conduct Additional Safety Studies
January 2012. The FDA also decided that it would ask transvaginal mesh manufacturers to conduct dozens of post-market safety studies of the transvaginal mesh before they would be allowed to sell the products.
- To 33 manufacturers of surgical mesh, the FDA has asked them to complete 88 post-market studies
- To 7 manufacturers to single-incision mini-slings, the FDA has asked them to complete 11 post-market studies
Before the FDA decided to require manufacturers uncover more transvaginal mesh safety information, the medical devices were exempt from the normal requirements that medical devices go through rigorous safety studies before they are sold. Under the FDA’s 501(k) loophole, products that are similar to medical devices already on the market are not required to conduct safety studies or gain FDA approval. The manufacturers of transvaginal mesh reasoned that because their products were similar to hernia mesh, they did not need to gain FDA approval before selling their products.
How do I contact a Lawyer in Texas for a Transvaginal Mesh Lawsuit?
For a free consultation, please contact Collen A. Clark at The Clark Firm, LLP immediately. You may be entitled to compensation by filing a Transvaginal Mesh lawsuit.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more that 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact a lawyer in Texas for a free Transvaginal Mesh lawsuit review.