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Laparoscopic morcellation involves the use of powered surgical devices - Power Morcellators manufactured mainly by Ethicon/Johnson & Johnson. It is minimally invasive technique which is increasingly used by surgeons these days to take out bulky specimens from the abdomen. This procedure pulls large masses of tissue into a spinning blade, which then cuts the tissue at a high velocity into smaller pieces to be more easily removed through laparoscopic incision sites. FDA had approved Morcellators use in 1991.
Power Morcellators were first used for uterine extraction and have since become heavily implemented during laparoscopic gynecological procedures, particularly in minimally invasive myomectomies and robotic, supracervical hysterectomy. Surgeons also use power Morcellators in nephrectomies and splenectomies, surgical procedures to remove the kidney or spleen in both men and women.
Product information/Proof of usage:
Product names are as follows-
- Gynecare Morcellex
- Gynecare X Tract
- Morcellex Sigma
- Diva by FemRx
Major complications of Power Morcellators include
- Spread and upstage of undetected malignant uterine tissue
- New leiomyomas, including parasitic fibroids endangering a woman's fertility and reproductive health
- Spread of cancerous cells to other areas of the body (Metastatic Adenocarcinoma, Peritoneal Sarcomatosis, Peritoneal Ieiomyosarcoma, ovarian, and renal)
- Contamination of healthy organs in the abdominal cavity showing signs of inflammation, infection, and pain and bowel obstruction
- Growth of abnormal masses on other organs, requiring additional surgery to remove
- Death can be resulted from release of spleen or kidney fragments into the abdominal cavity
Since April 2014 the Food and Drug Administration (FDA) has discouraged Morcellators' use for uterine procedures, issuing a warning that Morcellators may spread occult cancer in the course of fibroid removal. A second warning was followed on November 25, 2014, where the FDA issued an "Immediately in Effect Guidance Document" recommending that manufacturers of these surgical tools add a black box warning to the product's packaging. The black box warning is the FDA's strongest warning.
The agency estimated that approximately 1 in 350 such patients is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma and recommended laparoscopic power morcellators not be used in the following cases:
- In women with suspected cancer
- In peri or postmenopausal women
- Women who are candidates for procedures where tissue is removed intact, without cutting, through the vagina or a mini-laparotomy incision
The sale of its Morcellators is suspended by Johnson & Johnson, and they will wait till the role of Morcellator is redefined by FDA. The cases in MDL involve common factual questions arising from allegations that (1) defects in the design of Ethicon, Inc.'s power morcellators made laparoscopic hysterectomy or myomectomy procedures more likely to result in the dissemination and upstaging of occult cancer or other conditions, and (2) Ethicon, Inc. failed to warn patients adequately of these risks given the FDA's recent communication discouraging the use of power morcellation for treatment of uterine fibroids and revising the risk that uterine fibroids were actually sarcoma.
28 Morcellator lawsuits were transferred to the U.S. District Court for the District of Kansas, by Judicial Panel on Multidistrict Litigation. Johnson & Johnson's subsidiary Ethicon has settled nearly 70 lawsuits till March 30, 2016 in which women claimed to be injured by uterine cancer after been operated for hysterectomy using Morcellators. It was a report published by Wall Street Journal that an amount of $100,000 and $1 million was given as settlement by the company, which may resolve approximately 100 lawsuits.
Evidence to be looked for in potential cases
- Usage of Morcellators during gynecological laparoscopic procedures in medical records
- Indications for Surgery and use of Morcellator
- Equipment log during the operation
- Operative reports for initial surgery
- Biopsy reports of uterine specimen during gynecological procedures
- Follow up complications and their treatment after initial surgery
Medical Record Review and claim validation of Morcellators case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.