Power Morcellator Case Evaluation Criteria

Power morcellators are sharp tube-shaped blades that are most often used for laparoscopic or robotic hysterectomies and fibroid removal surgeries. It is used in minimally invasive procedures to grind uterine tissue and fibroids into fragments so that the material may be removed from the body via a small incision in the abdomen. Since the late 1990s, the use of power morcellators in hysterectomies and fibroid removals has become increasingly popular, with about 55,000-75,000 procedures performed in the U.S. every year.

Morcellators have been promoted as a way to reduce pain, speed up recovery, and leave less scarring. While this is true in comparison to open abdominal surgery, the benefits are less clear when compared to other minimally-invasive laparoscopic techniques.

FDA warning:

The FDA released a safety warning about these tools and their dangers in April 2014 after the U.S. regulatory agency discouraged the use of these products. According to the alert, power morcellation poses a risk of spreading undetected cancerous cells, notably uterine sarcomas, beyond the uterus. The alert noted that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma, and that the spread of this cancerous tissue into the abdomen and pelvis can significantly reduce a patient’s chances of long-term survival.

Johnson & Johnson (J&J) is suspending worldwide sales of its laparoscopic power morcellators (Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator,) after a warning by the US Food and Drug Administration (FDA).

Lawsuit focus:

List of Morcellators and Manufacturers

  • FemRx – Diva Morcellator
  • Hologic – MyoSure
  • Lumenis Inc. – VersaCut Morcellator
  • Ethicon Gynecare – X-Tract
  • Ethicon Gynecare – Morcellex Tissue Morcellator
  • Johnson & Johnson/Ethicon – Morcellex Sigma
  • Interlace Medical – Hysteroscopic Morcellator
  • Smith & Nephew – Trueclear Hysteroscopic Morcellator
  • Olympus – PlasmaSORD
  • Olympus – Gyrus PKS PlasmaSORD
  • Nouvag – Morcellator TCM3000BL
  • Blue Endo – MOREsolution Tissue Morcellator
  • LiNA Medical – Xcise Cordless Laparoscopic Morcellator
  • Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
  • Richard Wolf – Morce-Power 2306 Electronic Morcellator

Case Review Focus Areas:

  1. Indication for OBGYN Surgery – i.e. Hysterectomy? Fibroid Removal? Uterine Cancer – known or suspected?
  2. Was Laparoscopic Power Morcellator Surgery the best available treatment option? Were other options discussed with patient?
  3. Was benefits and risk of morcellator surgery discussed with patient?
  4. Was morcellator used during surgery? – Identify manufacturer and product
  5. Did the patient develop cancer after the morcellator surgery? – Leiomyosarcoma (LMS), Uterine Sarcoma, Myelosarcoma, Uterine Cancer etc
  6. When and where was the cancer diagnosed, pathological findings?
  7. Treatment/management of cancer, and its complications.
  8. Follow-up visits for cancer, surgical treatment/management
  9. Outcome/prognosis – spread of cancer
  10. Any recurrence of cancer?
  11. Any prior medical/surgical history of uterine cancer, fibroids?
  12. Any family history of uterine cancer or other cancers?

Specific Focus

Identify and report cases with the following scenarios:-

  1. No Injuries: Patient underwent hysterectomy with use of power morcellator but did not develop any cancer (no injury – case screening)
  2. No Morcellator use: Patient underwent hysterectomy but Morcellator was not used
  3. Injury present even before surgery: Patient had Uterine cancer even before morcellation surgery

Identify and report on missing medical records

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.