Recalls of Power Morcellators
Every day, women from all walks of life discover they have a problem associated with their reproductive system. Symptoms may include heavy and frequent periods, pain during sex, back discomfort, or a prolapsed uterus. Often, these are signals of a greater underlying problem, such as cancer or tumors. When this is the case, doctors typically prescribe a hysterectomy to remove a portion or all of the uterus (or whatever area of the reproductive system is cancerous such as the ovaries, fallopian tubes, or cervix). When tumors are present (referred to as fibroids), doctors recommend a procedure known as myomectomy.
To accomplish either of these surgeries, doctors often use morcellators. Since their invention over twenty years ago, they have gained significant popularity across the medical community. Their prevalence is in large part due to their actual makeup. The device consists of a skinny, crane-like arm with a hallow interior. This allows surgeons to operate with minimal impact upon entry with the device and perform surgery far away from the actual access point. The entire process is known as laparoscopic morcellation and is often preferred because of its lack of invasiveness.
FDA Warns Against Laparoscopic Morcellation
However, there are significant problems associated with morcellators. The most important of which concerns its actual operation. The morcellator works by mincing up and removing the affected body part. Numerous studies have shown that this process might increase the risk that cancer, already present in women (approximately one out of three hundred and fifty)), might spread. Other related concerns are that laparoscopic morcellation adds time to surgery and complications if multiple entry points are required.
As late as April of 2014, the U.S. Food and Drug Administration (FDA) shared these exact concerns and provided guidance to health care providers as well as women with respect to understanding the nature of the dangers posed by morcellators. Finally, it recommended to morcellator manufacturers that they include a warning label on the device itself, which should read as follows:
“The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
The FDA renewed and updated its concerns regarding laparoscopic morcellation in November of 2014.
Morcellator Manufacturers’ Response
After the government, numerous studies, and prominent organizations all voiced strong concerns suggesting a link between laparoscopic morcellation and the spread of cancer, leading manufacturers of the device began to reconsider their production of morcellators. These companies include Ethicon, Lumenis, Olympus, Richard Wolf, and Blue Endo. Ethicon, which is owned by Johnson & Johnson, went a step further and suspended sales of all of its power morcellators. It did this while noting that it was waiting for the FDA to clarify the role of laparoscopic morcellation in the spread of uterine cancer and fibroid disease. Thus, this suspension might only be temporary.
Also, this is not a recall. Morcellators in circulation are free to be used by health care providers free of penalty and these companies have not called for their return due to systemic risk. However, Johnson & Johnson’s Ethicon took an extraordinary-and voluntary- step in April of 2014 by recalling three of its own morcellators from hospitals around the world. Yet, it is unclear whether other manufacturers will make the same decision.
The Medical Community Responds
Largely following the lead of the FDA, several groups and individuals in the medical community have recently expressed concerns regarding the use of laparoscopic morcellation in hysterectomies and myomectomies. One of the more prominent organizations, the American College of Obstetricians and Gynecologists, urged patients to proactively learn more so that they can better protect themselves from the risk of cancer spreading in their body.
In a statement, it said that, “It is important for each patient and her doctor to communicate fully about the risks and benefits of all procedures, including surgical options, so that she is able to make an informed and voluntary decision about the care that she receives.” It also went on to recommend health care providers to screen patients for the presence of cancer prior to performing laparoscopic surgery and to adequately inform them of alternative procedures.
Hospitals have also responded to the growing debate connecting laparoscopic morcellation and cancer and other diseases. Several highly visible and respected institutions have independently discontinued the use of power morcellators in hysterectomies and myomectomies. Some of these include Boston, Brigham and Women’s/Massachusetts General, and the Cleveland Clinic. Other establishments, such Temple University Hospital, have started to alter the application of the morcellator to prevent the spread of cancer (often by using a bag to isolate the procedure from the rest of the body). However, many other hospitals and medical institutions have simply stayed the course and continued using morcellators in the face of FDA and academic uncertainty.
Do You Have Questions About Your Legal Rights?
Rosenfeld Injury Lawyers LLC is actively investigating cases on behalf of women injured by power morcellator devices. If you would like to speak to an attorney who has experience with this litigation, contact us anytime to arrange a free consultation.