Cindy: A morcellator is a surgical instrument that is commonly used in laparoscopic surgery where a large mass needs to be extracted. The morcellator breaks the large mass into small specimens so that it can be removed in a minimally invasive way. However, there are some significant safety concerns in using a power morcellator in gynecologic surgery. These concerns include the potential spread of cancer cells because of this the FDA has discouraged its use for uterine procedures and issued a warning that morcellators may spread occult cancer in the course of fibroid removal.
Houston attorney, Terry Bryant, is here today to answer questions related to this topic. So, Terry, thank you for being with us today.
Terry: Thank you for having me.
Cindy: Well, Terry, help us understand the concern here as we want to educate women but not unduly alarm every woman that has had uterine surgery.
Terry: The concern here is for woman who have had a hysterectomy or myomectomy, power morcellators were used in as many as 600,000 hysterectomies a year. It is technically simple technology but researchers now recognize serious complications associated with it. About 1 in 350 women has an undiscovered aggressive cancer in the uterus even with like pre-treatment screening these aggressive tumors can be almost impossible to detect. If a cancer is released during the procedure it can spread these aggressive cancer cells throughout the abdominal cavity.
Cindy: Well, I understand that Johnson & Johnson suspended sales of their device. Is there a reason to suspect that the device should not have been on the market in the first place?
Terry: Well, anytime that a company suspends sales of their device in the midst of complications traced back to it, there’s reason to suspect that the device should not have been on the market in the first place. Perhaps these injuries could have been avoided through a more thorough testing process prior to releasing the device in the market. In fact many lawyers think that the device manufacturers fail in their duty to provide a safe product and even continued to sell the product after it was cleared that it wasn’t safe.
Cindy: Terry, who needs to be aware of this? Is it any woman who has had a hysterectomy and later been diagnosed with cancer?
Terry: That’s right, Cindy. Awareness is the key to identifying those women affected by this terrible complication. This can be accomplished by educating the medical professionals in directly notifying the women, the ones who had this type of surgical procedure and then were diagnosed with cancer.
Cindy: Well how about those women that are facing uterine surgery, what should they know and discuss with their surgeons prior to undergoing the procedure?
Terry: Well the good news is that the power morcellator wasn’t used in all of these surgeries. They should ask their surgeons whether a power morcellator was used and then discuss the potential complications. It might be wise to explore an alternative surgical option before considering to a procedure that utilizes the power morcellator. And I don’t want to unduly alarm women but it’s just an item that are discussed with their surgeon as they go in for their test, have routine follow-ups, and that sort of thing. If they think they have been affected by an unsafe device they should probably contact a board certified attorney to discuss the potential claim
Cindy: Right. Well, this is great information and, Terry, thank you so much for your time today.
Terry: Well, thanks for having me.
Cindy: Until next time. This is Cindy Speaker for Texas Law TV.
For more information please visit our website at https://www.terrybryant.com/product-liability/defective-medical-device.