Have you been using Transvaginal Mesh?
If you have tried in in the past or still using it, you might want to read on.
Recent Transvaginal Mesh Lawsuits
The Federal Food and Drug Administration was created to protect consumers against harm or injury from food and drugs or medical devices. However, it appears as if they did not require significant testing before they gave their approval to these transvaginal mesh devices. After being on the market for only three short years, the very first device that was approved was recalled. There were reports that it was not functioning as was fully intended and was resulting in a much higher than expected rate of vaginal erosion, according to the FDA. As a result, there have been a number of transvaginal mesh lawsuits filed against these manufacturers.
In 2008, a warning regarding the potential complications of transvaginal mesh devices was issued by the FDA. However, their claim was that the complications were rare. In 2011, this warning was amended to state that complications were actually not rare and these transvaginal mesh devices actually put patients at a much higher risk of complications and that these devices were no more effective than any of the other procedures available.
In 2012, thirty-four pelvic organ prolapse mesh manufacturers and seven of the stress urinary incontinence mesh manufacturers were told to do 109 post-marketing studies in order to examine the safety and potential for adverse events that were related to their devices. Despite the fact that these difficulties are known, the devices have not been recalled as of right now by the manufacturers or the FDA.
There have been thousands of transvaginal mesh lawsuits filed by women and the families of these women against the manufacturers of these transvaginal mesh devices. There are many manufacturers of these devices and not all of them have been named.
Companies Named in the Transvaginal Mesh Lawsuits
Following is a list of the companies that have been named in these transvaginal mesh lawsuits.
- Boston Scientific
- Cook Medical, Inc.
- American Medical Systems (a subsidiary of Endo)
- Coloplast Corp
- R. Bard
There have been over sixty thousand different transvaginal mesh lawsuits that have been combined into federal multi-district litigations, or MDLs, in the US District Court for the Southern District of West Virginia. This isn’t including lawsuits filed elsewhere. One MDL suit has reached a settlement outside of the courtroom by Ethicon, which is a Johnson and Johnson subsidiary.
There are other states and federal district courts that are currently supervising thousands of transvaginal mesh lawsuits against these manufacturers.
History of Transvaginal Mesh Lawsuits
Following is a bit of the history of the transvaginal mesh lawsuits. This list includes cases that have either already gone through trial or been settled out of court.
- 2012: C.R. Bard demanded by jury verdict to pay $5.5 million to a couple in California
- 2013- Ethicon/Johnson and Johnson by jury verdict demanded to pay $3.35 million to a woman in New Jersey
- 2013- C.R. Bard demanded via jury verdict to pay $2 million to a woman in West Virginia
- 2013- Bloomberg News announced that some of these manufacturers were in discussions to reach a settlement out of court for up to $30 thousand per claim. However, this agreement has not been officially announced.
- 2014- An agreement was made by American Medical Systems to settle around 20,000 cases for $830 million- however, if more cases are added, that total will increase.
- 2014- An agreement has been made by Coloplast to settle around 400 lawsuits for about $16 million- but the parties have been sworn to secrecy.
Attorneys that are representing the victims in these cases are making claims that the manufacturers have been negligent. Following are some of the areas that negligence is being claimed.
First of all, these companies had full knowledge of the safety and efficacy of these problems and knowingly misled the FDA, the public, and medical community regarding the safety and efficacy of these devices.
Secondly, the manufacturers of these transvaginal mesh devices did not conduct significant clinical trials in order to determine whether or not they were safe and effective for treating pelvic problems in women.
The transvaginal mesh manufacturers did not establish safe, effective methods for removing these transvaginal mesh devices.
Finally, the manufacturers of these transvaginal mesh devices hid their knowledge that these devices could result in permanent and even debilitating injuries, including death, even though they had a legal and moral obligation to release such information.
At this time, there have been over forty products named in the current transvaginal mesh lawsuits and many more are expected to be filed as more women experience issues and come forward.
Information about Transvaginal Mesh Devices
Since the mid-1990s, these transvaginal mesh devices have been used to treat issues of pelvic organ prolapse and stress urinary incontinence in women. These devices were supposed to be an improvement of the methods used in the past. However, instead results have been thousands of serious adverse reactions, including permanent injuries and even death.
