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What is Transvaginal Mesh?

Transvaginal mesh is used for women who suffer from Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). These are characterized by the dropping of the bladder, uterus, bowel and/or rectum of a woman, resulting in the organ pushing against the wall of the woman’s vagina. This usually occurs in women who have had vaginal births or have undergone surgeries that cause their pelvic muscles to lose strength.

Mesh products were produced in order to relieve pain as well as to alleviate bowel and bladder issues associated with POP and SUI.

It’s important to note that there are a number of vaginal products that have been promoted and sold to hospitals, medical staff, and facilities, with some of these items potentially causing serious personal injury.

The list includes:

  • Tyco IVS Tunneller
  • Gynecare Prolift
  • Prolift MTM
  • Tvt Secure
  • Prosima
  • Caldera T-Sling
  • Caldera Desara Pelvis Mesh
  • Coloplast
  • Avulta
  • Bard Pelvisoft
  • Bard Pelvilace

Transvaginal Mesh Linked to Complications

Transvaginal Mesh Side Effects

  • Transvaginal Mesh Erosion
  • Organ Perforation
  • Infection
  • Pain During Intercourse
  • Internal bleeding

Who is Liable?

Here are the transvaginal mesh manufacturers responsible for designing a defective medical device and failing to warn patients and doctors of the dangerous side effects.

  • Ethicon (Johnson & Johnson)
  • Boston Scientific
  • CR Bard (BD)
  • American Medical
  • Coloplast
  • Cook Medical

Transvaginal Mesh Lawsuit

Women who have been harmed by transvaginal mesh complications will be looking to file lawsuits against the company that made the product. Plaintiffs will want to receive the following:

  • Compensation for pain and suffering
  • Reimbursements for past and future medical bills
  • Lost wages if surgical mesh complications caused missed work
  • Loss of consortium
  • Punitive damages against the manufacturer if there was an element of misconduct

As of January 2018, there have been approximately 73,000 product liability claims filed against those who have manufactured or sold transvaginal mesh products. The number of pelvic mesh lawsuits continues to grow as more transvaginal mesh recipients experience complications and injury.

The statute of limitations begins from the time a recipient of the device knew or should have known that they were injured. It does not begin with the date that the mesh was implanted. As a result, those who have received the mesh, even many years ago, can still file suit so long as the injury did not occur until the applicable period of limitation. Given that this device is a figurative, “ticking time bomb” implanted in a woman’s body, it is likely that injuries will continue to occur and the number of transvaginal mesh lawsuits will continue to increase in the future.

Your law firm still has the opportunity to help victims of these defective mesh implants hold the responsible manufacturers responsible and bring awareness to this nationwide dilemma. The statute of limitations for these cases allows women to file a claim years after they have had their surgery. Broughton Partners has the resources and expertise to find the transvaginal mesh lawsuit leads your law firm wants.

1996

The FDA approved the first transvaginal mesh implant, ProteGen, manufactured by Boston Scientific. The device was approved with the 501(k) process which allowed minimal testing for three months on rats and no human trials.

1998

The FDA investigated a Boston Scientific site and found that the mesh implant had dangerous risks that were not reported by the company. Despite their findings, the FDA determined that a recall was not needed.

1998

Johnson & Johnson’s mesh implant, Gynecare, was approved by the FDA with the 501(k) process.

1999

Boston Scientific voluntarily recalled the ProteGen after hundreds of women filed complaints of adverse events.

2003

Boston Scientific settled hundreds of transvaginal mesh lawsuits for an undisclosed amount.

2008

The FDA issued a public health notification to warn patients about the potentially severe complications that vaginal mesh implants may cause. The notification stated that there were over 1,000 adverse event reports related to the device.

2011

The FDA issued a safety communication stating that the use of vaginal mesh implants may put women at a higher risk of injuries.

2013

A woman was  awarded $3.35 million in a transvaginal mesh lawsuit against Johnson & Johnson.

2013

C.R. Bard was ordered to pay a woman $2 million in a product liability lawsuit claiming the manufacturer developed a defective medical device and failed to adequately warn doctors of its risks.

2016

The FDA placed transvaginal mesh implants into class III and now requires manufacturers to submit a premarket approval application, a strict device review pathway.

April 2019

The FDA ordered all manufacturers of transvaginal mesh for pelvic organ prolapse to immediately halt all sales and distribution of products.

October 2019

Johnson & Johnson agreed to pay a settlement of $117 million to resolve a lawsuit that claimed the company deceptively marketed its transvaginal mesh device and failed to warn patients and doctors of its severe risks.

References

FDA. “Urogynecologic Surgical Mesh Implants: Reporting Problems to the FDA”, U.S. Department of Health and Human Services. Accessed April 19, 2019.

Mayo Clinic. “Get the facts about transvaginal mesh complications”, Mayo Foundation for Medical Education and Research. Accessed April 22, 2019.

Hemendra N. Shah, Gopal H. Badlani. “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review”, US National Library of Medicine National Institutes of Health. Accessed April 22, 2019.

Matthew Goldstein. “As Pelvic Mesh Settlements Near $8 Billion, Women Question Lawyers’ Fees”, The New York Times. Accessed April 22, 2019.

Department of Surgery, Division of Urology. “The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics”, Female Pelvic Medicine & Reconstructive Surgery. Accessed April 22, 2019.

Toyohiko Watanabe, MD, PhD and Michael B Chancellor, MD. “Pelvic Surgeons Caught in the Meshes of the Law”, US National Library of Medicine National Institutes of Health. Accessed April 22, 2019.

Priscilla DeGregory. “Johnson & Johnson settles for $117M in vaginal mesh lawsuit“, New York Post. Accessed October 25, 2019.

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