Over the past six years, the U.S. Food and Drug Administration has received over 4,000 reports of patients suffering complications from vaginal mesh implants used to repair pelvic organ prolapse. The agency responded with a transvaginal mesh FDA warning in 2008 and 2011.
Approximately 75,000 women each year undergo surgery to implant trans vaginal mesh devices in order to correct pelvic organ prolapse. The condition, in which organs fall into the pelvic cavity, affects nearly 1 in 10 women after childbirth, hysterectomy or menopause.
Unfortunately, some studies have shown that more than 15% of women receiving these types of implants suffered complications within only 3 months of surgery. The problems can include mesh erosion through vaginal tissue, infection, bleeding, pain during intercourse or organ puncture.
Since the transvaginal mesh FDA warning was published, lawyers have been helping those women affected by these side effects file claims against the makers of these defective devices.
If you suspect you may have received an implant subject to the transvaginal mesh FDA warning, it is important that you speak with a lawyer as soon as possible to learn your legal options. You may be entitled to a substantial recovery.
The FDA first issued a warning about the transvaginal implanting of mesh devices to treat pelvic organ prolapse in 2008. By that time, they had received over 1000 reports of complications.
On July 13, 2011, a second transvaginal mesh FDA warning was issued. By then, the agency said they had received almost 2900 additional reports of patients experiencing problems with their vaginal implant mesh devices.
The 2011 FDA warning advised that patients undergoing pelvic organ prolapse repair with a surgical mesh could face a higher risk of serious complications than those undergoing alternative procedures.
Although surgical mesh has been used for decades, the transvaginal implant method is fairly new. Unfortunately, manufacturers failed to conduct extensive clinical trials of vaginal use of the devices as it was not required under the 510(k) FDA fast-track regulations.
Now, the manufacturers of these devices are facing thousands of lawsuits for the medical costs, lost wages, lost time with family, lost consortium and pain and suffering suffered by those women affected.
You and your family should not face the full burden of dealing with a faulty medical device or surgical procedure simply because of the negligence of a doctor or medical device company. A qualified lawyer can explain your legal options.
Lawsuits for defective medical devices like these can be complicated, time consuming and expensive legal matters. Therefore, it is important that you only trust a lawyer or law firm with extensive experience fighting large medical companies.
The mesh implant resource center works with only the top drug and device injury law firms in the country to make sure your case is handled properly and you recover quickly.
Contact us today for a confidential evaluation of your case. We are available 24 hours a day to answer your questions and provide help.