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How dangerous are hip replacements?

If you underwent hip replacement surgery in New Jersey prior to 2014, your artificial hip may be one of the metal-on-metal models Johnson & Johnson manufactured at that time. Should you continue to experience pain in that hip today, be aware that it could be because your metal hip is destroying your surrounding tissues

A recent New York Times article reported the horrific story of a doctor who received a Johnson & Johnson’s ASR XL metal-on-metal hip in 2006. By 2011, his hip pain was so severe that he underwent a second surgery to remove it. That was when his surgeon discovered that the artificial hip had leaked cobalt into the patient’s hip area resulting in metallosis, a condition in which the build-up of metal debris destroys a person’s muscles, ligaments and tendons. In this case, the metallosis had likewise damaged the patient’s heart and brain.

Johnson & Johnson took its ASR XL model off the market in 2010, but sold its similar Pinnacle model until 2013. More than 9,000 hip replacement patients have sued the company over their metal hips, and a jury recently awarded six New York plaintiffs $247 million in damages.

Failing medical devices

Approximately 32 million Americans have some sort of medical device in their bodies. If you are one of them, be aware that artificial hips are not the only devices that can fail, thereby causing you extreme pain and other symptoms. They can even kill you. Some of the most common devices that fail include the following:

  • Pacemakers
  • Cardiac stents
  • Heart valves
  • Vagus nerve stimulators
  • Sprint Fidelis defibrillators
  • Surgical mesh, including transvaginal mesh

Recalls abound, including the 117 Class 1 medical devices recalled in 2016 alone. Many doctors refer to the medical device industry as the “Wild West of medicine.”

Insufficient FDA oversight

While the Federal Drug Administration regulates medical devices as well as drugs, it gives much less attention to the former as opposed to the latter. For example, its 510(k) regulatory provision lets manufacturers bring a new product to market without clinically testing it if it is “substantially equivalent” to one already on the market. Another provision, called the supplemental pathway, also allows manufacturers to introduce new products without clinically testing them if the new product represents only a “minor change” to an existing product.

Such lax oversight puts you and your surgeon in the position of having to rely on a manufacturer’s claim that its medical device is safe to use. Whenever you face surgery during which your surgeon will implant a medical device in your body, be sure to fully discuss this product with him or her. Ask about known side effects and the long-term outcomes of patients who have had similar operations. In addition, do some online research about this product. If you find information that troubles you, discuss this with your doctor as well and ask if (s)he can suggest a different option.

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