The FDA has officially approved a new power morcellator – for an older type of plastic surgery known as “body contouring.” Despite the risks, surgeons have been using this device since 2009 to help with liposuction and abdominoplasty. The approval comes after intense lobbying from two medical societies that claimed it would aid in cosmetic surgeries by reducing surgical scarring. Critics say this is another example of corporate influence taking priority over patient safety, but some doctors argue that one or even two deaths would still be acceptable if they led to improvements in patient care.
The “fda morcellator recall” is a procedure that doctors use to remove tissue from the body. It has been approved by the FDA despite cancer risks.
The Food and Drug Administration (FDA) in the United States has authorized a novel surgical instrument used in minimally invasive gynecological operations, months after the agency prohibited its use due to cancer concerns.
Power morcellation has been found to spread cancer that was previously undiscovered in patients.
The Contained Tissue Extraction System, a form of laparoscopic power morcellator, was approved by the FDA through the controversial 510(k) protocol, which involves no human testing.
Olympus received clearance from the FDA on November 16 for the company’s next-generation laparoscopic PK Morcellator, even though Power morcellation has been found to spread cancer that was previously undiscovered in patients.
Morcellation with High Power Can Spread Cancerous Tissue
The removal of the uterus (hysterectomy) or uterine fibroids (laparoscopic power morcellation) is a surgical technique (myomectomy). A power morcellator–a device that looks like a portable drill–is introduced via a tiny incision during the treatment. The tissue is subsequently ground into little bits for removal.
Power morcellation hysterectomies and myomectomies have fewer problems than hysterectomies and myomectomies done via an abdominal incision.
But there’s a catch: power morcellation has been demonstrated to spread cancer (uterine sarcoma) in people who were previously undiagnosed. Hundreds of lawsuits have been brought by impacted patients as a result of this.
Uterine fibroids affect the majority of women at some time in their life. While most fibroids are benign, one in every 350 women has an undiagnosed uterine sarcoma hiding inside them. Power morcellation has the ability to spread malignant tissue outside of the uterus, lowering the patient’s long-term survival chances significantly.
The FDA advises against using power morcellation for hysterectomies.
The FDA issued a safety communication in April 2014 opposing the use of laparoscopic power morcellation for uterine fibroids or uterus excision.
“There is no reliable method to tell whether a uterine fibroid is malignant before it’s removed,” stated William Maisel, Chief Scientist. “Patients should be aware that the FDA discourages the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should talk to their doctors about the risks and advantages of the various treatment alternatives.”
The usage of power morcellation during hysterectomy and myomectomy has declined dramatically after the safety alert was released.
According to a report published in the Journal of the American Medical Association (JAMA), the number of women receiving power morcellation hysterectomy declined from 13.7 percent in the fourth quarter of 2013 to 2.8 percent in the first quarter of 2015. Following the FDA’s warning, a research presented at the American Society for Reproductive Medicine’s 2016 Scientific Congress indicated a 63.9 percent decrease in all myomectomies (including laparoscopic and abdominal).
Dr. Deirdre Lum told Medscape Medical News that “several of the current research analyzing the effect of the FDA warning against power morcellation have showed a decline in usage of power morcellation.”
The FDA’s warning, according to Dr. Lum, may have heightened concerns about tissue disturbance in general, leading patients and their physicians to seek out alternate fibroid treatment choices.
Olympus Morcellator Receives “Substantial Equivalence” Approval
The Olympus PK Morcellator is intended for the same procedures that the FDA has advised about. However, since the PK Morcellator has not been tested on humans, it is impossible to say if it presents a similar danger of cancer spreading.
Olympus’ morcellator was authorized by the FDA under the 510(k) procedure, which permits device manufactures to skip human testing if their new product is “substantially identical” to previously approved devices (so-called “predicate devices”).
The PK Morcellator and its predecessor have little design changes, according to FDA records. The PK and its predecessor, for example, share the same size, tissue dissection mode, and sterilization.
A “peeling” approach of tissue morcellation is new for the PK, as opposed to the “coring” morcellation technique utilized in the predicate. The PK is also compatible with the PneumoLiner containment sack, a “first of its type” device for containing morcellated tissue.
“The PneumoLiner device has not been proved to limit the spread of possibly malignant tissue during power morcellation,” according to the FDA.
The FDA approved PneumoLiner after a de novo categorization procedure. De novo categorization, although not the same as the 510(k) procedure, permits devices to avoid the far more stringent premarket clearance process.
Human testing was not conducted on the PK Morcellator or its containment bag.
According to a study published in The Journal of Minimally Invasive Gynecology, one out of every ten morcellation containment bags leaked and dispersed tissue.
Power morcellators have been called for to be taken off the market or, at the absolute least, designated as high-risk devices that would need premarket approval testing.
Johnson & Johnson’s Ethicon unit withdrew its morcellators from the market following the FDA’s warning. In March 2016, J&J settled the majority of the morcellator lawsuits it is facing for $100,000 to $1 million per case.
The “morcellated uterus” is a term that refers to the process of cutting up or dividing an organ into smaller pieces. The FDA has approved the new power morcellator despite cancer risks.
Frequently Asked Questions
Is power morcellation still used?
A: Unfortunately, no. The process of power morcellation has been banned from the United States in 2008 and is not allowed to be used on humans anymore.
Is MyoSure a power Morcellator?
A: MyoSure is not a power Morcellator, its just a hand held device.
What is power morcellation?
A: Morcellation is a surgical procedure that results in the removal of large fragments or blocks of tissue. In essence, it creates small pieces to facilitate easier digestion and absorption into blood vessels.
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