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We consistently hold the makers of unsafe medical devices accountable.

Every year, surgeons implant medical devices in the body of thousands of patients. Transvaginal mesh, power morcellators, hip implants, knee replacements, heart devices: they all have the potential to save—and the potential to fail. Manufacturers must be made accountable. We are a leader in medical device litigation and we have the in-depth experience and steadfast commitment to see every claim through until justice is done. Find out why Waters Kraus Paul & Siegel is the right firm for you.

Medical Device Injury

We consistently hold the makers of unsafe medical devices accountable.

The implantation of medical devices to cure common ailments and basic aging is becoming commonplace. Modern science tells us we can replace hips, rebuild knees—and even hearts—all to suit our active lifestyles.

Most of us have come to trust in the safety of these devices. After all, our doctors recommend these procedures. Surely the companies that manufacture medical devices would not sell them without sufficient testing to ensure the products’ safety.

Unfortunately, the American public’s trust is all too often undeserved. Each year, the United States Food and Drug Administration (FDA) is deluged with more than 200,000 reports of medical devices that have malfunctioned or been involved in an injury. In addition, over 2,000 device-related deaths are reported annually. Within just the last few years, recalls have more than doubled for high and moderate-risk medical devices.

In February 2022, Exactech recalled over 100,000 plastic inserts that were used in its knee replacements after discovering that the plastic can wear out early, causing the implant to fail and requiring corrective surgery. Exactech knee replacements have a three-to-seven fold failure rate when compared to other manufacturers—a startling statistic considering the FDA approved this product for safe use years ago. Many people have required revision surgery because parts of their Exactech knee replacement loosened and failed prematurely, resulting in pain, limited mobility, knee swelling, and sensitivity. READ MORE

Another commonly used medical device that has also proven to be unsafe at times is hernia mesh. Hernia mesh is a screen-like medical device used by doctors to provide additional support to a patient’s weakened or damaged muscle tissue. Recovery from hernia repair surgery varies, but typically a patient should feel relatively better than before the surgery. However, some patients suffer from complications. Some of the more severe complications include foreign body reaction, bowel perforation, and obstruction. These and other adverse events may even require revision surgery. The most serious complications can range from severely painful to life-threatening. Since 2005, the FDA has issued several hernia mesh recalls due to the number of reported adverse events. Read more

Thousands of women are treated each year for pelvic organ prolapse and stress urinary incontinence with transvaginal mesh surgery. The surgery is easier, faster and less expensive than traditional methods of surgical repair. But it also can result in horrific side effects for the patient. The mesh can degrade over time, causing infection, bleeding and excruciating pain. In some women, the transvaginal mesh actually works its way loose and cuts through the vaginal wall. In July 2011, the FDA published a Safety Communication in which it warned of the dangers associated with transvaginal mesh surgery. Many manufacturers have voluntarily pulled their mesh products from the market. Read more

How Waters Kraus Paul & Siegel can help

With a national presence and a wealth of experience representing clients injured by dangerous products and unsafe medical devices, Waters Kraus Paul & Siegel provides aggressive representation throughout the entire course of litigation. To learn more about legal representation at Waters Kraus Paul & Siegel, or to have one of our attorneys review your potential mesothelioma or other asbestos-related illness case, email us or call 800.226.9880.

Medical Device Reports: Urogynecolgical Surgical Meshes 2008-2010

  • 2,874 MDRs include malfunctions, injury, death
  • 1,503 MDRs are pelvic organ prolapse (POP) repairs
  • 1,371 MDRs are stress urinary incontinence (SUI) repairs
  • 10% of women experienced mesh erosion w/in 12 months of surgery

Source: Urogynecologic Surgical Mesh, FDA, July 2011

Medicare Patients Nationwide 2000-2007 25% increase in hip replacements 

  • 60% increase in knee replacements
  • 85% combined increase in knee and hip replacements
  • 65% largest hip replacement increase: Hawaii
  • 90% largest knee replacement increase: Delaware
  • Minnesota has the greatest number of hip implants

Source: AAOS April 2012; Dartmouth Atlas of Health Care, 2000-2007

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