A new litigation regarding gynecological devices has emerged over the past couple of months involving power morcellators. Much like the birth control and transvaginal mesh cases, the injuries are devastating. On April 17, 2014, the FDA issued a safety communication discouraging the use of uterine procedures. Specifically, the FDA warned that “when used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancer tissue, notably uterine sarcomas, beyond the uterus.”
On July 10 and 11, 2014, the FDA held an advisory committee meeting, in which panel members discussed placing more stringent labeling on the morcellator devices to properly warn patients of the risks of uterine sarcoma. Interestingly, shortly after the FDA’s advisory hearings, one of the manufacturers, Johnson & Johnson, removed its morcellator devices from the market on July 30, 2014.
Morcellation has always been a common practice in laparoscopic surgery but has recently come under question for use in gynecological procedures. Essentially, the morcellator cuts fibroid or uterine tissues into small pieces for extraction during surgery. Power morcellators are used most frequently during laparoscopic and robotic-assisted hysterectomies and myomectomies. The use of morcellators has greatly increased during laparoscopic surgeries because it offers less painful recovery and fewer wound complications. While the exact use of morcellators is unknown, it is estimated that approximately 20,000 laparoscopic and robotic hysterectomies are performed utilizing the morcellators.
If you or a loved one has experienced complications or injuries as a result of a power morcellator, contact our attorneys today. Call us at (855) 400-4174 for a free case evaluation and learn how we can help you.
History of Power Morcellators
- It is believed that tissue removal devices were developed as early as 1973.
- The first electric morcellator was approved for use in 1993 by the FDA through its 510(k) approval process. The device name was Cook Tissue Morcellator and it was manufactured and developed by Cook Urological, Inc.
- After the Cook Tissue Morcellator came on the market, Gynecare Innovation, which would later be purchased by Ethicon, a subsidiary of Johnson & Johnson, developed a Femrx Operastar System Morcellator predicated on previous morcellator devices. The device was approved on March 14, 1996.
- The device name was later changed to Gynecare X-tract. Ethicon received approval for its second device, the Gynecare Laparoscopic Morcellator on February 7, 2000. As the 510(k) application states, “no clinical data was deemed necessary to support this premarket notification.”
- On July 14, 2006, the FDA approved Ethicon’s Gynecare Morcellex Tissue Morcellator, which is predicated on the original Gynecare X-Tract Tissue Morcellator from 1996.
- In 2010 and 2013, Ethicon developed two other morcellator devices. Notably, the device approved in 2013, Morcellex Sigma Generator, was predicated on the Gynecare X-Tract device from 1996. The mere fact that a device developed in 2013 is predicated on a device that was approved almost 20 years previously should cast significant concerns regarding the 510(k) approval process.
Power Morcellator Injuries
Of greater concern is the fact that a review of the Manufacturer and User Facility Device Experience (MAUDE) database of the U.S. Food and Drug Administration found 55 complications from 1993 through 2013 including 6 deaths and injuries caused by the morcellator blade.
These injuries do not include reports of uterine sarcoma, including leiomyosarcoma (“LMS”), a serious form of cancer that is often fatal. While the incidence of uterine sarcoma attributed to this device is unclear, the FDA estimates that 1 in 350 women undergoing hysterecotomy or myomectomy for treatment of fibroids is found to have an unsuspected uterine sarcoma. This is in contrast to a recent statement by the Society of Gynecologic Oncology, which estimated that fewer than 1 woman in 1000 who undergoes a hysterectomy will develop a leiomyomata. One of the primary concerns regarding uterine sarcoma is that there are no good methods to screen for it.
While the litigation is just commencing, there have been reports that a pathologist warned Johnson & Johnson in 2006 that the morcellators carried significant risks. Additionally, an article published on November 26, 2012, examined 1091 instances of uterine morcellation from 2005 to 2010 and revealed a high rate of unexpected sarcoma after morcellation. The article found that there was a 9-fold higher rate of unexpected sarcoma than what had been advised to patients prior to the procedure.
Power Morcellator Lawsuits
Once a preliminary evaluation is done on your case, you will receive a packet. The packet contains a contract, questionnaire and authorization. This information is necessary to further evaluate your claim and to obtain your medical records. Obtaining your medical records can take 3o to 60 days. After the medical records are retrieved, an attorney will review your records and a determination will be made on your case.
If your case is accepted, a lawsuit will be filed. Pharmaceutical and medical device cases are frequently grouped together or “consolidated” in one court before one judge. This helps the discovery process proceed more quickly and efficiently. These consolidations are known as “MDLs” or Multi-District Litigation. An MDL is not a class action. Your case will be evaluated, tried and ultimately settled on the merits of your particular case.
If you or a loved one has developed uterine sarcoma as a result of the power morcellator, please contact our law firm. We have significant experience handling pharmaceutical injury cases. We handle all cases on a contingency meaning that we don’t get paid unless we win.