Because September is National Gynecological Cancer Awareness month, it is important to educate about power morcellation.
Recently, the FDA examined this common procedure in gynecology, revealing that the device can be linked to speeding up the growth of cancers in the uterus.
Because of this, the FDA deemed the minimally invasive power morcellator procedure hazardous. The medical community in the United States has received this notification, the alert spanning hospitals, the manufacturers of medical devices, groups advocating cancer awareness, and medical facilities. Without prompting, Johnson & Johnson asked their customers to stop using and return all power morcellators.
This cancer-linked tool, the power morcellator, is implemented across a spectrum of laparoscopic surgeries. It is tube-shaped with blades that rotate. The rotating blades slice through tissue to break it down into fragments.
Those fragments can then be suctioned out through a tiny incision in the abdomen. Primary procedures where the power morcellator plays a role are hysterectomies and myomectomies (uterus removal and uterine fibroid removal, respectively).
The reason that the power morcellator is being recalled and targeted for cancer risk is because the device can cut into existing cancer cells, and those cells are then spread throughout the pelvis and abdomen. Women who have undetected gynecological cancers, notably leiomyosarcoma (LMS), are the ones who have heightened risks when undergoing operations wherein the power morcellator is used.
In July, there was an FDA hearing to discuss use of the power morcellator. Risks, dangers, and the future of the device were all topics of conversation. The current ruling is that doctors should aim to find a treatment that does not require the power morcellator, leaving it as a last resort.
Those looking at hysterectomies or myomectomies in their future are encouraged by the FDA to consult with their doctors. For cases where a laparoscopic procedure is the only option, be sure to investigate whether or not a power morcellator will be used.
Women who have already undergone a procedure with a power morcellator should make extra efforts to follow up with their doctors. It is crucial that power morcellation patients monitor their healing, especially if they are presenting with any residual symptoms.
WHAT ARE POWER MORCELLATORS ?
Recently, the FDA examined this common procedure in gynecology, revealing that the device can be linked to speeding up the growth of cancers in the uterus.
Because of this, the FDA deemed the minimally invasive power morcellator procedure hazardous. The medical community in the United States has received this notification, the alert spanning hospitals, the manufacturers of medical devices, groups advocating cancer awareness, and medical facilities. Without prompting, Johnson & Johnson asked their customers to stop using and return all power morcellators.
This cancer-linked tool, the power morcellator, is implemented across a spectrum of laparoscopic surgeries. It is tube-shaped with blades that rotate. The rotating blades slice through tissue to break it down into fragments.
Those fragments can then be suctioned out through a tiny incision in the abdomen. Primary procedures where the power morcellator plays a role are hysterectomies and myomectomies (uterus removal and uterine fibroid removal, respectively).
The reason that the power morcellator is being recalled and targeted for cancer risk is because the device can cut into existing cancer cells, and those cells are then spread throughout the pelvis and abdomen. Women who have undetected gynecological cancers, notably leiomyosarcoma (LMS), are the ones who have heightened risks when undergoing operations wherein the power morcellator is used.
In July, there was an FDA hearing to discuss use of the power morcellator. Risks, dangers, and the future of the device were all topics of conversation. The current ruling is that doctors should aim to find a treatment that does not require the power morcellator, leaving it as a last resort.
Those looking at hysterectomies or myomectomies in their future are encouraged by the FDA to consult with their doctors. For cases where a laparoscopic procedure is the only option, be sure to investigate whether or not a power morcellator will be used.
Women who have already undergone a procedure with a power morcellator should make extra efforts to follow up with their doctors. It is crucial that power morcellation patients monitor their healing, especially if they are presenting with any residual symptoms.
WHAT ARE POWER MORCELLATORS ?
Power Morcellators are medical devices used during various laparoscopic surgeries, such as hysterectomies and myomectomies, that aggressively cut uterine tissue into small pieces. This permits the tissue to be removed through a small incision site, with the proposed benefits including shorter recovery periods, fewer complications, and less pain.
However, due to recent scrutiny and a rise in reports in the medical literature, the FDA issued a safety alert in April 2014 discouraging the use of these devices in uterine and fibroid removal procedures, as they may spread an undetected or unsuspected uterine sarcoma. In this safety alert the FDA also noted there is no reliable method for accurately detecting uterine sarcoma prior to hysterectomy or myomectomy.
In response to this FDA communication, Johnson & Johnson’s power morcellator manufacturing unit, Ethicon, suspended all worldwide sales and distribution of power morcellators and ordered a voluntary market withdrawal, affecting all Johnson & Johnson morcellator products, including its Gynecare Morcellex, Gynecare X-Tract, and Morcellex Sigma. (Refer to: http://www.recallcenter.com/power-morcellator/lawsuit/ )
Power Morcellator Risks and Side Effects
The inherent risk of power morcellation is the dissemination of the broken-up tissue. Benign tissue can become implanted on abdominal structures and organs, resulting in conditions such as fibroids, endometriosis, and adenomyosis, potentially requiring further surgery.
Furthermore, power morcellators can spread malignant tissue from an undiagnosed uterine cancer, including leiomyosarcoma, endometrial stromal sarcoma, carcinosarcoma, and endometrial adenocarcinoma, and significantly worsen a patient’s prognosis from treatable to deadly.
Allegations Against Power Morcellator Manufacturers
According to The Pittsburgh Business Times, Johnson & Johnson may have been aware of the serious risks associated with power morcellators well in advance of the FDA’s warning.
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Compensation in Power Morcellator Lawsuits
Plaintiffs in power morcellator lawsuits may be eligible to receive compensation for a variety of reasons including medical costs, lifestyle stress, wrongful death, and pain and suffering. (Refer to: http://www.recallcenter.com/power-morcellator/lawsuit/ )
For example, patients who develop advanced stage, metastatic cancer or parasitic fibroids after undergoing power morcellation may be able to recoup medical expenses, from doctor visits and diagnostic procedures to the cost of surgery and chemotherapy.
The physical and mental pain and suffering associated with necessary subsequent treatments and a worsened prognosis will have a significant impact on a patient’s quality of life and is further cause for compensation. As a deterrent to future negligence, women may also be entitled to punitive damages as a result of the failure of device manufacturers to properly and thoroughly warn about the risks of the procedures.
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