The American Cancer Society states that the procedure is usually performed during a surgery to remove uterine lining and can be used in some gynecologic cancers, such as ovarian cancer. But experts say it’s not always necessary because other less invasive options are available, like laser ablation or cryoablation with liquid nitrogen.
The “power morcellator cancer lawsuit” is a legal case that has been filed against the device. The plaintiff, who is a woman, claims that her physician implanted the device in her uterus without her consent.
Power morcellators, which look like hand-held blenders and are used for minimally invasive surgical procedures, have been linked to the spread and worsening of cancer in women.
Suits have been filed against Johnson & Johnson and other manufacturers, claiming that power morcellators endangered women by spreading cancer.
Morcellators break down tissue into tiny pieces that may be removed from the body more readily via a minor incision. Morcellators, which are often used to remove uterine fibroids (myomectomy) or the uterus (hysterectomy), may enhance surgical results but can also spread undiscovered malignancy beyond the uterus, greatly lowering a patient’s long-term survival chances.
Morcellators with High Power
The separating of tissue into smaller pieces is referred to as “morcellation” in medical language.
Sharp, revolving blades at the end of a long tube crush up tissue with power morcellators, which are fashioned like drills. To execute “laparoscopic” (minimally invasive) hysterectomies and myomectomies, the blade end of the instrument is introduced via a tiny incision in the belly. After the tissue has been cut up, it is sucked out of the body through the tube.
Minimally invasive techniques are connected with fewer surgical problems and a speedier recovery than standard hysterectomy or myomectomy surgery, which require a significantly wider surgical incision.
Power morcellators were utilized in roughly 60,000 hysterectomies and myomectomies per year prior to the FDA’s warning in 2014. Other sorts of surgery, such as minimally invasive spleen and gallbladder treatments, make use of the gadgets.
How Can Strong Morcellators Spread Cancer?
At some time in their lives, most women acquire noncancerous growths known as “uterine fibroids.” Fibroids usually produce no symptoms, but they might develop problems (such as bleeding and discomfort) that demand surgical removal. Because of the surgical advantages of minimally invasive morcellation, many women choose to have their fibroid removed using a power morcellator.
However, around 1 in 350 women who have a hysterectomy or myomectomy for fibroid therapy have uterine sarcoma, which is a kind of malignancy, rather than benign fibroids. When women with undetected sarcoma have power morcellation, pieces of malignant tissue may be scattered throughout the abdomen and pelvis, spreading the disease and aggravating it unknowingly.
The risk of undiagnosed sarcoma in women was previously thought to be minimal (1-in-10,000), but an FDA review of presently available medical literature revealed that the true rate is significantly higher.
The Food and Drug Administration (FDA) has issued a warning about morcellators.
Power morcellators should not be used in hysterectomies or myomectomies, according to the FDA, “in the great majority of women.”
In an April 2014 safety statement, the Food and Drug Administration noted, “the FDA opposes the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.”
According to the FDA, it’s best to avoid laparoscopic power morcellation for these patients entirely since there’s no reliable way to tell whether a woman with fibroids has uterine sarcoma.
There are a variety of surgical alternatives available to women with symptomatic uterine fibroids that do not entail power morcellation.
Following up on its April 2014 warning, the FDA announced revised power morcellator recommendations in November 2014, advising clinicians to avoid using them in hysterectomies or myomectomies “in the great majority of women.” The FDA also advised that device makers include warnings on product labels concerning the potential of power morcellators spreading malignant tissue.
Patients argue in lawsuits filed against device makers that they were never advised that a power morcellator might spread and aggravate undiscovered cancer, and that if they had known, they would have chosen a different surgical treatment.
Manufacturers of Power Morcellators
Laparoscopic power morcellators are available from the following medical equipment manufacturers:
- Endo (blue)
- Cook Urological, Inc. is a company that specializes in urology.
- Ethicon, Inc. is a company that makes medical devices (a Johnson & Johnson subsidiary)
- FemRx is a female hormone replacement therapy (J&J subsidiary)
- Karl Storz is a German film director and producer.
- Medical LiNA
- Lumenis, Ltd. is a company based in the United Kingdom.
- Olympus America Inc. is a subsidiary of Olympus Corporation.
- Richard Wolf GmbH is a company based in Germany.
Morcellator sales have been halted by J&J.
