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Posted by Marilyn McGoldrick on Aug 1, 2014 3:39:00 PM

 

$5.7 Million Transvaginal Mesh Verdict Against Johnson & Johnson-media-1Update: Health insurer Highmark announced Saturday that it will stop paying for the morcellation procedure. One of the largest Blue Cross Blue Shield providers in the U.S. with 5.2 million customers in Pennsylvania, Delaware and West Virginia, Highmark is the first insurer to drop coverage of morcellation.

The Ethicon unit of Johnson & Johnson has announced that it is withdrawing its laparoscopic power morcellator, a tool used to cut tissue in hysterectomies and fibroid removals, as concerns about the device’s ability to accelerate cancer growth in women intensified. In April the Food & Drug Administration (FDA) advised doctors not to use the tool, and as a result Johnson & Johnson suspended sales of new morcellators. J&J has now sent a letter to all customers advising them to return the tool and suspend its use immediately.

The morcellator contains spinning blades and is used by surgeons in hysterectomies and myomectomies (fibroid removal) to cut up fibroids and in some cases uterine tissue. Morcellation is a less invasive procedure and offers hysterectomy patients faster recovery time. However, the act of cutting tissue may also slice into undetected sarcomas, which are often very small and look like fibroids, resulting in the sarcomatous  tissue spraying throughout the uterus and abdomen. This can result in the development of leimyosarcoma, a resistant cancer not very responsive to chemotherapy or radiation.

In the Safety Communication issued by FDA in April, the FDA said that the risk of undetected sarcoma in women undergoing hysterectomy was 1 in 350. A new study by Columbia University mirrors that, finding the risk to be 1 in 368. In the past, scientists believed that the ratio was much lower, with as few as 1 in 10,000 undetected sarcomas.

Morcellators are used in an estimated 50,000 hysterectomies per year according to the FDA, and are also used in fibroid removal alone, a procedure called myomectomy.

It is not known whether other morcellator manufacturers plan to recall or withdraw their devices. Morcellators are made by the following companies:

·         Gynecare X-Tract, Gynecare Morcellex Tissue Morcellator, and Morcellex Sigma manufactured by Johnson & Johnson’s Ethicon, Inc. unit.

·         Blue Endo’s MOREsolution Tissue Morcellator

·         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

·         Smith & Nephew’s Trueclear Hysteroscopic Morcellator

Fortunately, physicians are already developing safer alternatives to power morcellators. In Massachusetts, Brigham & Women’s Hospital has developed a procedure called enclosed or contained morcellation in which the morcellation is conducted in an enclosed environment within the abdomen. B&W also performs minilaparatomies, where a less than 4 cm incision is made and the tissue is either removed through the incision or manually morcellated to avoid spillage into other places in the abdominal cavity.

If you developed cancer after undergoing hysterectomy or myomectomy with a power morcellator and are seeking legal advice, please call Attorney Marilyn McGoldrick at 888-341-1405 or tell us your story online here. Consultations are free and held in strict confidence.