Suffered Complications from a Defective Surgical Device?
Power Morcellator Attorneys
What Is a Power Morcellation Devices?
Powers morcellators are surgical instruments that come with rotating blades for laparoscopic surgeries. This device allows surgeons to remove large masses of tissue during surgery by cutting it up into smaller pieces and extracting it through a port incision. The use of power morcellators allow for minimally invasive surgery, which leads to shorter recovery times, less pain, and a reduced risk of complications.
Power Morcellators & the Spread of Cancer
The use of morcellators has recently come under fire for the dangers they pose to women with sarcomas in the uterus. There has been recent medical evidence that shows the removal of the broken up tissue is not 100% effective; if any of the broken up tissue left within the body contains cancer cells, it can rapidly spread. Prior to undergoing a hysterectomy or myomectomy, women are screened for uterine cancer to minimize the risk of having cancerous cells spread. Unfortunately, cancer cannot always be reliably detected. In fact, there is a rare form of cancer that can mimic benign uterine fibroids, making it nearly impossible to detect prior to surgery. In most cases, the cancer is only diagnosed after the surgery when tissue is officially examined. The FDA notes that 1 out of 350 women who undergo a laparoscopic hysterectomy or myomectomy may have an undetected sarcoma. Since the cancer may not be detected, these women run the risk of having the aggressive cancer spread past the uterus if the tissue is left in the body. In fact, many women have had stage 4 cancer diagnosed after such a surgery, which may be linked to the morcellator.
FDA Warning: Discouraging the Use of Power Morcellation
On April 17, 2014, the FDA issued a safety communication regarding power morcellators and the dangers that they pose to women.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
The FDA noted that there are additional treatment options, including the following:
- Drug Therapy
- High-Intensity Focused Ultrasound
- Deliberate Blocking of Uterine Artery
- Laparoscopic Surgery Without Morcellation
- Laparotomy Using a Smaller Incision
- Traditional Surgical Hysterectomy & Myomectomy
The FDA went on to discourage healthcare providers from using power morcellation during surgeries for women who have uterine fibroids and to no longer use power morcellation for women who either have or suspect that they have uterine cancer. Patients should have all benefits and risks discussed with them; when / if it is determined to be the best option for women, patients should be informed that the procedure may spread undetected cancerous cells and that a specimen “bag” is being advocated to contain the uterine tissue.
FDA Calls for “Black Box” Warning
On Monday, November 24, the FDA released a warning against the use of laparoscopic power morcellators in both hysterectomy and myomectomy surgeries. The warning came after findings showed that the use of power morcellators in such procedures carried an increased risk to women with uterine fibroids. The warning came as an Immediately in Effect (IIE) guidance, where the FDA also called on manufacturers to include a “black box” warning on their product labels—something that is almost unheard of for medical devices.
The FDA urged manufacturers to include both a boxed warning and two contraindications on the device’s product label. The boxed warning would warn healthcare providers and patients about the risk of having a hysterectomy or myomectomy with the use of power morcellation as it could cause the spread of cancerous cells outside the uterus, thus decreasing the chances of long-term survival.
The contraindications would include stating that power morcellators should not be used if women are either peri- or post-menopausal or candidates for en bloc tissue removal; the other contraindication would state that the device should not be used in gynecologic surgery where there is tissue either known or suspected to be cancerous. While this is a step toward protecting women from this dangerous device, critics state that it is not enough and that the product should be subjected to a total ban to truly protect the health of consumers.
As one opponent of the morcellator said, “I think the wording is such that no sound practitioner would use it, but there are still people who won’t know who will be at the mercy of their physicians.”
The American College of Obstetricians and Gynecologists has since stated that they are pleased by the decision; however, they are seeking to obtain further clarification on the use of power morcellators on women who are eligible for the procedure. For example, some gynecologists have stated that the IIE guidance from the FDA would not likely have any effect on the way that they currently practice as they routinely work with women who are younger and therefore more prime candidates for use of the morcellator. Critics, however, point out that doctors would be taking a gamble with their patients—even with young women who have a comparatively lower risk.
Johnson & Johnson Stops Selling Morcellators
The Ethicon subsidiary of Johnson & Johnson has indicated that it will no longer be selling power morcellators following concerns about the use of the devices and the spread of undetected cancerous cells. The company, which has a commanding 75% control of the market, will not currently be recalling the devices; however, they will no longer be providing the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-Tract.
On July 30, 2014, Ethicon released a statement that said the following:
“We believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain. Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon Morcellation Devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk”
The worldwide suspension of these sales, however, does not stop professionals from using power morcellators that are already in their hospital. There are many who voice concerns that this is not a strong enough step and that Johnson & Johnson should be issuing a recall of this device.
Have Your Case Evaluated by Hurt In Mississauga Attorneys: 800.793.3903
At Hurt In Mississauga, we are committed to helping the victims of dangerous medical devices recover the just compensation they deserve. If you have been diagnosed with cancer after having a surgery performed with the use of power morcellation, we encourage you to contact us as soon as possible. We recognize the dangers that are associated with these devices, and we can help you fight to recover compensation for your losses.
To request a complimentary and confidential consultation, contact us today at 800.793.3903.
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