Hawaii Transvaginal Mesh Lawsuits

Our transvaginal mesh lawyers at The Dunken Law Firm are accepting and investigating cases on behalf of women in Hawaii and throughout America who have suffered severe complications. Victims from every city in Hawaii have the option to discuss their claim with us for free, including:

  • Honolulu
  • Pearl City
  • Hilo
  • Waipahu
  • Kailua Cdp

If you or a loved one has sustained transvaginal mesh injuries, our team of extensively experienced lawyers will advocate you while pursuing the compensation that you are warranted. Contact our firm today to set up a free initial consultation.

Why Choose Us

  • We have a thorough knowledge and understanding on litigating defective medical device cases, as we have over 25 years of experience.
  • We approach every case with compassion and a commitment to respecting and understanding our clients’ best interests.
  • We are service-oriented and devote ourselves to providing clients with attentive and responsive legal counsel.
  • We will put in the time and effort, no matter how long it takes, to obtain successful results for you and your family.

Transvaginal Mesh FDA Warning Ignored

Transvaginal mesh was approved at an accelerated rate in 1996 for use in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Since similar products had market approval already, transvaginal mesh went through the U.S. Food and Drug Administration’s 501(k) approval process, meaning the device was not required to undergo clinical trials.

Unfortunately, over time the FDA has received thousands of reports showing that the implantation of transvaginal mesh to correct these pelvic floor disorders are further injuring most women, rather than repairing their ailments.

The FDA has yet to issue any product recalls, but serious health safety communications were issued in 2008 and in 2011 warning about transvaginal mesh, after thousands of women came forward with alarming injuries.

Manufacturers are still producing transvaginal mesh, despite health warnings. Lawsuits against the manufacturers have successfully resulted in the voluntary recall of at least some of the dangerous surgical devices.

The following manufacturers sell transvaginal mesh under different product names, including:

  • C.R. Bard: Avaulta Plus™ and Avaulta Solo™ Vaginal Mesh Implant, Faslata® Allograft, Pelvicol®, PelviSoft®, Pevlitex™
  • Boston Scientific Corp.: Advantage™ Sling System, Obyryx®, Prefyx Mid U™, Prefyx PPS™
  • American Medical Systems (AMS): SPARC® Sling System, Apogee Vault Suspension System, Elevate Prolapse Repair System, Monarc Sling System, Perigee System
  • Ethicon (Johnson & Johnson): Gynecare TVT, Gynemesh PS, Ethicon TVT, Prolene Mesh Patches, Secur

In a continuing effort to research and weigh the benefits of transvaginal mesh versus the risks, the FDA has reclassified the device as high-risk (class III), when used for pelvic organ prolapse. The reclassification requires manufacturers to test the safety and efficacy of each transvaginal mesh device before filing a premarket approval application.

Serious Transvaginal Mesh Complications and When They Appear

Transvaginal mesh implanted for POP has the highest risk of complications, but when used to fix SUI, success rates are higher and the risk of side effect is lower.

After a procedure to repair POP, patients will experience typical postoperative symptoms such as bleeding and pain, that should dissipate within six weeks.

Pain that persists months after the surgery, possibly during activities or during sexual intercourse, may be an indication of a more serious complication. Other symptoms indicative of a serious mesh side effect can be frequent urinary tract infections, new incontinence, or blood found in urine.

One of the most common complications reported is mesh erosion. Shortly after implantation, the device can begin to break down and erode surrounding tissue or cause vaginal shrinkage. Nerve damage, pain, and scarring can be the result. The erosion may cause pieces of the device to break off and perforate nearby organs or tissue, causing bleeding, pain, and possibly infection.

Call The Dunken Law Firm Today

You deserve highly qualified legal representation that will advocate for you during this difficult time, so that you may focus on healing. Contact us and schedule a free consultation to find out how our transvaginal mesh lawyers can help you.