Power Morcellator Recall Issued by Ethicon Due to Cancer Risk During Uterine Fibroid Surgery
Johnson & Johnson’s Ethicon subsidiary has announced a uterine fibroid morcellator recall, finally acknowledging that the cancer risk associated with using their device during a laparoscopic hysterecomy or myomectomy surgery is too great.
The move comes amid a growing number morcellation cancer lawsuits being filed by women throughout the United States who underwent a minimally invasive hysterectomy or uterine fibroid removal surgery, and were then diagnosed with:
- Endometrial Stromal Sarcoma
- Other Cancer Spread Throughout the Body
This is big news, as Ethicon was the largest manufacturer of uterine fibroid power morcellators, aggressively marketing the devices for years without providing doctors or patients information about the potential risk of quickly upstaging cancer.
The recall comes shortly after a two-day meeting of the FDA’s Obstetrics and Gynecology Devices advisory panel on July 10 and 11, where a growing number of critics were calling for the FDA to recall morcellators manufactured by Ethicon and other companies.
The FDA Panel meeting was scheduled after the agency issued an April 17 warning to doctors, which urged them not to use power morcellators for uterine fibroid removal due to cancer risks.
Cancer Risk with Uterine Fibroid Morcellation
About one out of every 350 women who under go uterine fibroid morcellation surgery may have unsuspected sarcoma, where the cancer cells are contained within the uterus at a very early and treatable stage.
Unfortunately, there is no reliable way for doctors to diagnose this cancer before using a power morcellator to cut up the uterus or uterine fibroids into small pieces, allowing them to remove the tissue through a minimally invasive laparoscopic surgery.
For women with unsuspected sarcoma who have morcellation surgery, this cancerous tissue may be spread throughout the abdomen, quickly upstaging the uterine cancer and greatly reducing their chances for long-term survival.
Officials at Johnson & Johnson’s Ethicon subsidiary sat in on the hearing, and now appear to be acknowledging the serious risk their devices pose for women. Several recent media reports suggest that the company sent text messages and emails to doctors nationwide this week, requesting that they voluntarily return all power morcellators manufactured by Ethicon.
Since about 72% of all power morcellators used in the United States were manufactured by Ethicon, which means that nearly three quarters of power morcellators are being recalled. Many other manufacturers may soon follow suit, bringing an end to the number of women unnecessarily having aggressive cancer spread throughout their body.
Have You or a Loved One Been Diagnosed with Cancer Following Uterine Fibroid Morcellation?
For years, Johnson & Johnson and other power morcellator manufacturers, knew or should have known that their products may spread uterine cancer. Rather than investigating the issue or warning doctors and consumers, they promoted the devices as safe and effective.
Some manufacturers did hope that the addition of surgical bags to collect tissue debris during uterine fibroid morcellation surgery may reduce the risk of spreading cancer cells. However, it has become clear that even if these morcellator bags were provided with the device, the risk of cancer is too great to justify the benefits associated with the laparoscopic or robotic surgery.
The bags are not only difficult to handle and use, but can be torn by the morcellator’s spinning blades easily. Therefore, even using them is no guarantee against the spread of cancer cells. The FDA advisory committee determined that there was no way to use power morcellators safely, likely putting the final nail in the coffin for this profitable product line for Johnson & Johnson’s Ethicon division.
Power Morcellation Recall Lawsuits
The product liability lawyers at Saiontz & Kirk, P.A., are reviewing lawsuits from women who have been diagnosed with advance staged uterine cancer, such as sarcoma or leiomyosarcoma, following power morcellation to remove uterine fibroids.
Free consultations and claim evaluations are provided to help women and families nationwide determine whether this device may have been used during a laparoscopic hysterectomy or myomectomy in recent years.
All cases are reviewed by our morcellator recall lawyers under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our law firm and we receive no attorney fees unless a recovery is obtained.