Advice

Hernia Mesh Implants Lawsuits (Vaginal Mesh Complications & Claims)

When it was introduced in the 1990s, vaginal mesh was heralded as a safe and permanent fix for female pelvic organ prolapse (POP), a condition that happens when a woman’s pelvic muscles weaken causing the pelvic organs – including the bladder, vagina, rectum and uterus – to drop into the vagina. It’s a condition that typically plagues older women, women who have undergone childbirth, a hysterectomy and menopause.

Vaginal Mesh Complications

Vaginal mesh, made from a flexible plastic material, is surgically implanted through the vagina. After incisions are made in the vagina and supporting tissue near the vagina, this hammock-like device is stitched under the prolapsed organs. The mesh is supposed to support the organs and reinforce the weakened vaginal tissue.

In some cases, however, the mesh is known to erode, causing pain and infection. The U.S. Food and Drug Administration (FDA) says that 10 percent of women experience mesh erosion within one year of the surgery. Typically, erosion symptoms happen within a month of the initial surgery, with pain during sex, vaginal scarring, vaginal shrinkage and organ perforation being the most common.

Some women have opted to have the mesh surgically removed. The procedure is difficult but can be successful in removing irritating mesh.

Vaginal Mesh – FDA Warnings

Today, all the vaginal mesh devices on the market are modeled after one device Boston Scientific’s ProteGen, which was pulled from the market amid safety concerns in the 1990s. In July 2011, the FDA issued a safety communication about all vaginal mesh devices, warning health-care providers and patients about the dangers.

While the FDA decided not to pull the device from the market, it did call for more stringent testing of new mesh products. The FDA has also required 35 mesh manufacturers to perform three-year studies on the products.

Vaginal Mesh Claims

Women from around the country have already filed court complaints against the multitude of companies that make vaginal mesh, as well as similar bladder sling devices. The many differing manufacturers each carry a variety of types of slings and mesh products:

  • American Medical Systems (AMS) – MiniArc Precise Single-Incision Sling System, MiniArc Single-Incision Sling System, BioArc SP Sling System, BioArc To Subfacial Hammock, In-Fast Ultra Transvaginal Sling, Monarc Subfascial Hammock, SPARC Sling System, Acticon Neosphincter; Elevate Prolapse Repair; Perigee; Straight-In Sacral Colpopexy; Apogee
  • Bard Medical – Avaulta Plus, Avaulta Solo, Pelvisoft Biomesh, Pelvitex Mesh, Pelvilace Biourethral Support System, Pelvicol Acellular Collagen Matrix, Uretex, Uretex To Trans-Obturator
  • Boston Scientific – Advantage Fit System, Capio CL, Obtryx Transboturator, Precision Twist, Solyx SIS, Advantage Transvaginal Mid-Urethral, Lynx, Precision, Prefyx PPS, Capio, Pinnacle, Repliform, Folyform, Xenform
  • Ethicon (a division of Johnson and Johnson) – Gynecare Prolift, Gynecare TVT, Gynecare Gynemesh
  • Mentor Corp. – Obtape
  • Tyco: IVS Tunneler

Transvaginal Mesh Lawsuits

MESH VICTORY: $5.5 Million Awarded to Transvaginal Mesh Victim

July 23, 2012: A jury has awarded $5.5 million to Christine Scott, a 53-year-old woman implanted with a transvaginal mesh patch, and her husband. Scott suffered painful complications that required extensive revision surgeries.

The case is the first settled of more than 1,300 lawsuits filed against manufacturer Avaulta Mesh, C.R. Bard Medical for adverse effects caused by their products.

Transvaginal Mesh Removed from Market

Ethicon, Inc., a subsidiary of Johnson & Johnson and the manufacturer of several transvaginal mesh implants, announced it is pulling four of its products from the market. They are:

  • Gynecare TVT Secur system
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System

This represents a great victory for the thousands of women who have filed or plan to file transvaginal mesh lawsuits. 

These were the first four mesh patches to be removed from the market. Although Ethicon terminated sales of these products, the company insisted it was not a recall. However, given the strain of hundreds of lawsuits and criticism by the FDA, the companies clearly felt enough pressure to stop sales.

J & J and Ethicon will continue to sell their one remaining transvaginal mesh product, Gynemesh PS, with a new warning label.

