Transvaginal Mesh Lawyers Explain Dangers and Legal Issues Involved in Transvaginal Mesh Lawsuits
The transvaginal mesh attorneys at the Drug Law Center are taking on new cases involving anyone who has been seriously injured due to complications linked to transvaginal mesh products. It has been discovered that the manufacturers of these products knew of the potential risks and refused to remove their products from the market. Many women elected to have mesh devices implanted for the treatment of conditions such as pelvic organ prolapse and incontinence only for the devices to erode prematurely and cause debilitating injuries. We are committed to fighting for justice on behalf of the countless number of women who have been injured needlessly by these products.
The History of Transvaginal Mesh
Mesh products have been around for a very long time, but have only recently been used for the treatment of pelvic organ prolapse and stress urinary incontinence. The original surgical mesh that the idea of transvaginal mesh was based on was invented in the 1950’s to repair hernias. A special type of plastic called polypropylene is the material that is used to create the mesh and it is implanted through the vagina, giving it its name.
The original mesh material was used to treat pelvic organ prolapse and stress urinary incontinence beginning in the 1970s, but there was never a specific product solely designed for that purpose. It was implanted through the abdomen instead of through the vagina and it was cut specifically to size during the procedure. Seeing this as an opportunity, device manufacturers began to design special products that could be used exclusively in the treatment of these conditions.
It was when these devices were marketed and packaged in kits with special instructions on how to be implanted that complications began to arise. There was a high volume of procedures using the devices and they were never proven to be as safe as the traditional forms of mesh used during more traditional procedures. After hundreds of complaints were filed with the FDA, the agency began to study the material more closely.
After three years of investigating, the FDA released a statement claiming that complications linked to transvaginal mesh devices were not rare. In the same statement, it was made certain that the risks did not outweigh the benefits because the new procedures were no more effective than the traditional ones.
How the 510(k) Program Provided a Loophole for Transvaginal Mesh Products
Transvaginal mesh devices were able to make it to market without the typical FDA approval process by using the 510(k) premarket program. This program allows manufacturers to bypass some of the steps required to bring a device to market as long as it is similar to another device that is already on the market. The first device was approved under this program in 1996. Over the next several years, a number of products would make it to the market for the treatment of pelvic organ prolapse and stress urinary incontinence.
Only three years later, the first recall was issued, pulling the ProtoGen Sling off of the market due to worries over its safety. Despite this recall, more devices would make it to the market in subsequent years.
Complications Assocaiated with Transvaginal Mesh
By 2011, there were over 4,000 reports of adverse effects linked to transvaginal mesh products. The FDA originally reported that these effects were rare, but has since amended its statement. The most common complications follow below.
- Erosion of the mesh— when the mesh erodes, it can pass through the vaginal wall, causing severe injury to the pelvic organs. It is also extremely difficult for doctors to remove the mesh once it has eroded, leaving victims in severe pain for the rest of their lives and making it impossible to enjoy normal sexual function.
- Organ perforation— organ perforation may occur, resulting in internal bleeding, infection and other complications. Depending on the nature of the injuries, victims may experience life threatening complications.
- Damage to the nerves— damage to major nerves is irreparable and when erodes mesh severs a nerve, the results can be debilitating. From loss of muscle function and feeling to excruciating pain, the impact of nerve damage may vary.
- Infection— this is often a symptom of another injury, as the perforation of organs or internal bleeding makes it much easier for bacteria to spread and reproduce inside the body.
- Emotional suffering— women who suffer from these injuries may experience painful sexual intercourse or loss of sexual function. The inability to be intimate can have an emotional toll and the embarrassment behind these injuries can be devastating.
Transvaginal Mesh Lawsuits
Six different transvaginal mesh manufacturers and more than forty products have been named in lawsuits so far. If you have been injured following a procedure involving the use of transvaginal mesh, you may be entitled to compensation for your injuries. The Drug Law Center would like to invite you to share your story so that we can review your legal options and help you find justice.
