In July, 2014 Johnson & Johnson, the largest manufacturer of the surgical morcellator tool, sent letters to all customers asking the device be returned to its company. The laparoscopic power morcellator has recently come under fire when the FDA (Food & Drug Administration) issued a stringent warning last April. This is because the device is believed to spread previously undiagnosed cancer during hysterectomy surgery and procedures to remove uterine fibroids.
For nearly 2 decades, gynecologists have used the minimally invasive power morcellator device when performing hysterectomy surgeries and myomectomy procedures.
A power morcellator is a small device that has rotating blades designed to cut apart larger masses of uterine fibroid tissue into tiny fragments, which can then be suctioned out through the woman’s abdomen. The surgery requires only two small incisions (two centimeters or less) in lieu of performing traditional major invasive surgery.
Potential of Spreading Concealed Cancers
A hysterectomy is a surgical operation that removes part or all of a woman’s uterus. When cancerous cells are present in the tissue that is cut apart, cancerous cells can easily spread throughout the abdomen and pelvis. Recent investigations indicate that morcellation procedures are spreading bits of tumors from the treatment site, and actually worsening the damage caused by the cancerous cells. It is believed that in a few cases, the cancer spread at a faster rate because the woman underwent a procedure using power morcellation.
Two studies from Columbia University researchers and the FDA found that approximately one out of every 350 patients treated for fibroids using a morcellator had cancer. After undergoing minimally invasive hysterectomies, their undetected cancer spread throughout their abdomen and pelvis area. Doctors would have used a different treatment approach had they known the cancer was present.
Three J & J Morcellators Named In Recall
The company’s Ethicon unit has asked hospitals through a letter to return three specific power morcellators including:
• Morcellex Sigma Tissue Morcellator System
• Gynecare XTract Tissue Morcellator
• Gynecare Morcellex device
Johnson & Johnson announced all sales and marketing promotions of its morcellator products are suspended while the company studies the issue. Unfortunately, the company did not withdraw all devices from the market.
According to the FDA, more than 50,000 uterine fibroid removal procedures and hysterectomies involving power morcellation occur every year. The FDA also concluded that the potential risks of cancer spreading through the morcellation procedure, once believed to be one in 10,000, is actually approximately 1 and 350.
A Better Option?
Some doctors are cautioning media, agencies and medical device manufacturers from vilifying the procedure believing, if done carefully, it offers better options for some women. These doctors believe that the risks involved in serious abdominal surgery far outweigh the potential of spreading undiagnosed cancer because of associated surgery-induced blood clots, pain, bleeding and infection.
Minimizing Legal Ramifications
Johnson & Johnson may have taken quick action in having the device is returned to the company because of the high number of previous recalls of morcellation devices from other manufacturers. Many of these competitive devices have been withdrawn from the market because of the billions of dollars involved in legal settlements and court awards, along with bad publicity.
In the fall of 2013, Johnson & Johnson announced it was paying over $2 billion as financial compensation to approximately 8000 men and women who had suffered damages from the company’s hip implants. Johnson & Johnson also faces tens of thousands of lawsuits for its pelvic mesh implant, which was withdrawn from the medical device marketplace in 2012. Reported sales of Johnson & Johnson morcellation products are not released from the company. However, they dominate the power morcellator market.
The procedure using the morcellation device is only one way for treating women requiring minimally invasive hysterectomies or uterine fibroid removal. In fact, out of a total number of fibroid removal or hysterectomy procedures, only 16 percent involve morcellation. Gynecologists often elect other options including removing the uterus or fibroid tumors through the vaginal canal.
Women requiring a uterine fibroid removal or a hysterectomy still have the option of undergoing laparoscopic or traditional surgeries without the need of using power morcellators.
For years, medical device manufacturers, doctors and others in the medical community have known of the potential risks involved in using power morcellators. However, only recently has the magnitude of the risks involved proven to be significantly higher than once thought. With the recall of other devices, and Johnson & Johnson asking medical health care providers to return their units, it seems inevitable that many more lawsuits will likely be filed in the future.