Transvaginal Mesh Lawsuit
Thousands of women throughout the United States have endured dire complications and injuries originating from Transvaginal Mesh. Our lawyers are investigating alleged claims that the defendant/the manufacturers built and sold a defective and a carelessly designed hazardous product.
We are reviewing accusations of the manufacturer failing to appropriately caution customers and the medical community about the possible risks associated with transvaginal mesh failure.
What is Transvaginal Mesh?
Transvaginal Mesh (TVM) is a net-like device (implant) that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It works by providing extra support when repairing weakened or damaged tissues.
Transvaginal Mesh Complications
In October of 2008, the FDA (food and drug administration) issued a public health notification due to thousands of injurious events reported in relation to the surgical mesh device. From January 2008 to December 2010 the FDA received an additional 2,874 complications report associated with the surgical mesh devices. Approximately 1500 of those reports were correlated in the treatment of pelvic organ prolapse (POP) and the remaining for stress urinary incontinence (SUI).
Between 2008 to 2010 the most common side effect reported to the FDA for surgical mesh devices for the treatment of pelvic organ prolapse involved:
- Pain during sexual intercourse (dyspareunia)
- Organ perforation (a break or a hole in the containing walls)
- Urinary complications
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring or shrinkage
- Transvaginal Mesh erosion
- Emotional hardships.
Due to the unprecedented claims of complications reported to the FDA, the advisory panel for the FDA recommended that the vaginal mesh for POP be reclassified from a “moderate risk” to a “high-risk” medical device in September of 2011. It is unexplained how long it can take for the vaginal mesh to erode. It can be as short as weeks or even as long as months. Nevertheless, these transvaginal mesh complications can handicap numerous daily activities, be it sitting, standing or even eating. The emotional burden can hinder a woman’s work and personal relationships.
Transvaginal Mesh Revision Surgery
Numerous patients required multiple revision surgeries, especially when needing to repair the damaged tissues and organs caused by the vaginal mesh or to remove the mesh implant. In some cases, patients required three or more surgeries to correct the injury.
Unfortunately, revision surgery is often said to be much more excruciating and complicated than the original transvaginal mesh procedure. It causes more trauma, more pain and requires a much longer recovery time.
It is not guaranteed. Some injuries may be permanent, leaving the patient to endure long term pain, nerve pain and in severe cases organ damage. Having a vaginal mesh revision surgery also poses high risks. It exposes the patients to the possibility of infection, pain and in some cases maybe even death. Between the years of 2008 to 2011 the FDA received a report of approximately 7 death in relation to transvaginal mesh revision surgery.
Moreover, the FDA has cautioned that due to the approximated 10 percent failure rate of transvaginal mesh devices, they bear a greater risk than other types of procedures. Sadly, such warnings have been disregarded by the FDA and the manufacturers of transvaginal mesh as the devices have yet to be recalled and are currently being used by approximately 75 thousand women annually.
Transvaginal Mesh Removal Surgery
Mesh is an alien body that can create a sizeable inflammation and scarring which causes the device to become scarred in very close to necessary nerves and blood vessels. Therefore, a complete removal of the mesh device is said to be rarely possible. Thus, vaginal mesh removal surgery only looks to provide symptomatic relief.
Transvaginal Mesh Lawsuit Settlements
Roughly over a 100 thousand women have filed lawsuits against the manufacturers of transvaginal mesh with the following claims:
- Failure to execute accurate and adequate testing for use of the device in the treatment of POP or SUI
- Harboring necessary information about the safety and effectiveness of transvaginal mesh
- Deluding the medical community, the public and the FDA on the possible risks and side effects of the transvaginal mesh implant
- Deficiency in establishing pertinent procedures for removal of the device.
- Millions of dollars in settlements have followed these lawsuits. Some of the known cases and settlements include:
- In a 2012 jury trial, a Bakersfield couple were awarded $5.5 million in a suit against C.R. Bard
- In a 2013 jury trial, a woman from New Jersey was awarded $3.35 million in a lawsuit against Ethicon/Johnson & Johnson
- In a 2013 jury trial, a Charleston woman was awarded $2 million in a lawsuit against C.R. Bard
- In a 2015 jury trial, Deborah Barba was awarded $25 million for pain and suffering and $10 million for punitive damages in a suit against Boston Scientific
- Colleen Perry won $5.7 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Abbrevo Sling mesh product in 2015
In some cases, the manufacturers have paid millions to settle the lawsuits. Coloplast declared to pay up to $16 million to settle the waiting 400 cases. Even the American Medical Systems paid roughly $1 billion in settlement for thousands of cases.
Transvaginal Mesh Class Action Lawsuit
Transvaginal mesh devices are made by various corporations. Therefore, class action lawsuits have been initiated against several manufacturers including Johnson & Johnson, American Medical Systems, Boston Scientific, Coloplast, and Covidien.
However, once a plaintiff embarks on a class action, the right to file a separate lawsuit is waived as class actions require a particular legal process. We recommend careful consideration and speaking with a qualified lawyer to be taken into account.
Transvaginal Mesh Lawyer
Our law firm offers free case evaluations for women who have experienced or endured complications through a transvaginal mesh device. Injured parties may be able to pursue compensation for pain and suffering, medical bills and other complications resulting from their transvaginal mesh implant.
If you or a loved one has suffered or endured a transvaginal mesh induced injury, contact our investigating lawyers now.