The FDA last week for the first time discouraged doctors from using morcellators when performing hysterectomies. The FDA also said morcellators should be avoided when removing uterine fibroids. The concern is that if there is cancerous tissue in the abdomen, it will hurt a patient’s chance of recovering from the cancer. In some cases, surgeons can be stirring up cancer that neither the doctor or the patient even knows exists. How real of a concern is that? The FDA says that 1 in 350 women who are undergoing a hysterectomy or myomectomy for fibroids have a uterine sarcoma, an unsuspected type of uterine cancer that can be deadly.
What is a morcellator?
A morcellator is a surgical device that is used to divide and remove tissue masses during laparoscopic surgery. In a hysterectomy, the device divides the uterus. It is also frequently used to dissect uterine fibroids during myomectomies/fibroidectomies.
This surgical device cuts the tissue mass into pieces. The surgeon then pulls out the pieces through extremely small incisions. There is no question there is an upside to this technique. It is minimally invasive surgery which means no big scars, shorter recovery time, and less of the other risks that come with surgery.
So the FDA’s announcement is a major development. Morcellators are being used in massive numbers. It is used in tens of thousands of hysterectomies each year.
Are morcellator cancer cases viable lawsuits?
It is easy for a trial lawyer to say that these are slam dunk lawsuits. But the reality is we really don’t know yet exactly what the manufacturers knew. So can I imagine a scenario where they are not responsible for cases where the cancer spreads? Sure.
But there are some things I can tell you. First, morcellators were approved under the FDA’s borderline criminal 510(k) procedure in 1995. This means that they never did real testing on it, they just grandfathered it in based on the fact that a similar device was on the market.
Second, they have almost 20 years of real live data on this. No one could figure this out over the last 20 years? It seems utterly ridiculous. If plaintiffs’ lawyers had jumped on this before the FDA, we would have been shot down as self-serving fools. I can hear it now, “C’mon this has been on the market for almost 20 years. You don’t think someone would have picked up on this by now if it were true?”
What should I do if I think I was hurt by a morcellator?
I think you should call a lawyer, either us or someone like us. Again, at the risk of being redundant, it is early in these cases. We don’t know quite how it will play out. But lawyers are jumping on these cases in massive numbers. Setting aside some very good lawyer jokes, here is a good reason for this. Some of these I highlight above. But, in short, where there is smoke there is fire and there are likely viable lawsuits here.