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Dangerous/Defective Drugs Archives

Morcellator deaths spur proposed Medical Device Guardian's Act

For decades the medical device known as a morcellator caused the death of hundreds, if not thousands, of women by spreading undetected cancer throughout their body. Despite these deaths, hospitals and physicians did not report these issues to the Food and Drug Administration (FDA). In fact, it was not until 2013, when physician Amy Reed's uterine cancer spread after a morcellation procedure, that the FDA was notified. In 2014, the FDA issued a "black box" warning on the morcellator. While this warning has severely limited the morcellator's use today, the damage was already done for many.

A proposal to protect people from unsafe medical devices

In light of the many failures on the part of the Food and Drug Administration (FDA) to adequately protect individuals from unsafe or dangerous medical devices, doctors Amy Reed and Hooman Noorchasm, have proposed a plan to strengthen regulations. Dr. Reed and Dr. Noorchasm have been personally devastated by the FDA's failure to adequately monitor medical devices, specifically the power morcellator.

When Did The FDA Know That Power Morcellators Cause Upstaged Cancer?

For nearly two decades, physicians across the United States used power morcellators in hysterectomies and to remove uterine fibroids. This device promoted faster recovery times and allowed for hysterectomies and fibroid removal to be conducted on an outpatient basis. For women with undiscovered uterine cancer, however, undergoing morcellation was often fatal.

Will The FDA Criminally Investigate The Failure To Report Morcellator Deaths?

Hospitals are required under federal law to report patient deaths suspected to have been caused by defective medical devices to the Food and Drug Administration (FDA). Medical device manufacturers are under a similar obligation. Michael Fitzpatrick, a Congressman for Pennsylvania's 8th District, asked the FDA's Office of Criminal Investigations to look into why three hospitals and one medical device manufacturer failed to report deaths caused by a power morcellator.

Despite Rising Death Toll, Doctors Ask FDA To Reconsider Morcellator Stance

In 2014, the Food and Drug Administration (FDA) warned physicians on the use of power morcellators in hysterectomies and other procedures. For years, physicians used power morcellators to grind up and remove fibroids within the uterus. While minimally invasive, morcellation can also grind up cancer cells within the uterus and spread them through the body.

A Key Step In Pursuing Justice Against Morcellator Manufacturers

Dozens of families across the United States have taken a crucial step in their pursuit of justice against the makers of a medical device that has led to upstaged cancer and for many women, death. The United States District Panel on Multidistrict Litigation (MDL) transferred all claims against Ethicon, one of the leading makers of the power morcellator to the U.S. District Court for the District of Kansas before U.S. District Judge Kathryn H. Vratil. These claims, which will be heard in Kansas City, Kansas, allege that the makers of the power morcellator failed to adequately warn users of the risks involved with their device.

A fast track to tragedy: the FDA's approval of the morcellator

A power morcellator is a surgical device that allows surgeons to cut up abdominal tissue into small pieces so that it can be removed through a small incision. It was originally designed to be used laparoscopically to minimize incision size and postop pain. Since 1995, it has been used primarily by gynecologists to remove uterine fibroids, or benign growths within the uterus. It is also used to perform hysterectomies or removal of the entire uterus. In fact, 50,000 to 125,000 hysterectomies were performed each year using a power morcellator. While this procedure was convenient and reduced recovery time, the convenience came at a fatal cost to many women.

FDA controversy brews over safety of blood pressure medications

Sometimes it takes a certain kind of pressure to inspire change. Rather than preventing harm from the start, sometimes concerned individuals are forced to respond to harm already occurring before public safety can be better ensured. Recently, a senior regulator employed at the Food and Drug Administration (FDA) was inspired by the pressures associated with potential drug side effects affecting millions of Americans to seek more stringent warnings on a top-selling class of prescription blood-pressure medications.

Pradaxa findings call the FDA's review process into question

Pharmaceutical drug and medical device approval by the Food and Drug Administration (FDA) is really the only standard by which patients can hope to secure safe treatment for their illnesses and health conditions. If the FDA approves a drug or medical device, patients and physicians alike often assume that the approved item is safe, save for any side effects or warnings listed on the packaging.

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