FDA Considers Safety of Metal Medical Devices

Metal Knee and Hip Replacement PartsFor more than 100 years, metal has been used in some medical devices. Recently, however, the Food and Drug Administration (FDA) announced its plan to evaluate the safety of metal in medical devices. Based on patient reports and adverse event reports, the agency is concerned that some metals from some medical devices could cause serious injury in some patients.

While metal has been used in medical devices for years, the science that explains why some people may have immune reactions to the metal is continually developing. Now, the FDA is making understanding the science behind metal medical device safety a priority. Specifically, the agency is calling on scientists, patients, healthcare providers, and other interested parties to identify:

  • What science is available to evaluate metal medical device safety
  • What further science could be helpful to evaluate metal medical device safety
  • What the FDA could do to understand this critical safety issue better

Metals Used in Medical Devices

Some of the specific metals used in metal devices include:

  • Stainless steel
  • Cobalt-chrome alloy
  • Titanium
  • Nitinol

Gold, silver, platinum, iridium, tantalum, and tungsten are also used in medical devices.

Each type of metal could create health risks in some patients.

Risks of Metal Medical Devices

The FDA cited two specific concerns when it informed the public that it would be reviewing the safety of metal in medical devices. Specifically, the FDA is concerned about:

  • Inflammatory reactions. The FDA is considering whether some people may be predisposed to immune or inflammatory reactions to certain metals. These reactions may be localized to the part of the body where the metal medical device is implanted or more systemic. Fatigue, joint and muscle pain, rash, and weakness may all be signs of an inflammatory reaction.
  • Tissue death near the implant site. The tissue around the medical device implant may die. Tissue death can result in significant pain and interfere with your quality of life.

Over the years, these serious health problems have occurred after patients were treated with a wide variety of metal medical devices.

Metal Medical Device Lawsuits

Over the past few years, people hurt by metal medical devices have filed lawsuits because of injuries suffered by:

  • Essure. Essure is a set of metal coils inserted into a woman’s fallopian tubes during a doctor’s office visit. Within a few months of insertion, scar tissue forms around the metal coils to permanently block the fallopian tubes and prevent pregnancy. Some women suffered severe side effects from Essure, however, including infection and allergic reactions. Essure is no longer available in the United States, but women who already have the implant remain at risk of injury and may pursue lawsuits if they are hurt.
  • Knee and hip replacements. Premature failure rates, tissue damage, and other injuries are some of the problems associated with knee and hip replacements. Some of the specific knee replacements that have caused injuries include the DePuy Synthesis Attune Knee Replacement Implants and the Zimmer Persona Knee System and High Flex Knee Implant. Defective metal hip replacements that have caused injuries include Stryker's LFIT Anatomic CoCr V40 Femoral Heads, Stryker’s Rejuvenate and ABG II Hip, and DePuy’s Pinnacle Hip Replacements.

Some plaintiffs have made significant financial recoveries for their past and future medical costs, lost income, out-of-pocket expenses, physical pain, emotional suffering, and other damages.

Protect Your Rights If a Metal Medical Device Causes Your Injury

Don’t wait for the FDA to act on this critical issue. You can protect your recovery by contacting a medical device injury lawyer today for a free, no-obligation consultation. We will thoroughly review your claim and give you an honest opinion about your legal options. Then, you can decide what steps you want to take next. If you choose to file a medical device injury lawsuit, then we will help you every step of the way.

Fill out our online contact form or call us directly at any time to learn more about protecting your rights after a metal medical device injury.

 

John L. Keefe
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Founding Attorney, Massachusetts Social Security Disability Lawyer