Transvaginal Mesh Lawsuits - Consumer Justice Foundation

Transvaginal Mesh Lawsuits

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Transvaginal mesh injuries are leading to nationwide lawsuits for women injured by this medical product. If you’ve been the victim of a transvaginal mesh injury, you can talk to an attorney discreetly by filling out the form on this page.

Transvaginal Mesh Lawsuits

Transvaginal mesh is one of the most popular options for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), used in 75% of surgeries to treat POP, and in 80% of SUI repair surgeries in 2010. However, a growing body of research has suggested that the implantation of transvaginal mesh may pose a significant danger to patients, possibly putting them at risk for serious side effects, including surgical mesh infection and erosion of surgical mesh into the vaginal tissue. In fact, the FDA recently indicated that transvaginal placement of surgical mesh for POP or SUI repair may carry more risks than other surgical options, without any evidence of greater benefit. If you received a transvaginal mesh implant to correct POP or SUI, and have since suffered from one or more major side effects, contact an experienced transvaginal mesh attorney today to discuss your legal options.

Vaginal Mesh Alternatives for POP/SUI

Both pelvic organ prolapse and stress urinary incontinence are common in women who have had multiple pregnancies, had exceedingly long pushing phases of labor, or who have undergone a hysterectomy, in which the tissues and muscles in the pelvic area become weakened or damaged. Because both POP and SUI can cause severe discomfort and may significantly diminish a patient’s quality of life, many women opt for surgical repair of these conditions, which most often includes transvaginal placement of surgical mesh. Unfortunately, new information suggests that transvaginal mesh may no longer be considered a safe treatment option for some women, due to the risk of serious transvaginal mesh side effects. Some possible surgical and nonsurgical alternatives to potentially risky TVM procedures for POP or SUI repair include the following:

  • Surgery with sutures instead of mesh
  • Laparoscopic surgery
  • Surgical mesh placed abdominally
  • Weight loss
  • Adequate exercise
  • Kegel exercises
  • Avoiding caffeinated products
  • Electrical stimulation
  • Biofeedback

What is Transvaginal Mesh?

Transvaginal mesh is a type of implantable medical device used to treat conditions like pelvic organ prolapse and stress urinary incontinence in women. Originally developed in the 1950s to correct abdominal hernias, surgical mesh is made from porous absorbable biologic materials, or absorbable or non-absorbable synthetic materials, like polypropylene, polyester fibers, polytetrafluoroethylene or stainless steel. The transvaginal mesh is inserted through the vagina, and is designed to reinforce the weakened vaginal walls in women with pelvic organ prolapse or to support the urethra or bladder neck for the repair of stress urinary incontinence. In some cases, transvaginal mesh may also be used to repair vaginal vault prolapse following a hysterectomy procedure, a condition in which the vagina collapses in upon itself due to the removal of the uterus.

Possible Side Effects Leading to a Transvaginal Mesh Lawsuit

According to FDA warnings issued in recent years, implantation of transvaginal mesh devices may come with severe side effects which can seriously harm affected women. Unfortunately, warnings of major complications potentially associated with transvaginal mesh came far too late for hundreds of thousands of women who received vaginal mesh implants to repair POP or SUI. Among these potential transvaginal mesh side effects are:

  • Surgical mesh erosion
  • Surgical mesh infection
  • Urinary problems
  • Injury to nearby organs
  • Bladder, bowel and blood vessel perforation
  • Recurrence of POP and/or SUI
  • Pain during sexual intercourse
  • Revision surgery

Due to the severity of these side effects, the FDA has advised healthcare providers to consider alternative non-mesh options for POP and SUI repair, to obtain specialized training for each mesh implant technique, and to inform patients about the permanence of surgical mesh and the risk of side effects associated with the medical devices.

Link Between TVM and Side Effects

The FDA issued a safety announcement in 2008 warning the public about the serious complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. According to the FDA warning, the agency had received more than 1,000 reports over the previous three years from nine surgical mesh manufacturers of complications associated with surgical mesh devices. The most common complications included surgical mesh infection, erosion of the mesh through the vaginal epithelium, urinary problems, pain, and recurrence of prolapse and/or incontinence. Some women also suffered from bowel, bladder and blood vessel perforation during insertion, or vaginal scarring which led to discomfort and pain during sexual intercourse.

