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Posts tagged "uterine cancer"

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.

FDA Approves Morcellator Bag

For decades, a device known as a morcellator was used in tens of thousands of hysterectomies and uterine fibroid removal procedures. The power morcellator ground body tissue into small fragments, allowing for its easy removal. As a result, women undergoing hysterectomies and fibroid removal procedures had faster recovery times.

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.

Power morcellator litigation is underway in Kansas

In late 2015, litigation began against various manufacturers of power morcellators in federal court in Kansas. Most of these claims are brought by individuals and surviving family members against Ethicon, Inc., a subsidiary of Johnson & Johnson. Three other companies, Karl Storz, Richard Wolf Medical Instruments Corp. and Gyrus ACMI are named in some of these claims. Each of these companies manufactured power morcellators. Each company faces allegations that they created a defective product, and failed to warn patients of the risks associated with their product.

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 Petition For Change

The power morcellator is a medical device commonly used in hysterectomies. This device cuts body tissue into tiny pieces, allowing for its easy removal from the body cavity. Most women undergo hysterectomies for uterine fibroids. For women who have a type of uterine cancer, or leiomyosarcoma (LMS), the use of a power morcellator is devastating. In fact, the use of the power morcellator in hysterectomies has needlessly caused many deaths. When cancer cells are morcellated, they will spread throughout the abdomen. Consequently, what was once a treatable stage 1 cancer can turn into a stage 4 cancer in a matter of weeks or months. The Food and Drug Administration (FDA) has been aware for years that 1 in 350 women who have surgery to remove uterine fibroids actually have LMS.

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