Transvaginal Mesh Lawyer
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Transvaginal mesh is a medical device used to treat some conditions that can affect women.
Modern mesh devices are made from polypropylene, a type of plastic, that is woven into mesh and coated in material to reduce the risk of infection.
Transvaginal mesh placement has become a popular procedure for many women in recent years for a variety of conditions usually after women have given birth or undergone a hysterectomy. Most frequently, transvaginal mesh is placed via the vagina in order to prevent incontinence or to treat pelvic organ prolapse. Although transvaginal mesh has become a common treatment for these conditions, there have also been several troubling side effects associated with the placement of transvaginal mesh according to a warning issued by the United States Food and Drug Administration in 2011. The FDA’s warning was issued after they received more than 1,000 reports of complications over the course of only three years and references “erosion through vaginal epithelium, infection, pain, urinary problems, and bowel, bladder, and blood vessel perforation during insertion.” According to the FDA’s warning, there is also a risk of the prolapse recurring or of the patient developing or redeveloping incontinence complications.
Many lawsuits have been filed against the makers of transvaginal mesh seeking compensation for injuries caused by the device. Our transvaginal mesh lawyers are currently investigating and gathering information about these cases.
What is Transvaginal Mesh Used For?
Transvaginal mesh, or sometimes just referred to as vaginal mesh, is mainly used to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). These conditions most often occur in woman after childbirth, menopause, or a hysterectomy.
Stress Urinary Incontinence (SUI)
Urinary incontinence is the inability to hold urine in the body. Stress Urinary Incontinence is the inability to hold urine when physical stress is exhausted, such as lifting something heavy, or sneezing. Childbirth is one of the main cause of SUI, which explains why the condition is much more common in women. Although, men who undergo prostate surgery are also at risk for this condition, as removing the prostate can weaken the urethral sphincter. Synthetic vaginal mesh can be installed surgically to support the urethra.
Pelvic Organ Prolapse (POP)
Pelvic Organ Prolapse is the lowering of pelvic organs in the body. This condition occurs when the muscles supporting these organs weaken, causing the organs to drop lower and push against the walls of the vagina. There are several organs that make up the pelvic organs, although the bladder is the most common of these organs to experience prolapse. Organs that can prolapse include:
Like SUI, POP is often a result of childbirth. Straining during delivery of a child can weaken and stretch muscles supporting these organs. Additional pressure on the belly area can cause POP to become worse. Factors such as being overweight, chronic cough, constipation, and tumors in the pelvic region can worsen this complication.
Pelvic organ prolapse can be painful, but if often not a serious medical concern. Doctors install transvaginal mesh in patients with POP to support the organs in the area and prevent them from prolapsing again.
The FDA has classified surgical mesh into four different categories. See the chart below:
|Synthetic, Non-Absorable||Polypropylene||Permanent implant that remains in the body until it is removed.|
|Synthetic, Absorbale||Polypropylene||Not permanent. Will lose shape and strength over time, as the body grows new tissue over the mesh.|
|Biologic||Bovine (cow), Porcine (pig)||Mesh implant made from disinfected animal tissue. As mesh degrades, body will regrow tissue over repair area.|
|Composite||Combination||Mesh implant made from conbining biologic and synthetic materials.|
Transvaginal Mesh Complications & Problems
Although transvaginal mesh implants have helped improve the quality of life in many women, there have been serious complications and adverse side effects associated with these devices. These complications have been so dangerous to some patients, that legal action has been taken against the manufacturers of vaginal mesh implants.
Transvaginal mesh instead has been found to cause considerable pain, discomfort, and other health complications for recipients of the implant. The mesh has been found to move out of place and break off into pieces. Complications of this include pain, nerve damage, infection, bleeding, internal scarring, organ perforation or damage, painful intercourse, and pelvic organ prolapse. While it is possible to undo the damage, it is a challenging process. The mesh was designed to be permanent so the body quickly grows around it. It requires multiple revision surgeries to remove each individual mesh piece from the body.
Lawsuits have been filed and settled, and more lawsuits are expected to be filed in the coming months. Below you can learn about serious side effects of transvaginal mesh implants, all of which should be discussed with your attorney.
Erosion occurs when the mesh gradually wears away the vaginal wall. When this occurs, women often experience pain during intercourse. Sometimes, this can prevent the patient from having intercourse at all because the pain is so severe. General pain can also occur on a regular basis. In some cases, uncontrolled internal bleeding can result from damage done by the device.
The complications caused by vaginal mesh erosion can lead to revision surgery procedures. Additionally, when transvaginal mesh migrates and erodes, it often may cause the original issue (SUI or POP) to return.
Organ perforation is often an extreme result caused by mesh that has moved from its intended location and punctured an organ in the pelvic region. Not only is this a medical emergency, but damage to structures inside the pelvic area can also lead to infection is not treated quickly. Patients who suffer from damaged organs due to vaginal mesh will often require surgery.
Stress Urinary Incontinence (SUI) is a condition that occurs primarily in woman and is marked by involuntary leakage of urine caused by physical activity. SUI occurs more in women due to the length of the urethra, which averages 8 inches shorter than the male urethra. Pregnancy and childbirth can also contribute to SUI complications.