Contact us today to arrange your free consultation with an award-winning transvaginal mesh injury attorney so that we can begin working on your behalf. We work on a contingency basis to allow anyone to have access to our top notch legal services without worrying about how they will be able to afford them. If we are unable to recover compensation on your behalf, you are assured that our services will cost you nothing. We only accept payment if we win or settle your claim.
As tens of thousands of women continue to file lawsuits against transvaginal mesh manufacturers, the companies have suffered severe legal setbacks costing them hundreds of millions of dollars. If you have been injured due to complications following a procedure using one of these devices, you may be entitled to recover compensation. The transvaginal mesh injury attorneys at the Drug Law Center have the experience and knowledge needed to ensure that you are able to collect no less than the maximum amount of damages that the law will provide so that you can see justice served.
Manufacturers Pushed Products despite Knowing About Defects
Those filing lawsuits against the manufacturers of faulty mesh products have alleged that the medical device companies were fully aware that their products were injuring women, yet continued to misrepresent the risks that women would face in order to sell more of them. Included in the charges are fraud, negligence, failure to warn and deceptive advertising practices. Plaintiffs have also alleged that mesh manufacturers actively mislead the FDA in order to keep their products on the market and did not conduct any reasonable amount of testing to make sure that their products were safe before bringing them to market.
Many of the women seeking compensation have needed to undergo revisionary surgeries to remove the mesh and continue to suffer from the conditions the mesh was meant to treat. They may also have lost the ability to function sexually, adding shame and embarrassment to the physical pain that they must endure for the rest of their lives.
Vaginal Mesh Verdicts and Settlements to Date
There have been a number of high profile claims and settlements in recent history which have given hope to the thousands of women who have not yet had their day in court. Here is a synopsis of the legal action that has led to judgements and settlements so far.
- American Medical Systems agreed to a massive settlement of over $1 billion in order to resolve thousands of lawsuits filed over its mesh products.
- Coloplast settled over 400 cases by agreeing to pay over $16 million to the plaintiffs after deciding that it could be held liable for far more if the company chose to take the cases to trial.
- A jury in Texas awarded a plaintiff with over $73 million in 2014 after she was severely injured by a Boston Scientific product. This was an indication of things to come in the future.
- Colleen Perry was awarded almost $6 million in a lawsuit filed against Johnson & Johnson and Ethicon. After her mesh product eroded, doctors attempted to remove it, but were unable to because it became embedded in her vagina. The jury determined that Johnson & Johnson “acted with malice.”
- In the most significant case to date, a jury determined that Boston Scientific was responsible for the injuries that Debora Barbara suffered after being implanted with its Pinnacle and Advantage Fit systems. The $100 million judgement included $75 million in punitive damages. The judge later reduced this judgement to $10 million in a victory for Boston Scientific. The victory has been short lived, however, as tens of thousands of women continue to seek compensation.
More than 49,000 lawsuits are still pending in courts across the nation, so this massive legal action is far from completion. If you want to know how these cases will impact your own, you should seek the advice of qualified attorney.
Let Our Proficient Transvaginal Mesh Lawyers Fight on Your Behalf
The attorneys at the Drug Law Center have helped thousands of women suffering from injuries that would have been prevented had drug and medical device companies played by the rules. If you have been injured, we would like to invite you to learn more about your legal rights and how we can help you recover the compensation you are entitled to receive. The value of your case will depend on the following.
- The cost of your medical bills, including revisionary procedures and any rehabilitation you need to undergo.
- The value of pain and suffering, which includes emotional distress.
- Loss of consortium, or the inability to share intimacy with the person you love due to your injuries.
- Loss of wages or opportunities.
Contact us today to arrange a free consultation with one of our award winning transvaginal mesh injury attorneys so that we can gather the information we need to properly review your claim. Once we have had the opportunity to conduct our review, we will let you know more about your legal options and how the legal process works so that you know what to expect and can make an informed decision about how you wish to proceed. In order to provide everyone access to our top quality services, we work solely on contingency.
This means we will never ask for any upfront fees nor at any point during your case. We will only get paid after we’ve successfully recovered compensation on your behalf and promise that our services will be completely free of charge if we are unable to do so.