Surgical Mesh Manufacturers Under Scrutiny Now
Juries have returned several judgments against pelvic mesh manufacturers throughout the last decade. After pursuing their claims in court, plaintiffs have earned millions of dollars in compensation for medical costs, chronic pain, injuries, and mental distress. Thousands of legal lawsuits against transvaginal top mesh manufacturers like Ethicon, Coloplast, and Boston Scientific have been resolved for almost $8 billion.
In 2012 and 2013, the first transvaginal mesh cases were heard in court. Several vaginal mesh manufacturers have lost multimillion-dollar lawsuits since then. Many corporations have agreed to substantial legal settlements to avoid facing litigants in court, while others have postponed procedures and settlements.
Multiple juries have agreed with plaintiffs who accused firms of falsely marketing device safety, developing faulty medical devices, and neglecting to warn of possible risks. Despite several settlements, thousands more claims remain outstanding in federal and state courts. It is still being determined if the manufacturers will attempt to settle or fight outstanding claims.
Surgical Mesh Implants are…
Surgical mesh is a medical device or material that offers extra support while healing frail or damaged tissue. Most surgical mesh devices today are constructed of man-made (synthetic) materials or animal tissue.
Surgical mesh, or Hernia mesh, is a medical device that helps mend damaged tissue through laparoscopic surgical procedures. Surgeons connect the mesh to the region around the hernia using sutures, staples, or adhesives. The mesh pores enable new tissue growth inside the device. In the United States, hernia mesh is used in nine out of every ten hernia repair surgeries.
What is the most common mesh used for?
Mesh has been utilized in urogynecological treatments such as pelvic organ prolapse (POP) repair, hernia repair surgery, and stress urinary incontinence (SUI). Mesh is implanted for long-term reinforcement of the weak vaginal walls for pelvic organ prolapse repair or to support the urethra or bladder neck for urinary incontinence surgery. To treat pelvic floor diseases using surgical mesh, three primary surgical techniques are performed:
- · POP may be treated using transvaginal mesh.
- · Transabdominal mesh for POP treatment
- · SUI treatment using a mesh sling
Each surgical procedure has the risk of serious complications and advantages. Currently, no FDA-approved surgical mesh solutions for transvaginal prolapse repair are on the market in the United States.
Top Surgical Mesh Manufacturers: Ethicon, Boston Scientific, Coloplast
Surgical repair mesh products are part of a $48 billion business supporting sales of other medical devices. Hernia mesh producers provide almost 70 different mesh brands. A few businesses dominate the market in the United States for hernia mesh products.
Manufacturers of polyester mesh vary from large, well-established corporations to small start-ups.
Ethicon is a division of the healthcare behemoth Johnson & Johnson. It is a multinational company that sells its goods all over the globe. Its products include surgical instruments, suture repair products, and mesh. Some of the company’s hernia and pelvic mesh devices have resulted in damage lawsuits, million-dollar settlements, and judgments.
Several of Ethicon’s products in its mesh portfolio are the subject of litigation. Transvaginal mesh, surgical staplers, and hernia mesh are examples of these.
- · Gynecare TVT Secur
- · Gynecare Prolift Kit
- · Gynecare Prosima Pelvic Floor Repair System
- · Gynecare Prolift + M Kit
Boston Scientific is a Massachusetts-based corporation that makes medical devices. They have a track record of creating ground-breaking medical products. In recent years, this has included improvements to its common products and the development of gadgets that can replace medications used in current medical treatments.
Other cutting-edge Boston Scientific products, like transvaginal meshes, have also been the subject of recalls and hundreds of product liability lawsuits in recent years, costing billions of dollars in lost income.
- · ProtoGen Sling
- · Advantage
- · Pinnacle Pelvic Floor Repair Kit
- · Obtryx Slings
- · Uphold Vaginal Support System
Coloplast, which is based in Humlebaek, Denmark, provides healthcare products such as wound care, ostomy care, therapeutic skin care, and urological care. It has its headquarters in Minneapolis, Minnesota, and employs over 10,000 people worldwide.
The firm has had some issues in the United States, including putting aside hundreds of millions of dollars to resolve transvaginal mesh claims filed by women who claimed they were damaged by the company’s devices used in pelvic surgery for stress urinary incontinence and pelvic organ prolapse.
- · Novasilk Sling
- · Minitape
- · Aris Transobturator Sling
- · Omnisure
FDA Orders Surgical Mesh Ban intended for transvaginal repair
The ProteGen Sling was the first mesh device approved by the FDA for SUI in 1996. About three years later, Boston Scientific issued a recall on the product.
However, the FDA approved several variations on the ProteGen Sling design before it was taken off the market.
Over the last decade, the FDA has issued safety notifications, held advisory committee meetings, and even forced manufacturers to cease sales of surgical mesh for certain transvaginal procedures after reclassifying the devices as “high-risk.”
As a result of adverse effects such as mesh erosion, organ perforation, and infection, more than 100,000 women have filed claims against the manufacturers of transvaginal mesh.
Other mesh producers have also pulled the plug, although none of their mesh devices have ever been recalled.
Effective March 26, 2019, transvaginal mesh cannot be used to treat pelvic organ prolapse. The FDA reiterated the dangers associated with the transvaginal implantation of surgical mesh for treating POP in October 2022.
Surgical Mesh Lawsuits Happening Now
People who brought cases had hernia mesh complications that required at least one additional hernia surgery. Some people needed more. Furthermore, many patients allege that their difficulties persisted following revision surgery.
As the third and fourth bellwether trials, presently slated for October 2023 and January 2024, approach, Bard demands that a federal court replace those two trials with new plaintiffs. The business, which makes multiple polypropylene mesh devices that are the subject of litigation, contends that the plaintiffs’ situations in those instances have deteriorated to the point that they are no longer typical of the hundreds of other outstanding complaints.
More than 18,000 cases are underway against Bard, which have been merged into a multi-district litigation (MDL) in the Southern District of Ohio. Bellwether cases, also known as test trials, predict how jurors react to testimony and facts provided in surgical mesh trials. The results of the bellwether trials may have an impact on the settlement amounts for the remaining claims. The next scheduled case management meeting for this complaint will take place before District Judge Edmund A. Sargus on June 13, 2023.
Contact us to get more information on how you can file your own lawsuit related to transvaginal mesh.