More Than 6,500 Transvaginal Patch Lawsuits Currently Filed Against Manufacturers

In total, more than 6,000 federal and 500 state lawsuits have already been filed by women who were injured by defective transvaginal mesh patches. Federal mesh cases have been consolidated into four multidistrict litigations (MDL) based on the manufacturer they’re filed against. Transvaginal mesh MDL pretrial proceedings are in full swing, and a trial date has been set by Chief Judge Joseph R. Goodwin. As of October 2012, the number of suits filed in MDLs against each manufacturer continues to increase rapidly:

  • 1,898 cases filed against AMS
  • 1,867 cases filed against Johnson & Johnson’s Ethicon division
  • 1,186 cases filed against Boston Scientific
  • 1,323 cases filed against C. R. Bard
  • 40 cases filed against Coloplast

Bards Avaulta Transvaginal Patch

C.R. Bard Inc. manufactures a family of transvaginal mesh implants. The company’s products include:

  • Avaulta Solo Synthetic: polypropylene mesh support without additional products
  • Avaulta Plus Biosynthetic: polypropylene mesh with a matrix of cross-linked collagen on one side of the mesh
  • Avaulta Biosynthetic: polypropylene mesh with hydrophilic collagen coating (available in a kit for anterior or posterior implantation)

Plaintiffs in lawsuits filed against C.R. Bard claim the company was negligent in the products design and failed to warn patients about the risk of complications.

Johnson & Johnson Transvaginal Mesh Patch

The Johnson & Johnson (J&J) transvaginal mesh patch may cause serious and non-reversible injuries. Until June 4, 2012, Ethicon, a subsidiary of Johnson & Johnson, manufactured surgical mesh products, including:

  • Gynecare TVT Secur system
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System

American Medical Systems

Lawsuits filed against American Medical Systems (AMS) claim flaws in the design, manufacturing, testing, marketing and/or labeling of the AMS transvaginal mesh products caused women who received them to suffer serious and irreversible damages. Defective patches made by AMS include:

  • AMS Apogee
  • AMS Bioarc
  • AMS Elvate
  • In-Fast Ultra
  • MiniArc
  • Monarc
  • AMS Perigee
  • SPARC
  • Straight-In

Boston Scientific

Boston Scientific has also been named in lawsuits filed by women who have suffered serious and life-altering complications after being implanted with the company’s transvaginal mesh products, which include:

  • Advantage Transvaginal Mid-Urethral Sling System
  • Lynx Suprapubic Mid-Urethral Sling System
  • Obtryx Transobturator Mid-Urethral Sling System
  • Pinnacle Pelvic Floor Repair Kit
  • Precision SpeedTac Transvaginal Anchor System
  • Precision Twist Transvaginal Anchor System
  • Prefyx System
  • Solyx SIS System
  • Uphold Vaginal Support System

Vaginal Mesh Compensation

With the large number of court cases mounting, a multidistrict litigation (MDL) has been established involving several makes and manufacturers of the mesh. The MDL proceedings create consistency among the different lawsuits.

Women who have had mesh implanted and are suffering from it should seek financial compensation for their time off work, medical expenses, pain and overall changes in lifestyle. Even with medical insurance, the cost of removing damaging mesh can be financially straining.

Hernia repair surgeries are one of the commonly performed in the U.S. To be precise, over a million people undergo the procedure in a year. In hernia repair surgeries, a medical device known as a surgical mesh is used to add support to weakened or damaged tissue. Patients who have undergone the procedure and as a result are experiencing complications have the right to file for a hernia mesh lawsuit.

Hernia Mesh Failure

The mesh implant has been in use for hernia repair surgeries since the early 1950s. Moreover, hernia mesh-based surgeries increased a lot since the 1800s and by the year 2000, only 10% of the surgeries performed on the hernia did not include using a mesh. However, the surgery has never been risk-free. Failure in hernia mesh repair surgeries can cause some serious side effects and complications such as recurrence.

According to a study in a medical journal (Surgical Endoscopy), 42 percent of patients who undergo hernia mesh-based repair surgeries experience complications. A further 18 percent in the same group experienced some kind of mechanical failure of the mesh. Less than 10 percent of the patients suffered adhesions, severe pain and their bodies rejected the mesh.

A different study found that around 20 to 30 percent of mesh-based repair surgeries failed thereby causing esophageal damage.  Patients who underwent such complications needed additional surgery and had to live with undying impairment in their digestive system.

The symptoms related to failure in surgery of mesh-base hernia repair are; internal bleeding, infection, issue erosion in the repaired part, pain and recurrence of hernia on the affected area. These side effects can be life threatening and treatments require using antibiotics. A warning was issued by the USFDA concerning the damages and side effects of undergoing mesh-based hernia repair surgeries.

Hernia Mesh Lawsuits

You are not guaranteed to get fixed after a failed hernia repair surgery. If the mesh used was defective and caused complications in your body, you might be entitled to some settlement.

Leave a Comment

Your email address will not be published. Required fields are marked *