FDA Approves New Morcellator Device Despite Cancer Concerns

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By: Marilyn McGoldrick, Esq.

Published January 17, 2017

In 2014, the U.S. Food and Drug Administration (FDA) published a statement discouraging the use of power morcellators during procedures to remove uterine fibroids. As a result, many morcellator sellers ceased manufacturing the devices and their use has drastically declined. However, Olympus America Inc. recently launched a new bladeless morcellator that is meant to prevent the inadvertent spreading of cancerous cells. Despite these changes, the FDA required the company to include a warning on the device’s label explaining that the instrument has not been proven to reduce the risk of spreading cancer.

The Dangers of Morcellators

Morcellators are surgical devices used to break up and remove internal tissue. Basically, the instrument is made up of rotating blades that enter the abdomen through small incisions and then shred large masses of tissue for removal. These instruments allow for non-invasive procedures and so are primarily used for removing nonmalignant tumors, such as uterine fibroids or hysterectomies. Unfortunately, as doctors later discovered, when pieces of fibroids are inadvertently left behind they can migrate elsewhere in the body, which can cause serious and dangerous complications. For instance, fibroids can lead to the development of ectopic tissue implantation on abdominal organs. This, in turn, can cause obstructions, inflammation, and abnormal growths, some of which may require additional surgeries and procedures to remove.

Malignant fibroids also have the potential to spread cancer cells throughout the body when left behind in the abdominal cavity, which can be deadly for some patients. In fact, when the FDA announced the dangers of the morcellator in 2014, it stated that these devices could inadvertently spread cancer cells in as many as one out of 350 women.

Olympus America Inc. has stated that its new device will allow doctors to perform safe and minimally-invasive hysterectomies and fibroid removal. However, the evidence supporting these assertions is questionable, meaning that thousands of women may be in danger when undergoing future procedures.

How a Boston Defective Products Lawyer Can Help

Morcellators can have devastating consequences for patients and their families, so if you are a resident of Massachusetts and were recently diagnosed with cancer after undergoing a hysterectomy or standard fibroid removal procedure, please contact Thornton Law Firm, LLP by calling 888-341-1405 and a member of our dedicated legal team will help you set up an initial consultation with an experienced defective products attorney who can explain your legal options.

FBI Investigating What Manufacturers Knew About Morcellators

By Marilyn McGoldrick, Esq.

Because of concerns that federal laws may have been broken, the Federal Bureau of Investigation (FBI) is now investigating laparoscopic power morcellators, the surgical tool found to spread cancer in women. Their investigation focuses on what manufacturers knew before the FDA added a black box warning to the device in 2014. The Wall Street Journal reported that the investigation includes Johnson & Johnson (J&J) and what they knew about the morcellator’s potential to spread and upstage uterine cancers. J&J’s Ethicon Unit was the largest manufacturer of the laparoscopic power morcellator before removing the device from the market last July.

Power morcellators are used in hysterectomies and myomectomies (a procedure that removes fibroids). Inserted through a small incision, the device’s spinning blades chop the tissue to be removed into tiny pieces. But this also sprays the tissue throughout the abdominal cavity. If the patient has an undetected uterine cancer, the morcellator can spread the cancer. This spreading of the cancer is called upstaging. Now that the cancer is spread throughout the abdomen, it is more difficult to cure, and the woman’s survival rate drops drastically.

The FBI has reportedly spoken with four people in its investigation to date. Dr. Robert Lamparter, a pathologist at Evangelical Community Hospital in Lewisburg, PA, emailed J&J’s Ethicon division in February 2006, warning them about the power morcellator’s potential to spread cancer. He said that even in his small hospital, which had done 292 hysterectomies in 2005, they were finding one malignancy annually. “If a morcellation is done, the patient’s survival is jeopardized,” he wrote. J&J says it added new language to its warning after receiving Dr. Lamparter’s email, but the doctor called that new language “a legal fig leaf” in an interview with the New York Times. He also said that gynecologists at his hospital reported that their training did not substantially change after his warning to J&J.

Three other people interviewed by the FBI are well-known for their fight against the use of the power morcellator. Dr. Amy Reed, an anesthesiologist, and her husband Dr. Hooman Noorchashm, a cardiothoracic surgeon, have campaigned tirelessly against power morcellation. Dr. Reid underwent a hysterectomy for fibroid tumors in 2013. A biopsy after the surgery found a hidden sarcoma, and spread by the morcellator, her cancer was now stage 4. Both have been interviewed multiple times by the FBI. The FBI also interviewed Sarah Robinson, a physician assistant, who testified at an FDA hearing about the morcellator. She has collected a list of  386 names of women harmed by morcellation – including herself. [Update: Sadly, Dr. Amy Reed died in 2017. She was only 44 years old; survived by her husband Dr. Noorchashm and their six children.]

While  J&J’s Gynecare X-Tract, Gynecare Morcellex Tissue Morcellator, and Morcellex Sigma have been removed from the market (and those already in use recalled) other manufacturers’ morcellators are still being used. These include: Blue Endo’s MOREsolution Tissue Morcellator; the FemRx Diva Morcellator; Hologic’s MyoSure; Interlace Medical’s Hysteroscopic Morcellator; Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellators manufactured by Karl Storz; LiNA Medical’s Xcise Cordless Laparoscopic Morcellator; Lumenis Inc.’s VersaCut Morcellator; Nouvag’s Morcellator TCM3000BL; PlasmaSORD and Gyrus PKS PlasmaSORD manufactured by Olympus; Richard Wolf’s Morce-Power 2306 Electronic Morcellator; and Smith & Nephew’s Trueclear Hysteroscopic Morcellator.

If you developed a uterine cancer after undergoing hysterectomy or myomectomy with a power morcellator you may have a claim against the device manufacturer. For a free and confidential consultation about your legal rights, please call contact Thornton Law Firm’s power morcellator attorneys at 888-341-1405 or tell us your story online. Like all legal claims, claims against medical device manufacturers are subject to strict time limits. Do not delay seeking legal advice.

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