For women who suffer weakened pelvic muscles as they age, mesh implants are often used as a means to prevent or correct pelvic organ prolapse or stress urinary incontinence. Unfortunately, transvaginal mesh (TVM) can cause severe complications and side effects. Many affected women have filed transvaginal mesh lawsuits, also known as a TVM lawsuit, with the assistance of a defective medical device attorney.
If you or someone you love has suffered from complications as a result of pelvic mesh or TVM, contact Attorney Group for more information. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated TVM lawsuit attorney who can assist you throughout the legal process.
Have You Seen a Mesh Lawsuit Commercial?
You may have seen a transvaginal mesh lawsuit commercial on television and wondered whether you or a loved one have been affected by TVM and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What Is Transvaginal Mesh?
Transvaginal mesh treatments are administered to help women who may be suffering from conditions such as stress incontinence, pelvic prolapse, or bladder prolapse. A transvaginal mesh is a surgical mesh similar to a piece of woven fabric that is used to create an implantable mechanism for the purpose of reinforcing the vaginal wall or reversing or controlling pelvic conditions. The first transvaginal mesh device was approved by the U.S. Food and Drug Administration (FDA) in 1996.
When Is Transvaginal Mesh Used?
There are two primary health issues transvaginal mesh is used to treat. The first is when women have pelvic organ prolapse (POP). When this medical condition occurs, the pelvic organs start to become weaker and eventually slip out of their original place, or prolapse. To treat this condition with surgical mesh, this medical device is implanted into the body to provide support to the vaginal wall. When the mesh is implanted, a health care professional can either go through the abdomen or through the vagina.
The second condition surgical mesh can be used to treat is stress urinary incontinence (SUI). Women who have SUI unintentionally lose their urine when they perform certain physical functions, such as heavy lifting, coughing, running or sneezing, that put stress on their bladder. When surgical mesh is used to treat this condition, it is inserted through the vagina in order to provide greater support to the neck of the bladder in a procedure known as a mid-urethral sling.
Although surgical mesh can be non-absorbable, absorbable or a combination of the two, the FDA states that non-absorbable surgical mesh is used for urogynecologic repair. Compared with absorbable mesh, which eventually degrades over time, non-absorbable mesh is designed to provide permanent reinforcement when it is used to treat either SUI or POP. However, when non-absorbable mesh is used, it is not intended to remain at the repair site forever. Rather, as new tissue develops around the affected area, the material degrades and allows the new tissue to provide strength.
Why Are Women Filing a TVM Lawsuit?
Many people have contacted attorneys to file transvaginal mesh lawsuits because they have experienced serious complications. The complications are often caused by the artificial materials that are used to make the transvaginal mesh. Inorganic or synthetic materials have a tendency to lose shape when they are placed inside of an organic environment. The mesh materials have been shown to erode or change shape after the procedure has been completed.
The transvaginal mesh is surgically attached to the lining of the vagina, and the rough edges of the device may cut through the attached lining. This not only damages the lining of the vagina, but the materials may also cut into the rectum, uterus and bladder. Bleeding, painful intercourse, infections, and urinary problems are some of the other potential complications that can result from the transvaginal mesh. Transvaginal mesh lawsuits were nothing short of inevitable.
It is estimated that there were 75,000 transvaginal mesh operations performed in America in 2010. 10 percent of the patients who had this surgery suffered complications. The device must be surgically removed in order to correct the complications.
In many cases, tissue has grown in and around the transvaginal mesh device, which can make it very difficult for the doctor to remove the entire device. That is why some women are required to undergo multiple revision surgeries. Surgeries are not only costly, but they can also put a woman at risk for infections and pelvic damage. The pain and suffering and cost of surgery are just two of the reasons that have prompted women to file transvaginal mesh lawsuits.
Transvaginal Mesh Lawsuit Update
- June 2016 – Boston Scientific (BSC), one of seven companies facing litigation regarding the defective devices, updates the warning on its pelvic mesh products.
- February 2016 – A jury awards a TVM patient $13.5 million in a TVM lawsuit against Ethicon, Inc.
- February 2016 – Mesh maker Johnson & Johnson agrees to pay $120 million to settle 2000-3000 of the approximately 42,000 TVM cases pending against it.
- January 2016 – The FDA issues a news release stating that the agency is strengthening “requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks.”
- December 2015 – A $12.5 million verdict is handed down against a mesh manufacturer in a TVM trial.
- 2015 – A TVM lawsuit trial results in a $3.6 million verdict against a mesh manufacturer.
- 2014 – The FDA issues a news release stating that the agency is issuing “proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse.”
- 2011 – The FDA releases a Safety Communication providing an update on “Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.”
- 2008 –The FDA releases a Public Health Notification reporting on “over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices.”
Problems Associated With Transvaginal Mesh
When surgery is used to remove transvaginal mesh that was originally used to treat pelvic organ prolapse, a study discovered that although these operations could generally relieve certain adverse symptoms, they could not always relieve discomfort during sexual intercourse and pain in general. One study reviewed 90 patients who underwent an operation related to transvaginal mesh complications between January of 2008 and April of 2012. Among these patients, 48 percent experienced discomfort during sexual intercourse, 64 percent experienced pain and 62 percent experienced mesh exposure.
