Statement from Johnson & Johnson

Producers of 'The Dr. Oz Show' reached out to representatives from Johnson & Johnson to respond to statements made on the show.

Statement from Johnson & Johnson

'The Dr. Oz Show' reached out to Johnson & Johnson and asked them the following question.

  1. Why did you remove your power morcellation devices from the market?
  2.  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?
  3.  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The withdrawn products include: GYNECARE MORCELLEX™ Tissue Morcellator, MORCELLEX SIGMA™ Tissue Morcellator System and the GYNECARE X-TRACT™ Tissue Morcellator.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.

4 Steps to Shedding Your Pandemic Pounds

Forgive yourself, and start walking toward a healthier you.

For those of you who have put on the Pandemic Pounds or added several new COVID Curves, you are not alone. Alarmingly, the American Psychological Association has recently published that almost half of all adults in their survey now have a larger physique. In fact, 42% of people reported gaining roughly 15 pounds (the average published was surprisingly 29 pounds but that included outliers) over the past year. Interestingly, 20% of adults in this survey lost about 12 pounds (I am surely not in this group). Clearly, there is a relationship between stress and weight change. In addition, one in four adults disclosed an increase in alcohol consumption, and 67% of participants distressingly revealed that they have new sleeping patterns.

This past year has brought about what has been called the 'new normal.' Social isolation and inactivity due to quarantining and remote working have sadly contributed to the decline in many people's mental and physical health, as demonstrated by the widespread changes in people's weight, alcohol consumption, and sleeping patterns. Gym closures, frequent ordering of unhealthy takeout, and increased time at home cooking and devouring comfort foods have had a perceptible impact. In addition, many people have delayed routine medical care and screening tests over fear of contracting Covid-19 during these visits. Unfortunately, the 'new normal' has now placed too many people at risk for serious health consequences, including heart attacks and strokes.

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