The bladder sling’s function is to create a “hammock-like” structure around the bladder neck and urethra. This supports both organs and keeps them sealed during activities that previously would trigger incontinence. Patients who receive bladder slings cannot lift heavy objects for 1-3 months after the procedure. Additionally, to minimize the risk of infection, patients are asked to refrain from sexual intercourse and using the bathtub for a period of time.
FDA Communication on Transvaginal Mesh Products
In October 2008, the FDA released it’s first safety communication regarding potential dangers associated with transvaginal mesh. This initial bulletin reported that between 2005 and 2008, the FDA had received over 1,000 reports of complications associated with several different types of vaginal mesh. The majority of the adverse effects reported were erosion complications, while a smaller portion of the reports dealt with organ perforation during and after installation.
Three years later, the FDA released an updated safety communication that stated “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” Additionally, the update went on to state that there was no indication that transvaginal mesh is more effective than traditional non-mesh alternatives.
As lawsuits continue to be filed and settled, the FDA continues to investigate transvaginal mesh and the potential danger they pose to consumers.
The U.S. Food and Drug Administration have not yet issued a recall for transvaginal mesh implants despite the fact that these devices have been linked to dangerous side effects. In January 2012, they did issue post-market surveillance study orders. After these orders were issued, many device manufacturers withdrew their products from the market.
Although transvaginal mesh implants have not yet been recalled, you can still pursue a lawsuit with the help of a lawyer if you or someone you care about has been harmed by the device.
Transvaginal Mesh Lawsuits and Settlements
Tens of thousands of transvaginal mesh lawsuits have already been filed since the FDA first warned about possible complications in 2008. Over 40 thousand lawsuits alone have been filed in the U.S. District Court for the Southern District of West Virginia. These lawsuits were consolidated in six separate multi-district litigations, which are all being presided over by Chief Judge Joseph R. Goodwin.
Multiple pharmaceutical manufacturers have been named in these lawsuits, they include:
|Boston Scientific||Cook Medical|
|Ethicon (Johnson & Johnson)||American Medical Systems|
Bladder Sling Multi-District Litigation
It is estimated that about 35,000 women received ObTape bladder slings in the three years the device was on the market. However, only a small fraction of these women have come forward claiming complications with the device. The lawsuits filed by these patients has been consolidated into a single multi-district litigation (MDL) in the U.S. District Court for the Middle District of Georgia. The judge presiding over the MDL, the Honorable Clay D. Land, is allowing the pre-trial proceedings of similar cases to also be consolidated. Nearly 400 cases are still pending in federal court.
Millions of dollars have already been paid out to victims who have been injured by transvaginal mesh with the help of their attorneys. Many of the major mesh manufacturers have reached settlements, and yet still more cases are pending in federal court. Below are some of the notable verdicts and settlements reached in United States transvaginal mesh cases.
|Individual||Bakersfield, CA||C.R. Bard||$5.5M (2012)|
|Individual||Atlantic City, NJ||Ethicon||$3.35M (2013)|
|Individual||Charleston, WV||C.R. Bard||$2M (2013)|
|Multi-District||Charleston, WV||Endo||$54.5M (2013)|
|Multi-District||Charleston, WV||Endo||$830M (2014)|
|Multi-District||Charleston, WV||Coloplast||$16M (2014)|
American Medical Systems Inc., a subsidiary of Endo International PLC, settled 20,000 lawsuits in 2014 for nearly $830 million. The lawsuits alleged that the company’s vaginal mesh implants had eroded and left the plaintiffs in severe pain.
Coloplast, a Danish medical device manufacturer, settled 400 transvaginal mesh lawsuits for $16 million in March 2014. The settlement will pay out an average payment of $40,000 to each claimant.
In March 2015, California resident Colleen Perry was awarded $5.7 million in her pelvic mesh injury trial. The jury awarded her $100,000 for medical expenses, $100,000 for noneconomic damages, $500,000 for future noneconomic damages, and $5 million in punitive damages.
The lawsuit alleged that the mesh device Perry had received hardened and eroded tissue inside her vagina, making intercourse with her husband extremely painful. The defendant argued the risks were well known and Perry had signed an informed consent form prior to receiving the implant.
Debora Barba v. Boston Scientific Corporation
A Delaware jury awarded Debora Barba $25 million in compensatory damages and $75 million in punitive damages after they found Boston Scientific to be negligent in designing their transvaginal mesh devices, which had caused severe bladder infections and abdominal pain in Barba. The $100 million verdict was reduced to $10 million by a Delware judge in October 2015.
Martha Salazar v. Boston Scientific Corporation
Another lawsuit against Boston Scientific resulted in a large jury verdict for Texas resident Martha Salazar in 2014. The jury returned a verdict of $73.5 million dollars to be awarded to the plaintiff due to the injuries caused by Boston Scientific’s Obtryx bladder sling ($23 million compensatory damages, $50 million punitive damages). The 42-year-old Salazar was unable walk or sit normally due to the device, which also caused serious internal injuries. The bladder sling was originally installed to treat minor incontinence.
File a Transvaginal Mesh Lawsuit with the Help of an Attorney
If you or a loved one has been injured after receiving a transvaginal mesh implant, you may be entitled to file a lawsuit and recover compensation with the help of a transvaginal mesh lawyer. Contact our attorneys today to get started on your case.