In recent times, women suffering from Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) have sought respite from urine leakage, pain and other inconveniences with surgical indoctrination of the vaginal mesh device. While this has helped some to gain relief, many others have complained about an increment in their suffering even more than the actual pains they went to relieve, basically due to the synthetic slings.
As a consequence of chronic pain and lasting damage, many have opted to file a lawsuit in order to avenge the personal injury inflicted upon them. In case you are the one suffering from such a condition with this surgery as your last resort, it’s advisable to learn more before taking a viable decision.
What do I need to know on Trans-Vaginal Mesh?
The word trans-vaginal implies “passing through vagina” and ‘mesh’ refers to a bendable meshing of wires used specifically for surgeries. If you are asking what is transvaginal mesh is used to treat? It is used to treat a weakened pelvic floor muscles which may occur as a result of aging, childbirth, hysterectomy, obesity or other conditions.
There are basically two critical ailments associated with the same:
- Stress Urinary Incontinence (SUI): It refers to urine leakage during sneezing, coughing, running, exercising or any other physical activity.
- Pelvic Organ Prolapse (POP): This occurs when there is a sudden weakening or stretching of the tissues holding together the pelvic organs. When this happens, the organs prolapse and in most cases go past the vaginal opening. There is a good chance that more than one organ bulges out simultaneously. The uterus, bladder, the vaginal apex, the bowel and the rectum are few organs that are involved in this kind of pelvic disorder.
This results in ache, uneasiness and few other discomforting symptoms that require medical assistance to improve the agonizing condition or ease the suffering. Surgical implementation involves the passing of a synthetic mesh through the vagina before implantation, with an objective to strengthen the weakened pelvic floor muscles. Different medical device companies manufacture these meshes on approval by Food and Drug Administration (FDA). This may have been one of the biggest medical advancements of this generation, however, many women have suffered the opposite effect in recent times and it’s imperative to be aware of each and everything involved in such a surgery.
What are some of the complications with a vaginal mesh?
Transvaginal mesh complications can make it agonizing for women to walk, sit or have healthy sex life. Medical intervention is required to alleviate these complications, since it’s not possible to completely reverse the effect of vaginal mesh surgery. One may have to undergo multiple operations to completely remove the mesh, but that doesn’t guarantee total relief to the sufferer. Due to high rate of complications, FDA has issued an open public warning to the potential consumers and all the registered complaints are being investigated thoroughly.
According to FDA, the most common complications due to this surgical implantation include the following:
This is a visual illustration of a vaginal mesh implant inserted surgically.
- Vaginal infection
- Erosion through vaginal epithelium
- Urinary problems
- Recurrence of incontinence or prolapse
- Bladder, blood vessel and bowel perforation during insertion.
- Mesh erosion and vaginal scarring
- Shrinkage of Vagina
- Excessive vaginal drainage and discharge
- Discomfort and pain during sex
- Decrease in quality of life owing to frequent distress
Apart from all the complications caused by implanting the mesh, many women suffer from the injuries inflicted upon their organs during the process of implanting. These include perforation of blood vessels and bladder. The sling-shaped piece of synthetic mesh may leave an internal injury that aggravates over time. In order to counteract this, additional surgical methods such as hematomas drainage, IV therapy or blood transfusions are employed. This calls for added expenses apart from the mesh surgery, which can amount to huge numbers.
When is the mesh implant prescribed?
Millions of women round the world suffer from a common medical problem in the face of pelvic floor muscles weakening. vaginal mesh surgery introduced way back in the 90’s came as a relief to few, but it’s certainly not recommended for everyone. Weakened pelvic muscles are not the only criteria to get a prescription for this treatment.
Surgical Mesh Device
Most of the women who suffer from this disorder, gradually develop a more serious medical condition such as prolapse or incontinence. The point when the pelvic floor muscles are weakened to that extent; such that they are incapable of supporting organs like pelvic uterus and bladder, then a vaginal prolapse is said to have taken place. In this condition, the organs bulge out and slide down the vaginal wall resulting in utmost discomfort and pain. This is something any woman would want to get rid of at any cost and trans vaginal mesh surgery seems to be a viable option at the outset. On the other hand, prolapse can even cause Stress Urinary Incontinence.
On account of undermined support by the weakened pelvic floor muscles, the bladder might droop down and push against other organs. This leads to seepage of urine by uncontrolled activities such as coughing, laughing or sneezing. Exercise or any other physical activity may also bring about the incontinence.
The only quick and obvious way to cure this weakening is to strengthen or support the pelvic floor muscles and implantation of vaginal mesh seems to be an effective way to rectify the same. However, with all the negative feedback surrounding this procedure in the last few years, it would be hard to take a stand on this statement.
Who makes these vaginal mesh implants?
A transvaginal mesh implant is a sling shaped piece of synthetic mesh that is manufactured by Food and Drug and Administration (FDA) approved manufacturers. Owing to the recent complaints about the device, FDA has been strict in approving only those who conduct safety studies before launching the product in the market. The most commonly used slings are manufactured by C.R Bard, Boston Scientific Corporation, Johnson & Johnson and American Medical Systems.
Common brands include the following:
- Pelvicol Tissue
- Avaulta Plus Bio-synthetic Support System
- Elevate Anterior and Apical Prolapse repair system
- Pelvitex Polypropylene Mesh
- Advantage Sling System
What is the FDA doing about it and are there any warnings?
