Women throughout the country undergo hysterectomies and fibroid removals every day. But the Food and Drug Administration (FDA) has recently decided to schedule a panel advisory meeting about power morcellators, a surgical tool used in laparoscopic gynecological surgeries. This comes after the FDA’s warning in April that the use of such tools in the removal of fibroids could lead to the spreading of uterine sarcomas.
The danger of power morcellators
It’s important to note that power morcellators do not cause cancer; what they do is allow undetected cancerous cells to spread, most commonly to the pelvis or abdomen. When the sarcomas spread, it decreases a patient’s chances for long-term survival.
In response to the lawsuits, Ethicon Inc., which is part of Johnson & Johnson, immediately stopped the sales and distribution of their new power morcellators around the globe. The tools in questions are:
- Gynecare Morcellex Tissue Morcellator
- Morcellex Sigma Tissue Morcellator System
- Gynecare X-Tract Tissue Morcellator
What Ethicon did not do is recall any existing morcellators, meaning that patients who have undergone a hysterectomy or a fibroid removal procedure may be at risk, since Johnson & Johnson claims that the existing products are fine and therefore will not recall any of them.
What happens next
The class-action lawsuits have already begun, of course, though how many of them there will be remains to be seen. For patients who underwent morcellation, it is imperative that you visit your doctor quickly; since it’s suspected that 1 in 350 women who undergo the process may have undetected sarcomas, you want to detect any problems as soon as you can.
Whether or not Ethicon Inc. had any notion of the potential problems, or whether any prior knowledge can be linked to its parent company Johnson & Johnson, is also unclear right now. Cases involving medical product liability are particularly tricky, and may require years of lawsuits even if the plaintiffs agree to take a settlement.
For more information on medical malpractice, we invite you to visit our website at Plaxen & Adler, P.A. There, you can take a more in-depth look at what constitutes a medical malpractice case, and read about other services we offer to personal injury victims throughout the state of Maryland.