By Ashley Milano  |  October 2, 2014

Category: Legal News

Ethicon vaginal meshEthicon (a subsidiary of Johnson and Johnson) fraudulently concealed the dangers of transvaginal mesh and is in violation of consumer protection laws, according to a recent vaginal mesh lawsuit.

The vaginal mesh lawsuit filed by Patricia Mattox alleges that the Gynemesh and TVT implanted surgically in 2004 to treat her medical condition were negligently designed, thereby causing serious side effects including mesh erosion, organ damage, chronic pain and other vaginal mesh complications.

The vaginal mesh lawsuit accuses Ethicon of negligently manufacturing and selling defective and unreasonably dangerous products, and withholding information from consumers and the medical community about the risk that transvaginal mesh may erode through the vagina, cause infections and other injuries.

About Transvaginal Mesh

Transvaginal Mesh (or Gynemesh) and Transvaginal Tension Free Vaginal Tape (TVT) are medical devices that are surgically implanted to treat Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI).

SUI typically occurs in women after childbirth and/or pregnancy due to muscle weakness in the pelvic area, causing urine to leak from the body during activities such as coughing, laughing, and exercising. POP typically occurs in older women whose muscle and tissue groups in the uterus, bladder and pelvic region have become stretched and weakened. Women also have an increased risk of developing POP with menopause and hysterectomy.

Transvaginal mesh surgery is supposed to strengthen the internal organs and prevent them from coming into contact with each other by implanting mesh tape.

Johnson & Johnson’s Ethicon Women’s Health & Urology division is responsible for manufacturing many transvaginal mesh devices. This division of Johnson & Johnson offers treatments for a variety of female pelvic and reproductive organ health conditions. Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:

  • Ethicon TVT
  • Gynecare TVT
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch
  • Secur

Transvaginal Mesh Complications

In January 2012, the U.S. Food and Drug Administration (FDA) ordered the makers of transvaginal surgical mesh products to study the risks associated with the products. The order came following the recommendation of an FDA advisory panel in September 2011. According to the FDA, between 2008 and 2010 the number of adverse events reports to the FDA about transvaginal mesh increased fivefold. Not all surgical mesh products are affected by the FDA’s order. Those that are implanted through the abdomen are not included.

Transvaginal mesh implant complications include the following:

  • Mesh erosion into the vagina, bladder, intestines and uterus
  • Infection
  • Pelvic pain or neuropathic pain
  • Urinary problems, including incontinence
  • Development of urinary retention
  • Bowel, bladder, and blood vessel perforation during insertion
  • Vaginal scarring
  • Dyspareunia (pain with sexual relations)
  • Fistulas and recurrence of prolapsed organs

Johnson and Johnson’s Ethicon division continues to make these transvaginal mesh devices, despite warnings by the FDA and medical experts. There are more than 1,000 known cases of women who have been seriously harmed by these medical devices.

Transvaginal Mesh Lawsuits

As of January 2014, more than 40,000 transvaginal mesh lawsuits have been filed against manufacturers including C.R. Bard, Ethicon, American Medical Systems (AMS), and Boston Scientific. While some claims have been settled, approximately 3,000 TVM lawsuits a month are being filed. Many of these vaginal mesh lawsuits have been filed in multidistrict litigation in federal court in Charleston, W. Va.

Mattox is seeking restitution and punitive damages for Ethicon and Johnson & Johnson’s alleged gross negligence and failure to warn.

The Ethicon Vaginal Mesh Implant MDL is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation MDL no. 2327 in the U.S. District Court for the Southern District of West Virginia.

In general, vaginal mesh lawsuits are filed individually by each plaintiff and are not class actions.

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