The biggest for-profit hospital operator in the country, HCA Holdings, recently announced that power morcellators will no longer be used to remove uterine fibroids in its hospitals.Uterine cancer lawyers at Pintas & Mullins Law Firm explain why this announcement was made and how it will impact patients.
Power morcellators have just recently come under public scrutiny – most Americans had no idea what they were until about a year ago. A laparoscopic power morcellator is used in several types of minimally-invasive surgeries, to pulverize tissue before it is removed from the body through a small opening. In women, power morcellators are often used during hysterectomies or myomectomies, which are surgeries to remove the uterus or uterine fibroids.
Morcellation refers to the process of breaking down tissue to make it easier to remove through a small incision, which is why most physicians recommended this type of procedure over more invasive alternatives. Very few doctors were concerned about the risks of morcellation, believing the adverse events were too few and far between.
Now, mounting evidence to the contrary has prompted hospitals, doctors, medical journals, and even the FDA to issue warnings against power morcellation. In mid-November, 2014, the FDA released its strongest warning against power morcellators, urging doctors not to use them during hysterectomy or myomectomy surgeries. The agency also ordered new a“black box” warning label the device.
HCA hospitals, which runs 165 hospitals and 113 surgical centers, now prohibits the use of power morcellators. Many other hospitals have implemented similar bans.
The strengthened warnings and bans against these devices are in response to the potential for morcellation to spread undetected uterine cancer. During the morcellation procedure, the device breaks up the uterine tissue – which may or may not have undetected cancer cells – spreading it throughout the uterus. If there is cancer present, and the FDA estimates that about 1 in every 350 women do have uterine cancer tissue, morcellation would spread that cancerous tissue, seeding it in the uterus and abdomen.
Cancer is much more deadly when it has spread. Therefore, for women who do have undetected cancer, the likelihood of long-term survival is significantly decreased after a morcellation procedure. Making matters worse, there is no test or other method to predict whether a woman would have cancerous tissue in her uterus before such a procedure.
Now that this potential has come to light, cancer patients and their families have started coming forward, telling their devastating stories. In nearly every situation, the patient was never told about the risk of cancer when deciding to undergo her surgery, and some did not find out that power morcellators were to blame until long after their diagnosis.
The FDA now strongly encourages doctors to discuss the risks and benefits of hysterectomies and myomectomies, including all available treatment options. There are many alternatives to power morcellation procedures that must be considered, such as traditional surgical hysterectomy, myomectomy without morcellation, laparoscopic hysterectomy, and laparotomy.
Johnson & Johnson recently recalled its power morcellator devices globally, and hospitals throughout the country have suspended use as well. There have been several lawsuits against power morcellation devices, filed by women and families affected by cancer diagnoses.
Our team of uterine cancer lawyers is currently investigating cases of cancer after morcellation procedures. If you or someone you love has been affected by this devastating illness, contact our firm immediately. Our case reviews are always free, confidential, and available to potential clients nationwide.