About Power Morcellator
Power morcellators are medical devices used in laparoscopic hysterectomies or myomectomies, which let surgeons cut up uterine fibroids through a small incision. On one hand, these devices allow for a less invasive surgery with a lower risk of infection, bleeding and scarring, in addition to a shorter recovery time.
However, concerns have emerged that some women undergoing the procedures may end up with unsuspected sarcoma (cancer) within their uterus. It is believed morcellation causes contained cancer cells to spread throughout their body, increasing the risk of premature death.
According to Modern Healthcare magazine, the decision to remove morcellation devices from the market altogether is controversial. The Society of Gynecologic Oncology wrote a letter to the FDA stating that the studies are “questionable” and that “banning morcellation may cause more harm to more women” because the tool has enabled women to undergo minimally invasive procedures, rather than riskier open procedures.
The history of power morcellation dates back to 1995.
- 1995: The FDA approves the first laparoscopic power morcellator (made by Karl Storz) through the 510(k) process. Since then, the agency has approved of two dozen more devices for use in gynecology.
- 2009: The American College of Obstetricians and Gynecologists (ACOG) issues a statement that evidence points to better outcomes and fewer complications with vaginal hysterectomy, rather than laparoscopic or abdominal hysterectomies.
- 2012: A review of 1,091 medical records published in PLOS ONE concludes that the rate of unsuspected leiomyosarcoma is 0.09% — nine-fold higher than the 1-in-10,000 ratio reported to patients during pre-surgical consultations.
- 2013: Dr. Amy Reed, a Boston-based anesthesiologist, finds out she has a cancerous mass after undergoing power morcellation at Brigham and Women’s Hospital and begins a very public campaign against morcellation. The Wall Street Journal published a debate-sparking article about the pros and cons of morcellation, prompting discussion among hospital administrators. The Society of Gynecologic Oncology published a statement that morcellation shouldn’t be used in patients with premalignant conditions and that patients should be more informed of the risks prior to surgery. The FDA starts to review data on morcellator use.
- 2014: The American Association of Gynecologic Laparoscopists announces they are creating a task force to examine the risks of power morcellation. An article published in JAMA recommends creating a nationwide registry of gynecologic surgeries to assess complications associated with power morcellation.
Finally, on April 17 2014, the FDA discourages the use of morcellators in most hysterectomy and myomectomy procedures due to the risk of spreading unsuspected cancerous tissue. After reviewing the current literature, the FDA concludes that the risk of spreading unsuspected uterine sarcoma is 1 in 352. Therefore, they recommend that laparoscopic power morcellators no longer be used for patients with uterine fibroids.
Who makes morcellators?
Johnson & Johnson (Ethicon) is the biggest name in morcellators, estimated to account for about two-thirds of the U.S. market. Brand names include: Gynecare Morcellex, Morcellex Sigma, Gynecare X Tract, and Diva. The company issued a “voluntary” recall of morcellators manufactured by subsidiary Ethicon, requesting that surgeons to return the devices after the FDA issued warnings about the risk of spreading undetected uterine sarcomas.
Other makers and models of morcellators include:
- Blue Endo – MOREsolution
- Cook Urological – Cook Tissue Morcellator
- Gyrus – ACMI LP
- Karl Storz – ROTOCUT G1, G2, Swalhe II SuperCut Morcellator
- KSE America – Steiner Electromechanic Morcellator
- LiNa Medical – Xcise
- Lumenis Ltd – VersaCut+Tissue Morcellator
- Olympus – PKS PlasmaSORD, VarioCarve Morcellator
- Richard Wolf – Morce Power Plus
- Smith & Nephew – TRUCLEAR Morcellation System
- Trokamed – GmbH
Side effects and symptoms associated with morcellation
According to Contemporary OBGYN, limited reporting makes the rates of injury among morcellation patients difficult to quantify. However, a review of published articles and the FDA device database identified at least 55 morcellator injuries. The most common complications were vascular tissue and bowel injuries, with surgeon inexperience a major contributing factor.
Beyond surgical precision, there is also concern about “the dissemination of tissue” during the power morcellation process. Fragments of tissue can be spread around the body, which can result in pain, infection, or even death – particularly if these tissues contain cancerous cells.
