Washington, D.C., Transvaginal Mesh Lawyer
Committed to Helping People Injured by Transvaginal Mesh Recover Compensation
For a variety of reasons, including having given birth multiple times, women frequently suffer from one of two conditions that result from weakened pelvic muscles. One, known as pelvic organ prolapse, or POP, causes pelvic organs to drop below their normal positions because of weakened muscles. The other condition called stress urinary incontinence, or SUI, likewise results from weakened pelvic muscles that result in the involuntary release of urine when the woman laughs, sneezes, coughs, or exercises.
Since the 1980s, millions of women have undergone surgery to correct POP or SUI, many of those involving the use of transvaginal mesh. In 2010, about 300,000 women had surgery to correct POP, while another 260,000 underwent surgical procedures to repair SUI. About one in three of those surgeries for POP used transvaginal mesh, while more than 80 percent of SUI surgeries used mesh.
What is Transvaginal Mesh?
Transvaginal mesh, often referred to as TVM, is metallic or a polymer-based screen that doctors may implant to support soft tissues where prolapse (falling out of place) occurs. While surgical mesh has been used since the 1950s—primarily in hernia repairs—in the 1970s doctors started using mesh to treat POP. By the 1990s, mesh also was used to repair SUI, leading to medical device manufacturers to develop products specifically designed to treat POP and SUI.
The FDA approved a mesh product specifically designed for SUI in 1996, and in 2002 approved a mesh product specifically designed for treatment of POP. However, as early as 2008, the federal government became aware that transvaginal mesh might create complications and began to monitor its use. By 2011, the FDA issued a formal warning that use of transvaginal mesh could lead to severe complications.
Use of TVM Can Result in Serious Complications
Over the years, many women reported serious complications arising from the use of transvaginal mesh in their surgeries to correct POP and SUI. A phenomenon known as mesh erosion—when the transvaginal mess begins to break down and flake off in pieces—began to crop up more often. These broken mesh fragments have sharp edges that can cause damage to nearby tissue and organs. Worse, it can become embedded in tissue, complicating removal, sometimes requiring several surgeries to remove all of the damaging fragments.
The FDA found that about 10 percent of women who had surgery to repair POP that involved transvaginal mesh experienced mesh erosion within a year of their surgeries. Of those, more than have required surgical removal of the eroding mesh, and many required more than on surgery. Complications from mesh erosion resulted in the death of some patients. Injuries from transvaginal mesh erosion have been found to include infections, internal bleeding, nerve damage, puncturing of nearby organs and blood vessels, difficulty urinating or pain while urinating, involuntary release of urine—a problem the mess often was intended to correct — and pain during sex.
In its 2011 report on the matter, the FDA recommended that physicians consider that POP usually can be treated without the use of mesh, avoiding mesh-related complications. The FDA also recommended that doctors opt for mesh surgery only after a careful consideration of the risks and benefits of mesh-implantation surgery versus any other surgical and non-surgical options.
Victims are Starting to Prevail in Court Actions
A large number of lawsuits against manufacturers of TVM have been filed in recent years, and manufacturers are starting to lose those lawsuits. While many outcomes remain on appeal and decisions are not final, the results in lower courts have not been encouraging for mesh manufacturers. In March 2016, with billions of dollars in legal claims filed against it, Endo International shut down its unit that manufactured TVM. In the final quarter of 2015, Endo paid $150 million in settlements in transvaginal mesh cases, and it has allocated more than $2 billion to cover potential future liabilities related to transvaginal mesh claims. In April 2017, Johnson & Johnson lost a lawsuit over transvaginal mesh damages to the tune of $20 million—a verdict that included $17.5 million in punitive damages.
Such lawsuits are unlikely to go away anytime soon. If you have had a surgery involving TVM, you should be vigilant for indications of complications.
TVM is Still Used in Treatments, but With Warnings
The FDA still allows the use of transvaginal mesh in surgeries to correct POP and SUI, although that remains under review. However, the agency has issued recommendations to women who may need surgery to correct POP. These recommendations include:
- Be aware of the risks associated with transvaginal POP repair.
- Realize that a mesh surgery could increase the need for additional surgery due to mesh-related complications, and that for a small number of patients, repeat surgery may not resolve complications.
- Be aware that there are other POP treatment options, including surgical repair with mesh, without mesh, as well as non-surgical options.
- After surgery, keep current with routine check-ups and follow-up care.
- If patients develop complications, they should notify their doctors. Symptoms could include persistent vaginal bleeding or discharge, pelvic or groin pain or pain during sex.
- Be aware of whether their POP or SUI surgery involved transvaginal mesh.
Not every POP or SUI surgery involving transvaginal mesh—or even most of them, necessarily—results in complications. However, in those cases where complications develop, they can be severe. Ignoring symptoms is ill-advised and can have serious consequences.
Call Today to Speak with a Washington, D.C., Transvaginal Mesh Attorney
If you have had surgery that required transvaginal mesh and believe you are suffering symptoms of mesh erosion or other complications from the use of mesh, you should consult an attorney to see if you can recover compensation for your injury. Attorney Michael A. Abelson at The Abelson Law Firm has helped many people through injuries caused by medical malpractice and unsafe products. Call at (202) 331-0600 or write him through our online contact form.