Issues After Transvaginal Mesh Surgery

September 23, 2011 by US Drug Recall  
Filed under Transvaginal Mesh

In 2008 and 2009, the FDA issued warnings to physicians that Transvaginal Mesh was linked to a list of complications months and even years after women had received the surgical mesh to correct pelvic organ prolapse or incontinence. These complications include infection, recurrence of prolapse, recurrence of incontinence, and organ or blood vessel perforation. Sometimes, these complications are life threatening.

The most frequently reported complication is vaginal mesh erosion. This complication is very painful because the mesh causes splitting of the skin, which increases the risk of infection. Pelvic organ prolapse can also return, which was, in many cases, what the mesh was meant to repair in the first place.

Vaginal Mesh Erosion

It was in 2009 when a clinical trial was conducted on Transvaginal Mesh that had to be abruptly stopped. Before the trial was even finished, 15% of the women had experienced vaginal mesh erosion within three months of the trial starting. As for risk factors that these women shared that led to the erosion, there were no common factors except for the fact they had received the mesh, but so had the remaining 85%. Ultimately, 15% is too high of a risk to take because most complications in clinical trials do not typically occur in more than 1% to 2% of the trial participants. If they do, the product usually does not reach the market. In this case, the mesh had already been on the market.

In 2011, the FDA issued a public notice to physicians that from January 2009 to December of 2010, 2,875 injuries had been reported in addition to those reported between 2005 and 2009. These reports involved nine manufacturers.

FDA Recommendations For Women

The FDA issued a set of recommendations for women after having Transvaginal Mesh implanted. Those recommendations say:

  • Patients should maintain their schedule of routine checkups so that complications can be caught before they come very severe
  • Patients should notify their doctor if symptoms of complications come about, such as vaginal bleeding, groin pain, pelvic pain, painful sex, or incontinence
  • Patients should always let physicians know that they have the mesh
  • Patients should address their concerns with their doctor and ask any necessary questions
  • Patients should ask if mesh was used in their prolapsed pelvic organ surgery if unsure of what the surgery entailed

If you are a recipient of Transvaginal Mesh and you are experiencing complications, you will need to contact your doctor immediately. Bleeding and dangerous infection can occur, so it is best to have any pain addressed as soon as possible.

Transvaginal Mesh Lawsuits

Because of the complications associated with Transvaginal Mesh, lawsuits have and are being filed against the manufacturers for compensation relating to the damages. The complications can cause lifelong consequences and a compromised quality of life. Women that have undergone the surgery have done so to improve their quality of life, but what is happening is the post surgery problems are worse than those before the surgery and sometimes result in several surgeries to correct. To learn of your rights and options, call to schedule your free case evaluation at 1-800-732-3070.

Transvaginal Mesh Lawsuit

September 3, 2011 by US Drug Recall  
Filed under Transvaginal Mesh

Transvaginal Mesh is used by doctors to treat vaginal walls that have been severely damaged due to stress urinary incontinence (SUI) or pelvic organ prolapse (POP). However, over time there has been an increased rate of complications after surgery in those women that have received Transvaginal Mesh.

As a result of these complications, women have sought out attorneys to file Transvaginal Mesh lawsuits on their behalf. The complications that can result do compromise quality of life because the complications can be worse than the initial symptoms of organ prolapse or the issue that led to the surgery in the first place. In both 2008 and 2009, the FDA issued warnings about these complications.

Complications

One of the most common complications that have occurred with Transvaginal Mesh is the erosion of the mesh. This can lead to excruciating pain and incontinence, as well as a number of other issues. Those issues include:

· Infections

· Severe pain

· Pelvic organ prolapse reoccurs

· Stress urinary incontinence returns

· Erosion of vaginal epithelium

Unfortunately, these complications are not rare. As of 2008, the FDA stated that these complications were rare. Since then, their stance has changed due to the facts and figures. Out of 2,874 new reports of complications between January 2008 and December 2010, 1,503 of them were related to pelvic organ prolapse repair and 1,371 of them were for stress urinary incontinence.

The result of these complications is a compromised quality of life. The surgery was done in the first place to improve quality of life. While it may have worked well for a while, it ultimately failed.

Transvaginal Mesh Design

As it stands, the design of the surgical mesh is what has been blamed for the complications that women have experienced. The same was said of the ObTape Vaginal Sling that was removed from the market in 2006. Women were reporting impaired healing, urinary tract erosion, and a variety of other complications.

It is the revelation that the ObTape blocked the surrounding tissue from getting the oxygen and nutrients that it needed that led to its removal from the market. Now it is believed that Transvaginal Mesh behaves in the same way. Some of the complications are exactly the same as what had occurred with the ObTape.

Can You File A Lawsuit?

One of the questions that women who have experienced Transvaginal Mesh side effects have asked is whether or not they can file a Transvaginal Mesh lawsuit. The answer is “yes” if you or a loved one has experienced complications related to the mesh. To find out if you can file a lawsuit, call 1-800-732-3070 or fill out the contact form on this page to schedule a free case evaluation.

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