Patients should look out for adverse side effects like:
- Bleeding, pain and infection at the incision site
- Soreness, bruising and abscess formation
- Fibroid recurrence
- Intense, prolonged pain in the pelvic region and abdomen that may indicate organ damage
Morcellation & uterine cancer risk
The Wall Street Journal reports that the risk of women with fibroids having sarcoma was believed to be 1 in 10,000 – so small a risk that surgeons rarely mentioned it to patients. In April, the FDA said women undergoing surgery for fibroids actually have a 1 in 350 risk that the growths are cancerous. A similar study by Columbia University found that 1 in 368 women undergoing hysterectomies have hidden leiomyosarcoma that a morcellator may spread throughout the body.
The report in the Journal of the American Medical Association was the largest assessment yet of the device’s risk, and examined the records of a much larger group of women than the FDA did in its main analysis. The study also concluded that the surgical device has the potential to spread more types of uterine cancer in a woman’s body than previously thought.
Hospitals like Massachusetts General, Brigham and Women’s Hospital, and Temple University Hospital tried using small bags attached to the device to contain the shredded tissue. However, there is no proof that this technique is actually effective.
“I think there was consensus in that we have so many questions and incomplete answers,” Dr. Michael Neuman of the Michigan Technological University Center told The Boston Globe. Later, many of these same medical institutions opted to ban the devices, rather than continuing to take a stab in the dark at fixing the hazard.
Morcellation cancer lawsuits
The morcellation cancer lawsuits are starting to pile up.
- On October 9, Lisa Nielsen and her husband, Kurt, who filed a morcellation cancer lawsuit against Gyrus ACMI. Lisa found she had cancer that spread throughout her abdomen more than a year after uterine fibroid surgery.
- On October 10, a wrongful death complaint filed against Ethicon and Karl Storz by the family of Patricia Daley was removed from Maryland state court to the federal court system. The lawsuit alleged that the decedent developed a particularly aggressive form of uterine cancer that claimed her life five months after her 2011 procedure.
- Florida resident Peggy Paduda filed a lawsuit against Karl Storz after she was diagnosed with a rare, deadly and pervasive cancer less than a year after her 2013 hysterectomy. Her claim states that the defendants “failed to make the instrument safe for its intended use.”
- Brenda Leuzzi of New York was diagnosed with acute uterine cancer shortly after undergoing a hysterectomy performed with a power morcellator. The lawsuit alleges that Ethicon failed to warn her about the risks and complications associated with the device used in her procedure.
Can a morcellation lawyer help?
Anyone diagnosed with uterine fibroid surgery cancer where a power morcellation device was used may be eligible to file a lawsuit. Family members of the deceased may also file a wrongful death suit.
Qualified morcellation attorneys offer a free consultation to all people who feel they have a legitimate claim. Given that there is so much inquiry into the safety of morcellation devices, we are likely to see many more lawsuits filed and even consolidated in federal court in the very near future.
- Modern Healthcare - Senators call for FDA action on power morcellators as controversy continues http://www.modernhealthcare.com/article/20140820/NEWS/308209948
- The Washington Post - Johnson & Johnson pulls power morcellator; surgical device had sparked controversy http://www.washingtonpost.com/business/economy/johnson-and-johnson-pulls-power-morcellator-a-controversial-surgical-device/2014/07/30/738e9956-1829-11e4-9e3b-7f2f110c6265_story.html
- Wall Street Journal - Johnson & Johnson Pulls Hysterectomy Device From Hospitals http://online.wsj.com/articles/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350
- Contemporary OBGYN - Power morcellation for uterine fibroids: What you need to know http://contemporaryobgyn.modernmedicine.com/contemporary-obgyn/news/power-morcellation-uterine-fibroids-what-you-need-know?page=full
- Medscape – The Morcellation Controversy: A Timeline http://www.medscape.com/viewarticle/824081
- Boston Globe - No agreement reached on whether FDA should ban hysterectomy cutting tool. http://www.bostonglobe.com/lifestyle/health-wellness/2014/07/11/agreement-reached-whether-fda-should-ban-hysterectomy-cutting-tool/osqF6JsBWdjLLZ8pPc5UHP/story.html