In July 2011, the FDA issued an updated safety announcement informing patients and healthcare professionals that the serious complications associated with surgical mesh for transvaginal repair are not rare. In addition, the agency indicated that it is not clear that transvaginal POP or SUI repair with mesh is more effective than traditional non-mesh repair in all patients, and may actually expose them to greater risk. While the potential side effects of transvaginal mesh are serious enough on their own, some may lead to the need for additional surgeries to remove the defective mesh, which can also be extremely dangerous. Transvaginal mesh is designed to be permanently implanted and therefore allows for tissue infiltration. Women who require surgical mesh removal may suffer from additional complications resulting from surgery, including hemorrhage, permanent disfigurement, and scarring of the pelvic tissue and muscles.

Lawsuits Against Surgical Mesh for Infection, Erosion and Other Injuries

1999 – Boston Scientific recalls its ProtoGen mesh product, just three years after it was approved, due to safety concerns.
June 2012 – Johnson & Johnson’s Ethicon subsidiary stops selling four of its Gynecare mesh devices (Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secur, and Gynecare Prosima Pelvic Floor Repair System Kit), after more than 600 women file claims against the mesh manufacturing company.
July 2012 – A California jury returns a $5.5 million verdict for a woman who claims she was injured by side effects from a transvaginal mesh device manufactured by C.R. Bard, including $5 million for the plaintiff’s medical expenses and pain and suffering.
July 2012 – C.R. Bard stops selling its Avaulta Plus mesh device, amid concerns about its safety and effectiveness.
2013 – A verdict of $11 million is returned from a New Jersey jury, in a lawsuit filed by a woman who allegedly suffered injuries from Ethicon’s Gynecare Prolift vaginal mesh device.
2013 – A woman who alleged serious injuries caused by a transvaginal mesh device manufactured by Johnson & Johnson is awarded $1.2 million in damages.
June 2013 – American Medical Systems agrees to settle a number of TVM claims filed in state and federal courts across the country for $54.5 million.
July 2013 – In the first federal trial involving a transvaginal mesh device manufactured by C.R. Bard, the jury returns a verdict of $2 million against the medical device maker.
September 2013 – A transvaginal mesh case is settled a few days before the trial was scheduled to begin in New Jersey.
2014 – Transvaginal mesh maker Coloplast agrees to pay $16 million to resolve about 400 lawsuits filed over the company’s mesh devices.
May 2014 – American Medical Systems reaches an agreement to settle about 20,000 transvaginal mesh claims for up to $830 million.
September 2014 – A federal jury in West Virginia awards $3.27 million in damages to a woman who claims that her Ethicon Gynecare transvaginal mesh device caused her to suffer permanent injuries.
September 2014 – A jury in Texas awards $73 million to a plaintiff who alleged that Boston Scientific was “grossly negligent” in manufacturing and selling its vaginal mesh devices.
November 2014 – Boston Scientific loses two federal trials back-to-back, including one in West Virginia involving an $18.5 million award, and another in Miami involving a $26.7 million award.
December 2014 – The federal judge overseeing the vaginal mesh litigation asks mesh maker C.R. Bard to settle more of its cases, warning that the company could otherwise face billions in jury verdicts.
January 2015 – C.R. Bard appeals a $2 million jury award brought against the company in July 2013, but the judge overseeing the case upholds the verdict.

FDA, TVM and Side Effects

October 2008 – A Public Health Safety Notification from the FDA suggests that complications from vaginal mesh used for the repair of POP are rare.

July 2011 – The FDA issues an update on serious side effects associated with transvaginal mesh, indicating that has received 4,000 reports of adverse events associated with transvaginal mesh in the previous six years. The agency also updates it previous statement, warning that TVM complications are, in fact, not rare.

September 2011 – An advisory committee for the FDA meets to discuss the safety and effectiveness of transvaginal mesh products.

January 2012 – Based on recommendations from its advisory panel, the FDA orders the makers of transvaginal mesh products to conduct post-market studies on the safety of surgical mesh devices.

February 2012 – The FDA issues 95 post-market study orders to 34 manufacturers of vaginal mesh devices for POP repair, and 14 orders to seven manufacturers of vaginal mesh devices for SUI repair.

April 2012 – Federal regulators report that women who have had transvaginal mesh implanted to support their reproductive organs may be at a greater risk of bleeding, pain and infection than women who have undergone traditional surgery with stitches.

