Transvaginal Mesh Lawsuit

The first transvaginal mesh entered the market in 1996 when Boston Scientific released its ProteGen bladder sling to help women suffering from stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The product was recalled in 1999 after reports of complications with the mesh.

What Is the Problem?

Boston Scientific was able to fast-track the approval process for the transvaginal mesh by submitting a Premarket Notification 510(k) to the FDA. A Premarket Notification 510(k) explains that the product is similar to an existing product that already went through FDA approval. This 510(k) process expedites the process to get the product on the market because the pharmaceutical company does not have to pay for clinical trials to test the drug or device.

Boston Scientific claimed that the ProteGen bladder sling was equivalent to hernia meshes already on the market, including Trelex Natural Mesh and Gore-Tex Soft Tissue Patch.

What Are the Injuries?

Similar to hernia mesh complications, transvaginal meshes can cause mesh migration, infection, chronic pain, and mesh erosion. Because of the 510(k) process, transvaginal meshes were not tested in a vagina before they entered the market. One of the downsides of the 510(k) process is that it allows the flaw in the equivalent products to be used in the product.

The injuries associated with a transvaginal mesh include:

  • Mesh erosion
  • Painful sexual intercourse
  • Pelvic and vaginal pain
  • Urinary leakage

Perforation of bladder, intestines or bowels

GoldenbergLaw Can Help

GoldenbergLaw is committed to promoting safety through accountability. If you or a loved one suffered from a transvaginal mesh implantation, contact us for a free case evaluation. GoldenbergLaw has over 30 years of experience in defective drug and device litigation. Call us. You will sleep better.


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The Next Bellwether Bard IVC Filter Trial Slated for September 2018

Federal Judge David Campbell of Arizona issued Case Management Order 34 on June 28 announcing that the next four Bellwether trials in the Bard IVC Filter MDL will be the Kruse, Hyde, Mulkey and Tinlin cases.

IVC filterThe Mulkey case was supposed to be the next trial but the plaintiff has been having health concerns. Therefore, Judge Campbell decided that the Kruse trial would start September 18, 2018. Hyde will begin on November 5, 2018, and Mulkey will now be held in February 2019. The Tinlin case will be the sixth bellwether trial and it will start in May 2019.

The Kruse case involves a G2 filter “non-fracture” case. The Hyde (G2x Filter), Mulkey (Eclipse Filter), and Tinlin (Recovery Filter) all involve situations where the filter fractured.

Bellwether trials are designed to provide the parties predictive insight into what would happen with certain fact situations. Because the Bard IVC filters involve generations of filters (Recovery, G2, G2x, Eclipse, etc.), different evidence has been allowed by Judge Campbell based on the different types of filters. For example, in the Booker case, the first trial ending in a $3.6 million verdict for the plaintiffs, evidence of deaths related to the Recovery filter and evidence of caudal migration was allowed. In the Jones trial, the second trial involving an Eclipse filter resulting in a defense verdict after the jury was deadlocked, the Court did not allow this evidence to be heard by the jury.

Plaintiffs have continually fought to have the Recovery death evidence and caudal migration evidence admitted in all cases since all the filters were based off of the Recovery Filter design and modified over time. This will continue to be a battle in each case.

Senior Partner Stuart Goldenberg was appointed to the Plaintiff’s Steering Committee for the Bard IVC Filters and is helping to litigate these claims for people injured by defective filters.

Have You Suffered a Perforation During Gastric Bypass or Bariatric Surgery? The GastriSail Device May Be to Blame and Was Recently Recalled.

What Is the Problem?

The GastriSail gastric positioning system is manufactured by Covidien, a division of Medtronic. The device was recalled on Feb. 20, 2018, due to “reports of gastric or esophageal perforation occurring where the GastriSail Gastric Positioning device has been used.”

This product was designed for use in gastric bypass and bariatric surgeries for the application of suction, decompression, and to expand the stomach. It also served to drain fluids, among other things.

Medtronic sent an URGENT FIELD SAFETY NOTICE in September 2017, advising that it was recalling all of these devices because there had been 18 reports of perforations.

What Are the Injuries?

A gastrointestinal perforation (GP) occurs when a hole is punctured all the way through the stomach, large bowel or small intestine. When a GP occurs, the contents of your GI tract may spill into your abdomen and cause a serious infection known as peritonitis. This can lead to sepsis and even death.

A GP can be very painful and is accompanied by nausea, vomiting, and internal bleeding and often followed by shock. A diagnosis of a GP is usually made by imaging studies that show the presence of free air in the abdomen.

Treatment usually involves fluids, antibiotics and surgery to repair the perforation. Sometimes, a bowel resection is necessary. Recovery can vary in length and intensity.

What Is the Nature of My Claim?

A product manufacturer has a duty to design and manufacture a reasonably safe product. It also needs to warn of the dangers of using the product.  Based on Medtronic’s quick recall, it is likely that the design of this product was unsafe and possibly led to your injuries. It is also likely that Medtronic failed to warn your doctor and/or the hospital of the dangers of perforation with this device. If it had done so, your doctor could have used a safer alternative.

GoldenbergLaw Can Help

For over 31 years, our experienced drug and medical device attorneys have successfully counseled thousands of injured clients through the litigation process and recovered millions of dollars in fair compensation. We believe in “safety through accountability.”  We want to help you seek justice for your injuries, and we want to prevent this from happening to others.

Please contact us for a free consultation to learn if you may have a claim. There is no fee unless we recover for you.