'The Dr. Oz Show' reached out to Johnson & Johnson and asked them the following question.
- Why did you remove your power morcellation devices from the market?
- Was the power morcellation device manufactured by Johnson & Johnson a risk to women who have received hysterectomies or myomectomies in the past using the devices?
- What is your position on its use and safety for women to remove fibroids in or on the uterus?
In response to our questions, Johnson & Johnson responded with the following letter regarding the device manufacturer Ethicon, a fully owned subsidiary of Johnson & Johnson:
At Ethicon, our first priority is to our customers and patients. As an expansion of our April 2014 global commercial suspension, Ethicon recently decided to initiate a worldwide voluntary market withdrawal of all Ethicon morcellation devices that currently remain in the market. (Important Note: This is a voluntary product withdrawal (not a recall) under FDA regulations because it is not related to how the product performs. The product performs as intended. )
The withdrawn products include: GYNECARE MORCELLEX™ Tissue Morcellator, MORCELLEX SIGMA™ Tissue Morcellator System and the GYNECARE X-TRACT™ Tissue Morcellator.
For background, we suspended global commercialization (sales, distribution, and promotion) of our morcellation devices in April 2014 while the role of power morcellation for patients with symptomatic fibroid disease was evaluated by the FDA and the medical community.
The complexity of this issue was further reinforced at the July 10-11 U.S. Food and Drug Administration (FDA) Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, particularly with respect to:
- The difficulty for medical professionals to preoperatively diagnose some malignancies, leiomyosarcoma in particular
- The risk of disseminating unsuspected malignant tissue while using power morcellation devices
- Methods to mitigate this risk
We believe Ethicon morcellation devices perform as intended and that there are patients who can benefit from procedures using laparoscopic power morcellators. However, the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.
Due to this continued uncertainty, 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. We remain committed to advancing the standard of care for women’s health and will continue to monitor and evaluate this important issue.