Pittsburgh Product Liability Lawyers Discuss Dangers of Power Morcellators
Power Morcellators Simplify Surgery
Power morcellators were introduced as a way to simplify certain surgical procedures, mainly hysterectomies, which involve the removal of a woman’s uterus, and myomectomies, which is the removal of benign fibroid tumors within the uterine wall. Prior to the introduction of laparoscopic morcellation, hysterectomies required extensive surgery, often with a long incision across the pelvis. The recovery time for this type of surgery was an average of six to eight weeks, and the risk of complications was long. Post-surgical pain, infections, cellulitis and problems with prolonged anesthesia during the surgery were heavy burdens for many patients.
Science soon offered an alternative to traditional surgery. A power morcellator is an instrument with a spinning blade that is used to break up uterine tissue and fibroids so that they can be extracted laparoscopically through a small incision in the abdomen. Surgeons typically performed hysterectomies and myomectomies using a scalpel to break up the fibroid tumors and the uterus before removing them. The power morcellator replaced this technique, pulverizing the uterine or fibroid tissue quickly and efficiently before being removed from the abdomen with a laparoscopic vacuum.
Risk of Metastasizing Cancer and Other Injuries Increase with the use of Power Morcellators
Power morcellators were not intended for surgeries to remove cancerous tumors or tissue. The high speed of the spinning blades can cause tissue to splash and be released into the surrounding area where the cancerous cells can begin to form another tumor. Gynecologic surgeons and patients were aware of this risk, but information available at the time the morcellators were introduced indicated a much lower chance of a woman having undetected cancer cells or malignant fibroids. Evidence now shows that one in every 350 women undergoing a hysterectomy or myomectomy has undetected cancer that can easily spread to other organs when power morcellators are used.
Other types of cancers have also been associated with the use of power morcellators. Surgeries to address ovarian cancer, kidney cancer and endometrial cancer have shown a propensity for metastasizing when power morcellators are used. Because cancer of these organs is often hard to diagnose before surgery, the risks of disturbing the undetected cancer cells are significant. Since the tissue is pulverized during morcellation, microscopic cancer cells can be spread throughout the abdomen. Many patients experience lower survival rates and have diminished quality of life following power morcellation.
Fifty-five additional complications associated with power morcellators have been reported in the Manufacturer and User Facility Device Experience (MAUDE). Injuries to organs such as the intestines, bladder, veins, arteries and the aorta have resulted from contact with the morcellator during surgery to other abdominal organs. Though most of these injuries resulted from operator error, the potential risks are cause for concern for even the most experienced surgeons.
The Food and Drug Administration (FDA) and Johnson & Johnson React to New Evidence
According to data reported on PubMed Central (PMC), approximately 600,000 hysterectomies and myomectomies are performed each year in the United States. It is estimated that 11% of these surgeries involved the use of power morcellators in the year 2010 alone. Almost 200 of these women had undetected cancer cells at the time of their surgery. Upon further investigation into the mounting reports and concerns about morcellators, the FDA publicly announced in 2014 that it was discouraging the use of all power morcellators.
Since that announcement, the FDA has recommended that a black box warning along with two contraindication warnings be placed on the packaging of all power morcellators to alert surgeons and patients of the dangers surrounding the use of these devices. In 2014, Ethicon, which is a subsidiary of Johnson & Johnson and the largest supplier of morcellators in our country, voluntarily recalled all of their morcellators, putting a stop to any future manufacturing or distribution of the product until further investigation could be done. Despite this worldwide recall, over 24 other morcellators are still available for sale and use by surgeons.
Pittsburgh Defective Device Lawyers at the Law Offices of James R. Moyles Help Victims Injured by Defective Products Claim Compensation
If you or someone you know has been diagnosed with cancer after having a hysterectomy or myomectomy using a power morcellator, you may be entitled to receive compensation. Medical bills, doctors, surgeries, therapies and lost wages can significantly impact you and your family’s financial health. Our team of experienced Pittsburgh defective medical device attorneys at the Law Offices of James R. Moyles is committed to helping our clients claim the maximum amount of compensation available to them.
Call us at 412-281-1055 or 717-233-5400, or complete our online contact form to schedule a consultation today. Our offices are conveniently located in Pittsburgh and in the Harrisburg area allowing us to serve clients throughout Pennsylvania, including Carlisle, Hanover, Linglestown, Hershey, Millersville, Lancaster, Gettysburg, Shippensburg, and York.