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Transvaginal Mesh Lawsuit

Transvaginal mesh was developed to solve one problem but ended up causing many others. If you’ve had transvaginal mesh surgery, live in New York or Long Island, and have questions about it, contact our transvaginal mesh attorneys.  New Yorkers who have been affected by transvaginal mesh complications need to know their rights.

Transvaginal mesh is used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) caused by muscles and tissues that have stretched over time, or due to childbirth or prior surgeries.  There have been severe complications due to this mesh and many patients have turned to transvaginal mesh lawyers for help.

Due to the suffering, lost work and medical bills incurred due to transvaginal mesh complications, thousands of women have filed transvaginal mesh lawsuits against medical device manufacturers.

Plaintiffs claim mesh manufacturers didn’t warn them about the chances of severe health complications, and failed to sufficiently test the mesh devices prior to putting them on the market.

The outcomes in some of these transvaginal mesh lawsuits include:

  • The jury in first federal transvaginal mesh lawsuit returned a verdict of $2 million against manufacturer C.R. Bard. The jury found the defendant didn’t adequately test its Avaulta implant, didn’t use “reasonable care” in designing the implant, and caused the plaintiff’s injuries by failing to warn her doctor about Avaulta’s risks. The verdict included $250,000 in compensatory damages and $1.75 million in punitive damages because of Bard’s “conscious indifference to [the] consequences” of its conduct.  The case went to trial in July 2013,
  • Also in 2013, a jury in New Jersey state court lawsuit returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift pelvic mesh implant.
  • In 2012, a jury in a California state court returned a $5.5 million mesh verdict, including $5 million for the plaintiff’s medical expenses, pain and suffering, and other damages, plus $500,000 for her husband’s loss of consortium claim. C.R. Bard was held responsible for paying $3.6 million of the verdict.

Each case is unique.  A transvaginal mesh lawsuit may or may not have similar results.

Why women are given mesh

Stretched pelvic muscles and tissues may have reached the point where they don’t hold up the uterus, bowel or bladder, resulting in POP or SUI. When this happens, the organs can descend and push forward into the vaginal wall.

Women with POP or SUI may have the following symptoms:

  • Painful sexual intercourse
  • Incontinence
  • Constipation
  • Pain
  • Overactive bladder
  • Pressure
  • Organs pressing into the vagina

If the symptoms are severe enough, surgery may be discussed as a treatment option.

Transvaginal mesh surgery

Traditional surgery uses sutures to “pinch together” the impacted tissues and reduce the swelling. This technique was not always successful, so in 2002 the Food and Drug Administration (FDA) approved transvaginal mesh as a treatment option for POP. Surgical mesh is now made by numerous manufacturers marketing it to treat POP and SUI.

Transvaginal mesh appears as fine netting.  Surgeons use it to create a strap that helps support organs in the pelvic area. Initially, surgeons created an incision and implanted the mesh through it.  As time passed, surgeons came up with a less invasive procedure through the vagina.  Less scarring and a shorter recovery period were the goals of the new technique, but it ended up creating multiple potential complications.

Transvaginal mesh complications include:

  • Mesh erosion through the vaginal walls
  • Pain
  • Infections
  • Bleeding
  • Painful intercourse
  • Perforation of organs
  • Urinary issues
  • Prolapse problems returning
  • Neuro-muscular issues
  • Scarring or shrinkage of the vagina
  • Emotional problems

Six years after its approval of the mesh, the FDA received over a thousand complaints concerning transvaginal mesh complications. About 2,800 more reports would come in between January 2008 and December 2010.

By July 2011, the agency took some action, warning patients and physicians of possible serious complications after mesh surgery. It also stated that using mesh to treat POP was not clearly more effective than sutures, while at the same time creating a higher risk of complications.

A study published in 2012 in the International Urogynecology Journal confirmed the FDA’s statement, finding similar initial success rates for traditional and mesh surgeries, but higher rates of transvaginal mesh complication.

Mesh removal surgery

If the complications from the mesh are severe enough, the patient has difficult decisions to make.  Revision surgery, where the mesh is removed, is an option. This may resolve the side effects or make the situation worse.

The removal surgery can be very complicated and not entirely successful for several reasons:

  • Transvaginal mesh is made of fine, but durable, material designed to last a lifetime.
  • Surgeons balance the desire to remove the mesh with a reluctance to cause undue harm in the process.  Because mesh is normally embedded into nearby tissue, that tissue may need to be cut out, resulting in injuries.  On the other hand, the surgeon will try to avoid future complications and attempt to save tissue, which may result in some mesh being left behind.

Due to the risks and complications, it’s important to be informed prior to undergoing revision surgery.

Research into revision surgery complications have found:

  • The sooner the surgery after the mesh was implanted, the more likely it would be successful.
  • Women with some nerve injuries due to the mesh received the most benefit.
  • In a study of 57 women with vaginal mesh side effects, 71 percent reported less pain or cessation of pain. However, 50 percent reported persistent pain and 25 percent reported painful intercourse.

Protect your rights.  Contact our office.

If you or a loved one in the New York and Long Island area has had transvaginal mesh surgery, you need experienced personal injury lawyers to protect your interests.

The product liability lawyers at NY law firm Edelman, Krasin, and Jaye  can help you obtain full and fair compensation for your losses. If you or a loved one is the victim of transvaginal mesh complications, contact us immediately for a free initial consultation.

  1. FDA, FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
  2. WebMD, FDA: Repairing Pelvic Organ Prolapse With Mesh Risky, http://www.webmd.com/urinary-incontinence-oab/news/20110713/fda-surgical-mesh-for-pelvic-prolapse-risky-unnecessary
  3. FDA, FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/