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Johnson & Johnson Withdraws Hysterectomy Device
- Updated: August 1, 2014
Johnson & Johnson announced on Wednesday that it is asked doctors and hospitals to return their power morcellators. It is a surgical device that is used during a hysterectomy. It has recently become controversial because the device might inadvertently spread cancer for patients being treated for uterine fibroids.
The Ethicon unit of the company suspended the sale and distribution of the devices while the medical community and the FDA investigated its role in treating symptomatic fibroid disease. The FDA advised doctors at the time to not use the device until there was further review.
Two recent studies by the FDA and Columbia University discovered that one in 350 women had cancer when they were treated for fibroids.
Women who had minimally invasive hysterectomies were one in 368. If a doctor was aware of the patient’s cancer then a morcellation would not be the appropriate treatment.
Power morcellators are used to perform a myomectomy or a hysterectomy. Morcellators are devices that have rotating blades to break up large masses into smaller pieces that can be vacuumed out of the patient’s body.
This allows surgeons to perform the procedure with an incision less than 2 centimeters, instead of a major abdominal surgery. If the patient unknowingly has cancerous cells in the tissue being broken up and isn’t removed completely, the cancer can spread.
On Thursday, Johnson & Johnson began reaching out to customers directly to ask them to return the devices in this worldwide withdrawal from the market.