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Transvaginal Mesh Implant

Ohio Medical Device Lawyer

A transvaginal mesh implant, also known as pelvic mesh, is a type of medical device that is used to treat two common medical conditions: Pelvic Organ Prolapse and Stress Urinary Incontinence.  These conditions may occur following child birth and pregnancy.

More than 1000 reports of mesh complications with the transvaginal mesh implant referenced in the FDA notification raised concerns about the adequacy of training, and the ability to prevent complications.  In February 2009, the FDA advised clinicians using a transvaginal mesh implant for pelvic organ prolapse and stress urinary incontinence that the clinicians should: (1) obtain specialized training, (2) be aware of adverse events associated with a transvaginal mesh implant, (3) inform patients of risks and treatment options, and (4) provide patients with the product labeling.  Since this warning, thousands of women have brought product liability actions for injuries arising from the use of transvaginal mesh.

Joe Lyon is  a highly rated Ohio medical device lawyer representing women throughout the United States who have been injured by a transvaginal mesh implant. If you have questions whether in injury was caused by a transvaginal mesh implant or the state of the national medical device litigation, please call for a free and confidential consultation.

Injuries Associated with a Transvaginal Mesh Implant

The complications and side effects possibly related to defects in the pelvic mesh. The side effects include:

  • erosion of the vaginal epithelium
  • serious infection
  • recurrence of the pelvic organ prolapse
  • urinary incontinence
  • pain during intercourse
  • severe bleeding
  • bladder perforations
  • pelvic hemorrhage
  • bowel perforation
  • blood vessel perforation
  • vaginal scaring
  • mesh erosion

How are Transvaginal Mesh Implant Complications Treated Medically?

  • Revision surgery to trim the transvaginal mesh implant
  • Revision surgery to remove the transvaginal mesh implant
  • Physical therapy
  • IV therapy
  • Surgical repair of damages organs

 

What Questions Should I ask a Physician Before Having  Transvaginal Mesh Implant Surgery?

The Lyon Firm cannot offer medical advice, but the medical literature has recommended the following:

  • patients should be informed that the use of mesh for pelvic floor repairs is considered a “novel technique”;
  • patients should be informed on the range of successes;
  • physicians should undergo specific training for these operations;
  • preoperative counseling should include a discussion of the adverse events that include—mesh exposure, pain, and dyspareunia;
  • trocarless kits are considered investigative.

What Factors Increase the Risk of Injury in Transvaginal Mesh Implant Surgery?

The guidelines further stated that the following factors may increase the adverse events:

  • lack of full thickness dissection
  • improper mesh placement
  • estrogen status
  • patient nutritional status
  • BMI
  • Age
  • smoking
  • inadequate hemostasis
  • immunosuppresion.

What Science Supports the Safety of the Transvaginal Mesh Implant?

Although the products are widely used, there is little science comparing the pelvic mesh procedures to traditional surgical methods.

Altman Study:

Altman conducted a randomized, controlled trial comparing the use of a standardized trocar guided mesh kit with the traditional anterior colporrhaphy surgery.  The trial was limited to 389 women and the composite was based on both a subjective and objective outcome.  While there was a lower rate of recurrence of pelvic organ prolapse after one year, there was a higher rate of adverse events, including bladder perforations, pelvic hemorrhage and mesh related complications. “[The] results highlight the need for careful evaluation of surgical innovations, which are often widely adopted in the absence of data from clinical trials.”


Discontinued Devices

In light of the ongoing litigation in West Virginia and New Jersey, as well as the ongoing FDA investigation, Johnson & Johnson informed both the State and Federal Courts yesterday by way of formal letter, that it intends to “discontinue or revise, as appropriate, all marketing materials” and to stop worldwide sales of the following devices:

  • Gyencare TVT Secure
  • Gynecare Prosima, Pelvic Floor Repair System
  • Gynecare Prolift, Pelvic Floor Repair System
  • Gynecare Prolift +M, Pelvic Floor Repair System

FDA Orders Future Studies

In January, the FDA ordered that J&J and 30 other makers of vaginal mesh implants implement studies to assess organ damage and other health complications alleged to be related to the products. The FDA further reported in March that The Gynecare Prolift has been sold for three years without proper regulatory approval.1

Legal Representation

Ohio GM Lawyer

If you or a loved one suffered an injury due to a faulty transvaginal mesh implant and have questions about the root cause and the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403.  You will speak directly with Mr. Lyon, and he will help you answer these critical questions

 

After two hip replacement surgeries, I was informed that one of the prosthesis was the DuPuy Joint and the other was very similar but manufactured by a different company. After several attempts to contact the manufacturer directly to discuss the claim, I was met with bureaucratic red tape that appeared to be insurmountable. I then turned to Joe Lyon of the Lyon Law Firm who immediately cut through the pro I highly recommend Joe if you are faced with the need for this type of litigation.Tim Ross
I met Joe during what was easily one of the worst times of my life. My husband had been in a serious accident and was a quadriplegic following that accident and remained in one medical facility after another until his death nearly four years later. We had contacted an area attorney who told us we absolutely did not have a case. Then we called a Cleveland firm that took the case and brought in Joe. Joe did so much of the work and became just like family to us. I would highly recommend Joe to anyone and be willing to guarantee that he will do anything and everything possible to get satisfactory results. He is extremely dedicated to his clients and very hard working. Mike and I came to think of him like a son, I still do; if it wasn’t for him I don’t believe our case would have been settled the way it was and may have ended up in a courtroom where the results can go any way.Donna Urchak