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Posts tagged "FDA"

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.

Johnson & Johnson continues to settle morcellator claims

For decades, Johnson & Johnson manufactured power morcellators for use in hysterectomies and uterine fibroid removal procedures. While use of the morcellator promoted faster healing times, for women with undiagnosed uterine cancer, morcellation was usually fatal. This was because morcellators grind body tissue into small fragments, which are then removed from the body. Tragically, the morcellator would also grind up cancerous tissue, and tiny pieces of the cancerous tissue would spread across the abdominal cavity, taking a treatable Stage 1 cancer and turning it into Stage 4 cancer in a short period of time.

U.S. Congressman asks Vice President Biden to reform medical device review

The Obama Administration has created an initiative with the hopes of reducing and even eliminating cancer. Vice President Joe Biden is leading this initiative, known as the National Cancer Moonshot. One of the National Cancer Moonshot's goals is to develop an Oncology Center within the Food and Drug Administration (FDA) to identify and develop new cancer treatments.

Despite the loss of human lives, the New England Journal of Medicine comes out in favor of morcellators

For decades, surgeons used power morcellators in hysterectomies and in myomectomies, a procedure to remove uterine fibroids. Unfortunately, for women with undiagnosed uterine cancer, power morcellation causes cancer to spread throughout the abdominal cavity. This can take a relatively treatable Stage 1 cancer and transform it into Stage 4 cancer within weeks.

The FDA Plans To Inform the Public on "Emerging Signals" For Medical Devices

While A Welcome Development, This Is Too Late For Victims of Morcellation

In a memorandum titled "Public Notification of Emerging Postmarket Medical Device Signals" the Food and Drug Administration (FDA) announced that it intends to take a more proactive approach to warning the public about potentially dangerous medical devices. Currently, the FDA relies on reports of patient deaths, complications and other adverse outcomes before deciding whether to warn the public about drugs and devices.

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.

Getting Answers From The FDA About Power Morcellators: The U.S. House Gets Involved.

On November 17, 2015, the House Committee on Energy and Commerce held a hearing entitled "Examining the Regulation of Diagnostic Tests and Laboratory Operations." In this hearing, various members of Congress questioned Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health (CDRH), which is part of the Food and Drug Administration (FDA).

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.

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