March 2013 – The FDA makes changes to its web page to include updated information about adverse events possibly associated with transvaginal mesh for POP and SUI repair.

May 2014 – The FDA submits two proposed orders to reclassify vaginal mesh as a Class III device, which means the products would require stringent premarket testing prior to widespread distribution.

Transvaginal Mesh Side Effect Studies

August 2008 – Retracted mesh resulting in vaginal pain occurred in 11.7% of patients who underwent transvaginal mesh procedures, according to a large retrospective multicenter cohort study published in the Journal of Obstetrics and Gynaecology Research.

February 2009 – The rate of revision surgery to correct complications, as well as the total reoperation rate, is highest for vaginal mesh kits compared to native tissue and abdominal repairs, according to research published in the medical journal Obstetrics and Gynecology.

May 2009 – The Journal of Minimally Invasive Gynecology publishes a study finding that transvaginal mesh erosion rates range from 7% to 20%.

July 2009 – A study published in the American Journal of Obstetrics and Gynecology finds that 18% of women who underwent transvaginal mesh procedures developed pelvic muscle dysfunction and pain, with one-quarter of these women experiencing continued symptoms after six months of therapy.

April 2010 – A report published in the Cochrane Database of Systematic Reviews evaluates 3,773 participants in 40 trials of different surgical procedures for pelvic organ prolapse, and shows that there is a higher rate of side effects from vaginal mesh compared to native tissue repairs, including a 10% rate of mesh erosion complications.

April 2010 – Research published in Ultrasound in Obstetrics & Gynecology indicates that 9.3% of patients experienced severe mesh contraction or shrinkage, defined as a decrease of more than 50% of the size of the vaginal mesh, at three months after the mesh device was implanted.

May 2011 – A five-year follow-up in a cohort of 85 women following transvaginal mesh surgery, published in the journal Female Pelvic Medicine & Reconstructive Surgery, finds the overall rate of vaginal mesh exposure to be 18.8%, with 56% of patients requiring surgery for partial mesh excision.

February 2013 – A study conducted by researchers from the University of North Carolina (UNC), and published in the International Urogynecology Journal suggests that using transvaginal mesh versus native tissue for POP repair is tied to a five-year increased risk of revision surgery.

March 2013 – A study conducted by researchers from the Mayo Clinic, and published in Current Bladder Dysfunction Reports, indicates that traditional native tissue repair is the best procedure for most women undergoing vaginal pelvic organ prolapse repair, compared to vaginal mesh-augmented repair of POP.

Why We Think TVM Makers Should Be Held Liable for Vaginal Mesh Side Effects

More and more women across the country are coming forward with horror stories about painful and debilitating transvaginal mesh complications, and to date, tens of thousands of lawsuits have been brought against the makers of vaginal mesh devices, like Bard Avaulta mesh, over life-altering side effects. All of the transvaginal mesh lawsuits involve similar allegations that the makers of surgical mesh products:

  • Designed, manufactured and sold defective and unreasonably dangerous devices
  • Failed to adequately research the long-term effects of transvaginal mesh
  • Concealed the risk of complications from women undergoing transvaginal mesh repair of POP or SUI
  • Failed to provide adequate warnings to consumers and the medical community about the alleged risk of transvaginal mesh side effects
  • Promoted their mesh as safe and effective devices, despite these risks
  • Claimed that complications from transvaginal mesh devices were rare, even though adverse event reports showed thousands of women were suffering from vaginal mesh side effects like mesh erosion and infection

What should you do? If you have suffered mesh infection, erosion or another serious side effect, you should contact a lawyer as soon as possible to discuss filing a transvaginal mesh lawsuit.

The side effects potentially linked to transvaginal mesh are severe and may cause permanent injuries that require long-term medical care. If you or a loved one has suffered from a transvaginal mesh side effect, legal help is available. Contact an experienced surgical mesh attorney to discuss the benefits of filing a surgical mesh lawsuit against the manufacturing company responsible for producing the medical device. The main goal of surgical mesh lawsuits is to help injured victims seek financial compensation for their injuries, the medical cost of treating their injuries, and the pain and suffering endured by victims and their families. By hiring an experienced transvaginal mesh lawyer to represent your case, you can protect your legal rights and seek fair and timely reimbursement for your losses.

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