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Defective or Recalled Medical Devices and Implant Litigation

Consumers complain that medical devices, while designed to help, can cause additional irreversible injuries. As with defective drugs, defects in medical devices can occur from inadequate testing and rushing the approval process to get a product on the market.

The likely risk of injury caused by a defective medical device is greater than its possible benefits. A defective medical device is either flawed in design, manufacture, inadequate instructions or insufficient warnings, and it does not achieve its intended purpose. Another defect may be in warnings to physicians and to consumers. The prescribing physician must be warned of any dangerous potential risks associated with a medical device.

Defective medical devices can include shoulder pain pumps, hip and knee replacements (Zimmer Durom Cup), dialysis machines, defibrillators, heart valves, stents, and more.

According to a past article in the Washington Post:

  • Nearly 2,500 medical devices were recalled for potential safety problems in 2008
  • The FDA only requires comprehensive tracking of 14 types of devices (including pacemakers, mechanical heart valves, and breast implants)
  • Over 100 “Class I” recall notices went out from January to July 2009 regarding defects that are serious enough to cause a reasonable probability of adverse health consequences or death
  • Over 1,000 recall notices went out from January to July 2009

Transvaginal Mesh

Have you or a loved one been implanted with a transvaginal mesh? The product was marketed by numerous companies, reportedly linked to an increased risk of erosion, infection, pain and urinary problems.

Have you suffered from any of the following?

  • Severe pelvic, abdominal or groin pain
  • Recurrence of pelvic organ prolapse or incontinence
  • Autoimmune problems
  • Nerve damage, neuromuscular problems
Protrusions into or punctured lower abdominal organs
  • Surgery (or multiple surgeries) to repair damages caused by the implant
Many other possible complications

Even if you’ve had no complications
 with your transvaginal mesh, you may be entitled to compensation.

For many years, women have been told there was a simple solution to problems such as stress urinary incontinence and pelvic organ prolapse. The solution was a simple, hammock-like piece of plastic mesh that would be surgically implanted through the vagina to provide support to the pelvic organs. But the complications that would become part of the women’s lives after the surgery would be life altering! These injuries can interfere with many everyday activities, including walking, sitting, and sexual intercourse. Many require multiple surgeries to repair the damage. The emotional harm, on top of the physical damage, can affect a woman’s relationships, work, and daily activities. Sometimes surgeries cannot even correct the damage.

Problems with vaginal mesh systems marketed by a number of different medical device manufacturers have caused women throughout the United States to suffer these severe injuries.

Not only do these products pose a risk of serious complications, there is no evidence that transvaginal insertion of a bladder sling has any benefit for women when its primary use is treating pelvic organ prolapse.

We can evaluate and investigate your potential claim if you have received any type of surgical mesh or bladder sling to repair pelvic organ prolapse.

These are some of the major brands of mesh that have been recalled:

  • Bard Avaulta Support System
  • AMS Elevate Prolapse Repair System
  • AMS Apogee Vault Suspension System
  • AMS Perigee System
  • AMS Monarc Sling System
  • AMS Sparc Sling System
  • Ethicon Gynecare Gynemesh
  • Ethicon Gynecare Prolene Soft Mesh
  • Ethicon Gynecare Prolift Pelvic Floor Repair System
  • Ethicon Gynecare TVT Transvaginal Sling
  • Boston Scientific Pinnacle Pelvic Floor Repair Kit
  • Boston Scientific Uphold Vaginal Support System
  • UGYTEX Dual Knit Mesh
  • Coviden IVS Tunneler Sling

Due to the risk of vaginal mesh complications, the FDA warned in July 2011 that doctors should recognize that in most cases, pelvic organ prolapse can be treated successfully without a bladder sling or pelvic mesh. Thousands of women had a bladder sling or vaginal mesh implanted in recent years, and compensation may be available for serious injuries caused by the defective and dangerous design of the pelvic support systems. Call us today to discuss if we can assist you on a potential claim or lawsuit regarding a defective medical device.

Have you or a loved one had a defective or recalled medical device implanted in your body? Transvaginal Mesh questions? Call for a FREE legal consultation now!

Gregg S. Harrison, Attorney at Law, PLLC
Greater Houston/Northwest Houston Defective or Recalled Medical Device/Implant Lawyer
Office: 281-929-0110
Cell: 832-797-7600