Johnson & Johnson, the firm with the greatest share of the morcellator market, halted sales of their power morcellators globally shortly after the FDA issued a morcellation warning in April 2014.
The Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator are among the J&J items affected by the problem.
Morcellation is being campaigned against by a physician couple.
After having uterine morcellation, Amy Reed, a Boston-based anesthesiologist, was diagnosed with Stage 4 sarcoma. Reed and her physician husband, Dr. Hooman Noorchashm, started a campaign against morcellation to stop the procedure from being used.
Reed and Noorchashm claim that:
- After an unintentional sarcoma morcellation, the average survival duration is just 24-36 months.
- Women with sarcoma who had their power morcellated are four times more likely to die of sarcoma than women who have not had their power morcellated.
J&J’s decision to halt morcellator sales, according to Dr. Noorchashm, did not go far enough. He also believes the FDA’s warning is insufficient.
Noorchashm questioned, “Why are you leaving these gadgets on the shelves?” “We applaud the FDA for taking action, but they obviously have the ability to remove these devices from the market, which they haven’t done.”
Morcellators are now approved by the FDA under a contentious program.
The FDA’s 510(k) program permits new medical devices to be approved for sale without having to be tested on humans first.
The guidelines for Johnson & Johnson’s morcellation devices have long cautioned about the possibility of malignant tissue spreading. Since its morcellators—and every other power morcellator on the market—never underwent clinical testing, it’s unclear how the company arrived at this conclusion.
The FDA’s 510(k) clearance procedure permits new medical devices to be allowed for sale without previously being tested on humans, as long as they are “substantially identical” to an already-approved item.
According to the Wall Street Journal, the FDA approved at least 10 morcellators from various firms under the 510(k) procedure during a two-decade span, including devices produced by J&J, Cook, LiNA Medical, and Olympus.
Only a big clinical investigation, according to Dr. William Maisel, head scientist for the FDA’s medical device unit, could have identified early indications of power morcellator cancer hazards.
In 1991, the FDA authorized the first laparoscopic power morcellator. Cook, the business seeking sales approval for the first power morcellator, claimed four distinct medical equipment as “essentially identical” predicate devices, including a manual morcellator and tissue-punching devices.
Following the approval of the Cook morcellator, which came with no clinical study findings, succeeding devices were authorized based on “substantial equivalence.” These devices were then used to justify the approval of other morcellators, and so on, with the ultimate consequence that none of the current power morcellators have been authorized on the basis of high-quality evidence of safety and effectiveness.
Morcellation’s cancer risks were not evaluated by the FDA until 2013.
The FBI is looking into J&J’s devices.
According to The New York Times, the FBI started examining what J&J knew about the cancer risks of power morcellators before removing them off the market in May 2015.
According to the New York Times, Dr. Robert W. Lamparter, a retired pathologist who was interrogated by the FBI, cautioned J&J in 2006 about the potential for morcellators to spread cancer unnoticed. The doctor called this a “legal fig leaf” and said, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.” J&J allegedly updated product instructions in response to the doctor’s concerns, but the doctor called this a “legal fig leaf” and said, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”
Lawsuits have been filed against J&J and other morcellator manufacturers.
Several makers of electric morcellators have been cited in lawsuits alleging that the devices spread cancer undetected and injured women. In addition to state court actions, J&J’s Ethicon unit—the most commonly mentioned manufacturer—is facing around 100 morcellator claims in federal courts.
According to reports, J&J is working fast to resolve the situations.
Watch This Video-
Morcellator is a surgical instrument that is used to cut or remove tissue. Morcellators are typically inserted through the skin and into the body cavity with the intention of removing a tumor, but can also be used for other purposes. The word “morcellator” comes from the Latin words “morcere”, meaning “to kill”, and “-lator”, meaning “agent”. Reference: morcellator use.
Frequently Asked Questions
What is a power morcellator?
A: A power morcellator is a type of surgical device used to cut and remove tissue by directing suction through the operating site. It may also be referred to as an aspiration device or vacuum-assisted dissection/disarticulation system, or simply the Morcel.
Are morcellators still being used?
A: Morcellators are still being used but the usage of them is in decline. They have been replaced by hysterectomy for women and vasectomy for men due to their higher success rates, cost-effectiveness, less chance of complications and also because they can be performed without general anesthesia which has a lower risk profile than surgery under general anesthesia.
Is morcellation safe?
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