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Dangers of Untested Medical Devices

The patient's right hip joint replaced by a me...

A recent Consumers Report investigation has revealed some startling news regarding medical devices.  One would expect that, because medical devices are inserted into a person's body, they are tested and retested to ensure adherence to stringent safety standards.  But the Consumer Reports revealed that this may not be the case.  In fact, the report found that many medical devices are not clinically tested at all.

According to this ABC News article, some medical devices, including defibrillators, joint replacements and surgical mesh, have not been clinically tested prior to approval by the U.S. Food and Drug Administration and use by physicians throughout the country.

In the article, Dr. Stephen Tower reveals that his artificial hip replacement because to cause him so much pain and exhaustion that he decided to have it removed.  When it was removed, they found that the "tissues around the hip had been destroyed and that metal debris was spreading down [his] thigh."  Friction in the artificial joint had caused cobalt, which is a toxic metal, to be released in his body, which eventually led to serious tissue, heart, brain and thyroid problems.

Tower's hip replacement - the ASR XL - had never been clinically tested before the FDA approved the medical device to be sold and inserted into patient's bodies.

In addition to dangerous hip replacements, "[h]undreds of thousands of women have had mesh slings inserted to support internal organs as they age, like the uterus and bladder," says Nancy Metcalf, Consumer Reports senior editor.  "Again, these products were never clinically tested before being marketed for this use."

Despite the fact that the FDA's database shows thousands of complaints about transvaginal mesh, the medical device is still on the market.

In the article, Metcalf states, "We strongly believe that the FDA should require rigorous testing for implantable devices just like they do for prescription drugs now."  Consumer Reports suggests that the creation of a national registry for medical devices is necessary in order to track implanted medical devices and alert patients of any problems with the devices. Currently there is no such tracking program for medical devices in the country, and many suspect that only a small portion of problems with medical devices actually get reported.

Last April, we reported that two U.S. Senators - Sens. Michael Bennet (D-Colo.) and Lamar Alexander (R-Tenn.), both members of the Senate Committee on Health, Education, labor and Pensions - asked the FDA to increase their oversight of medical product manufacturers following product recalls at Triad Group.  The senators had submitted a letter to the FDA in which they expressed their concern that the FDA was aware of manufacturing sterility and contamination problems at Triad Group as early as July 2009, but failed to take appropriate action to protect the public until late 2010.  In their letter, the Senators urged the FDA to review its oversight procedures with respect to medical product manufacturing to ensure that manufacturers comply with recommended safety measures.


Steinberg Goodman & Kalish  ( is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.

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