This category of medical devices includes “slings” which is a net-like mesh that is implanted in order to suspend the bladder or uterus. This sling is implanted “transvaginally” or through the vagina instead of through traditional abdominal surgery.
Transvaginal mesh is very similar to the mesh that was used to repair hernias and other tissues that was original approved by the FDA under 510(k) status. This status allows the manufacturer to avoid having to go through rigorous and costly studies in order to prove safety and effectiveness of a product. The 510(k) program only requires that a manufacturer make a claim that the device is not substantially different than the other devices that are already on the market.
The very first transvaginal mesh device was approved based on the similarity to the medical mesh products already on the market used to repair hernias and other procedures. The transvaginal mesh devices approved after that were based on the design of the very first vaginal mesh product- which had been recalled only three short years after it was approved.
The 510(k) process of the Food and Drug Administration could be at least partially to blame for the thousands of serious adverse events that have been caused as a result of transvaginal mesh. In 2008, the Food and Drug Administration released a statement that the procedures using transvaginal mesh did not appear to be any more effective and were actually much more likely to increase the risk of Serious Adverse Events, or SAEs. Even with this opinion and the objections of many medical groups, these transvaginal mesh devices have not yet been recalled.
There have been thousands of lawsuits that have been filed by the victims and the families of those victims that have been injured or killed due to the implantation of transvaginal mesh products and this number is expected to reach over 100 thousand.
Adverse Events and Complications
The Food and Drug Administration defines a serious adverse event, or SAE, as a medical event that is a result of a medical product that results in the patient being hospitalized, birth defects, permanent injuries, or even death. The transvaginal mesh devices have required revision surgery and have resulted in permanent injury, and even death, to many victims, resulting in a number of transvaginal mesh lawsuits
Major Serious Adverse Events Caused by Transvaginal Mesh
There have been several serious adverse events that have been caused by the implantation of transvaginal mesh devices. These SAEs include the following:
The transvaginal mesh devices have eroded through the vaginal wall, which can result in perforation of organs. This results in scarring of the vaginal wall, shrinking of vaginal tissues, and even severe bleeding and/or pain. Erosion can require multiple surgeries in order to correct the damage- and in some cases, the erosion caused by transvaginal mesh could be permanent.
Perforation of Organs
When the transvaginal mesh begins to erode, it can result in the vagina or other organs to become perforated. This can result in intense pain and/or bleeding and causes a significant increase in the risk for developing an infection. Perforation of organs typically requires surgery to correct- however, in some cases, the damage is likely to be permanent.
Surgery to Correct Transvaginal Mesh Damage
Corrective surgery or even surgeries could be required in order to repair the damage that is caused by transvaginal mesh that has perforated or eroded could be required in order to address the original issue of pelvic organ prolapse or stress urinary incontinence that was not resolved by the transvaginal mesh . In some cases, one surgery will be able to correct any damages caused. However, in some cases, multiple surgeries will be required. Every surgery opens the patient up to more pain and an increased risk of infection, scarring, and excessive bleeding.
Death caused by Transvaginal Mesh Devices
In some cases, women have died due to the perforation of their organs caused by erosion of the transvaginal mesh device. Additionally, the risk of death is increased by excessive bleeding or infections caused by the device.
Other Potentially Debilitating Effects
There are a few other effects that can potentially be caused by transvaginal mesh. These effects are debilitating, but are not life-threatening.
- UTIs which become chronic and require specific medications.
- Scarring of the vagina, which can lead to thickening of the vaginal walls and therefore pain and difficulty with sexual intercourse.
- Nerve damage to the vagina and the surrounding abdominal or pelvic area that could result in significant pain or even a loss of sensation.
- Emotional disorders as a result of the pain, multiple surgeries, or even permanent disability due to damage.
If you have had a transvaginal mesh implant and are experiencing problems, you should consider speaking with an attorney to find out more about your rights. In most cases, an injury attorney will review your transvaginal mesh lawsuit for free and if you chose to move forward, you are not required to pay for representation unless you win your case.