On Wednesday, pharmaceutical giant Johnson & Johnson announced plans to ask doctors to return all Ethicon laparoscopic power morcellators. The company is calling the voluntary move “a worldwide market withdrawal” of Ethicon morcillation. Ethicon, a division of Johnson & Johnson, is one of the largest manifucturers of the devices in the United States. The company cited an FDA meeting that occurred earlier in July that reinforced “the complexity of this issue.”
In April of this year, the U.S. Food and Drug Administration advised that doctors not use power morcellators pending an FDA investigation. At that time, Johnson & Johnson suspended sales and distribution of its morcellation devices. Many hospitals suspended use of the devices as well.
Laparoscopic power morcellators are used in hysterectomies and myomectomies to cut up fibroid growths to facilitate their removal in non-invasive procedures. Morcellators use tiny blades to “mince” uterine tissue into very small pieces. Morcellator use can speed patient recovery time and limit blood loss and infection. The danger is that previously undetected malignant masses can be present. Use of a morcellation device in those patients can spread the cancer throughout the abdomen. Prior to the FDA advisory, morcellators were used in approximately 100,000 procedures a year. An estimated 250 women develop late-stage cancer annually due to power morcellator use.
In an emailed statement, company spokesperson Matthew Johnson said “Due to this continued uncertainly, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.”
The Ohio Morcellator Injury Attorneys at Clark, Perdue & List are investigating claims for personal injury and wrongful death. If you or a loved one has been diagnosed with cancer following a procedure using a morcellation device, contact Clark, Perdue & List.