Morcellator

  • Morcellator Medical Record Review & Outsourcing Services

Laparoscopic morcellation involves the use of powered surgical devices called Power Morcellators manufactured mainly by Ethicon/Johnson & Johnson. It is a 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. The Food and Drug Administration (FDA) had approved Morcellators use in 1991. This was followed by a series of power morcellators launches by Ethicon via the 510(k) process.

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:

Power Morcellators are manufactured mainly by Ethicon/Johnson & Johnson.
Product names are as follows-

  • Gynecare Morcellex
  • Gynecare X Tract
  • Morcellex Sigma
  • Diva by FemRx

Serious Alleged Injuries may 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

FDA SAFETY WARNINGS:

  • In April 2014, the FDA discouraged the use of Morcellators for uterine procedures by issuing a warning that Morcellators may spread occult cancer in the course of fibroid removal.
  • Following this, on July 30, 2014, Johnson & Johnson recalled three laparoscopic power morcellators from hospitals worldwide.
  • A second warning was announced 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 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

Lawsuit Allegations:

In October 2015, the Judicial Panel on Multidistrict Litigation transferred at least 28 Morcellator lawsuits to the U.S. District Court for the District of Kansas, under MDL No. 2652 (In Re: Ethicon, Inc., Power Morcellator Products Liability Litigation) presided by U.S. Judge Kathryn H. Vratil. The cases in the MDL included those that name Ethicon as a defendant. Lawsuits against other companies were to proceed individually in the district that they are filed.

The cases in the MDL claimed defects in the design of Ethicon, Inc.'s Power Morcellators were more likely to result in the dissemination and upstaging of occult cancer or other conditions and Ethicon failed to warn patients adequately of these risks.

According to a report published by the Wall Street Journal that $100,000 and $1 million were given as settlement by the company, to resolve approximately 100 lawsuits.

In October 2016, with most of the federal cases resolved and only a handful left, the Kansas federal judge presiding over the Ethicon Power Morcellator MDL, on June 30, remanded the remaining cases and recommended that the eight-month-old MDL be dissolved.

Evidences:

  • 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 Morcellator case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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