After the mesh was removed in these operations, 51 percent of the patients found that the procedure relieved them of all of their symptoms. However, only 51 percent of the patients who were experiencing pain due to the use of surgical mesh for POP found relief and five percent of the patients experiencing mesh exposure still experienced symptoms once the mesh was removed.
In another study, which strictly assessed the success rate of transvaginal mesh in women with stress urinary incontinence, it was discovered that one out of every 30 females who undergo SUI mesh surgery will need to either have the mesh revised or removed altogether within 10 years after the initial operation. Additionally, women who have surgeons who do less operations are 37 percent more likely to experience complications after surgical mesh is used to treat SUI. This study, which involved 59,887 women, followed patients who had SUI mesh surgery performed in Ontario, Canada, from April 2002 to December 2012.
Action Taken By The FDA
Between 2005 and 2007, the FDA received 1,503 reports relating to complications associated with surgical mesh being used for pelvic organ prolapse repairs and 1,371 reports of complications associated with surgical mesh being used for stress urinary incontinence repairs. Following these reports, in 2008, the FDA issued a warning that transvaginal mesh could cause serious complications if it was used to treat either SUI or POP.
After releasing this warning, the agency received 2,874 reports from January of 2008 to the end of 2010, that the use of transvaginal mesh was being linked to adverse health complications. Although the FDA recognized that it is common for complication reporting to increase after a warning is released from their organization, they remained concerned that the number of reports they received was so high. For this reason, the FDA decided to evaluate how safe and effective transvaginal mesh was by reviewing scientific literature published from 1996 to 2011, covering the topic of transvaginal mesh for POP and SUI repair. This review revealed the following:
- When mesh is inserted abdominally for POP repair, it is associated with lower rates of complications than when the mesh is inserted through the vagina to perform the same repair.
- Compared with traditional surgical methods used for POP repair, using transvaginal mesh to achieve the same results is associated with completely unique risks and complications.
- Using mesh for POP repair can result in anatomic benefits compared with traditional POP surgical methods. Despite these benefits, using mesh to perform the repair is not always associated with better symptomatic results for the patient.
- No evidence exists that suggests that using transvaginal mesh for POP repair, compared with traditional methods, provides any additional benefits in terms of how supported the top of the vagina and the back wall of the vagina are after surgery.
This literature review also discovered that the most commonly reported symptom associated with the use of transvaginal mesh is the mesh eroding into areas outside of the vagina. In some cases, this effect can be debilitating for women and can require multiple operations to achieve a complete repair. Additionally, this review found that complications surrounding the use of transvaginal mesh for POP repair could not be traced back to one particular brand or type of transvaginal mesh.
In 2011, the FDA issued warnings regarding the potential dangers of this device. This agency has also required the manufacturers to conduct on-going studies that examine the safety of the transvaginal mesh device. Presently, the FDA is in the process of assessing and improving both the effectiveness and safety of transvaginal mesh products. To accomplish this, the agency continues to monitor reports of adverse complications caused by transvaginal mesh used to treat SUI and POP. Additionally, the FDA is exploring various regulatory solutions that can help patients and medical providers understand the safety and effectiveness of mesh products that will be marketed in the future and those that are currently on the market.
Transvaginal Mesh Lawsuits
Currently, there are a few different manufacturers that produce transvaginal mesh devices, one of which is C.R. Bard. According to Bloomberg Business, in response to the many lawsuits that have filed due to patients claiming that their transvaginal mesh caused serious complications, Bard stated that the devices they produce are safe and effective. In June 2015, the company also stated in court that they were starting to make progress in terms of resolving the cases brought up against them.
However, after a U.S. District judge urged Bard to settle instead of potentially owing billions of dollars in damages, Bard agreed that it pay $200 million to resolve approximately 3,000 cases from women who claim they were harmed by the company’s vaginal-mesh inserts. The 2015 settlement only resolves about one-fifth of the cases that have been filed over the transvaginal mesh that they manufacture.
Although Bard decided to settle with some patients who allegedly experienced complications, other manufacturers have not. For example, in one of the largest cases involving transvaginal mesh defects so far, Reuters reports that a Delaware jury ordered Boston Scientific, a medical device manufacturer, to pay a woman $100 million in damages. In 2009, mesh products were used during an operation the woman underwent to treat both SUI and POP. Because the transvaginal mesh allegedly resulted in serious complications, the woman had to undergo two additional operations. However, the woman claimed that she was still in pain because parts of the mesh devices remained in her body. Despite these allegations, Boston Scientific denies that it failed to warn others of potential complications and that the transvaginal mesh products they produce are defective.
Women who have suffered complications from a TVM implant are encouraged to contact a transvaginal mesh lawsuit attorney to learn more about their options for filing a TVM lawsuit.
How a TVM Lawsuit Attorney Can Help
Patients who have suffered medical complications from a transvaginal mesh may be entitled to damages resulting from their injuries, including:
- Medical expenses
- Lost wages or ability to work
- Pain, suffering, and mental anguish
If a loved one dies from complications caused by a transvaginal mesh implant, family members may be eligible to pursue compensation for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Mental anguish associated with the loss of a family member
If you or a loved one received a transvaginal mesh implant and suffered complications, or if you would like to learn more about filing a TVM lawsuit, contact Attorney Group today for more information about your options.
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.
See our Frequently Asked Questions page for more information, and contact Attorney Group today.