The Food and Drug administration came into action during the period when all the criticism against the vaginal mesh surgery got puffed up in between 2005 to 2007. FDA spread the word to all the doctors to take utmost care while performing this surgery and also make the patient aware of the complications they might encounter post-treatment. In spite of all these efforts, the complaints never stopped coming in and FDA had to issue a public safety warning.
They are investigating the root of this loophole, but to no significant result as of yet. Although the procedure has been in practice over a long time, the FDA has only taken a step towards alerting people of the side-effects, by issuing warning about the potential complications that may arise as a result of this surgical method. It was initially assumed to be an effective low-risk method of treating disorders like Stress Urinary Incontinence and Pelvic Organ Prolapse and owing to that belief; majority of women undergo the treatment every year to alleviate the uneasiness.
The number reached as much as 300,000 in 2010 with 30% debacle on charts. The trans vaginal mesh used for this implantation is similar to the one used in hernia repair surgeries, however, the thing hasn’t proved to be as thriving in the recent medical practices. As stated above, large numbers of women have suffered the opposite effect owing to the deficiency of extensive research and analysis before introducing this device in the market. This casualness and lack of assessment has cost many women their quality of life and majority of them have taken legal actions against the concerned authorities.
Over the years, the Food and Drug Administration hasn’t really been solid with their statements regarding this failure. In 2008, they issued a safety warning notice to inform all the potential patients that the complications do rarely occur, but they are likely to take place. In 2011, the FDA revised this statement and made the consumers aware about how these complications are frequently encountered. This came as a response to a bundle of complaints that was already piling up since 2005. Finally, they passed an order to all the mesh manufacturers to conduct a safety study before introducing the device in the market.
In spite of all these measures and strict approvals, the mesh continued to be a mess for thousands of women who have had the worst experience ever. As much as 10% of women start experiencing the complications within a year of the surgery.
The latest FDA activities in regulating this device:
|Oct. 2008||FDA post a public notice regarding the mesh that adverse reactions are "rare"
|Jul. 2011 ||FDA revises its position on the effectiveness of the mesh from "rare" to "not rare"
|Sept. 2011||FDA get the OBGYN Devices panel for a committee meeting.
|Jan. 2012||FDA request manufacturers. to do more postmark study based on a comprehensive panel review.
|Feb. 2012||FDA requests majority of the manufactures to study their brand further.
|Mar. 2013||FDA posts new information regarding the negative effect of the mesh for SUI
What type of pain are you suffering as a result of this surgical procedure?
Vaginal mesh device operation
Are you one of those tens and thousands of women who have been a victim, rather than a patient of transvaginal mesh surgery? Have you been experiencing unbearable pain ever since the operation? If yes, then just like me, you are facing serious complications that need to be rectified at the earliest. All sorts of legal assistance are available to you and one can easily recover their losses caused due to the following issues:
- Pain and discomfort in your abdomen
- Medical expenses that accrued as a result of this surgery. (This money can be utilized for additional surgeries to remove the mesh or alleviate the pain)
- Emotional grief and mental stress
- Degradation in quality of life
- Personal injury and uneasiness
- Incapable of having healthy sex
- Difficulty in carrying out house-hold activities
Unfortunately, just like you, many experts thought a surgical procedure on the pelvic will take care of the problem, and many other women are suffering from the complications as well. This is a kind of discomfort any woman would want to get rid of quickly and hence they take a decision to go for a surgery like this. Sadly, it doesn’t turn out the way one would have expected it to, and hence the suffering prevails. However, there’s no point in sitting back and distressing yourself even more, for the decision you took yourself. Hire a lawyer to build up a strong case in your favor and get back the money which you have spent to make things better and got the worse in return.
What lawsuits, settlements & updates are available for the vaginal mesh?
In the recent years, majority of women who have suffered from the complications of the vaginal mesh implants have filed lawsuits against the manufacturers of the sling that was employed during the operation. Most of these lawsuits are against the makers of the mesh and not the surgeons who implanted it. Obviously, the doctors relied upon the details provided to them by the FDA and the mesh manufacturers. That being said, many women have filed lawsuits against the manufacturers without suing their surgeons to the court of law.
A woman who registers a transvaginal mesh lawsuit is liable to recoup the expenses to compensate for her extra medical charges, pain and distress, personal injury or any other damage. The members of her family also have the right to retrieve the money on her behalf.
Many doctors did not believe me the amount of pain I was in. Getting legal representation was a necessity to help pay the mental anguish and additional surgery to remove the mesh. – Peggy
The Multidistrict Litigation in Federal Court has many consolidated lawsuits, some of which are listed below:
- Boston Scientific Corporation (Multidistrict Litigation No. 2326)
- American Medical Systems (Multidistrict Litigation No. 2325)
- Ethicon, Inc. (Multidistrict Litigation No. 2327)
- C.R. Bard, Inc. (Multidistrict Litigation No. 2187);
Cleared under the FDA 501 (K) process, which requires no testing on humans, this device was always going to be experimental in real practice. As it turned out to be, opting for such a surgery is tricky and the patients should assent to the same with the knowledge of potential risks and lack of long term results.
In case you feel that you have been robbed off your money because of the mesh surgical procedure and that has inflicted personal damage upon you, feel free to contact a lawyer in order to learn more about how to get your money back by filing a lawsuit with proper representation. Also, if your surgeon hasn’t referred your case to the FDA, do it yourself by making use of FDA’s reporting system. It encourages any such complaints and takes the matter quite seriously.
To learn more about this procedure, its risks and complications please check out this video: