The Government Accountability Office will inspect the Food and Drug Administration’s hasty approval of power morcellators.
Despite the fact that power morcellators are associated with minimally invasive surgery, Congress holds these controversial medical devices accountable for hundreds of cancer-related deaths.
After a multitude of dangers linked to power morcellators, the federal government is finally paying attention.
The U.S. Government Accountability Office (GAO) has launched an internal investigation to evaluate the Food and Drug Administration’s approval of the widely used surgical instrument.
How Could Surgery Spread Cancer?
Power morcellators are often used to fibroids, also known as benign growths, in the uterus.
Image: Journal of Ultrasound in Medicine
Many are inclined to believe that minimally invasive surgeries are safe, but that’s not always the case. Laparoscopic power morcellation procedures, which provide relief from uterine fibroids through small incisions, have extremely dangerous long-term side effects.
The devices treat uterine fibroids through two different kinds of procedures. Hysterectomies involve removing the uterus while a myomectomy focuses on eliminating the actual fibroids. A myomectomy is preferred for women wanting to have children. Less frequently, the devices are also used for renal nephrectomy or splenectomies.
Fibroids are painful mounds of tissue that cause heavy menstrual bleeding, extended periods and radiating pain. Fibroids are very common and can be removed by a medical professional.
During the power morcellation removal process, pieces of tissue are often left behind. The remaining tissue spreads throughout the body, forming undetected tumors that develop into cancer.
Women who underwent these procedures are increasingly being diagnosed with uterine cancer, causing the medical community to speculate on the safety of the devices. Since then, multiple studies have linked power morcellation to occult uterine cancer.
The Long-Awaited Investigation
The GAO will be evaluating the FDA’s 510(k) approval process and the time it took to add a warning label to power morcellators.
Image: Facebook
The devices, which are meant to come with few risks, have been used by medical professionals since 1991. As regulators begin to evaluate the devices, the truth will finally be uncovered.
The FDA issued a warning in April 2014 urging doctors to discontinue the use of power morcellators in their practices. The warning came after a study that unveiled the true number of women who developed cancer from power morcellation surgeries.
The results proved that 1 in every 350 women who had fibroids removed were at risk for uterine cancer. After six months, the FDA finally included a warning on the product’s labeling.
The investigation, which includes two major parts, was deemed necessary by twelve members of Congress. These lawmakers are determined to find out why the FDA waited months to warn the public about the dangerous side effects of power morcellators.
In addition, the investigation will evaluate the 510(k) approval process that brought the devices into the market with little speculation. The accelerated process, which limits the need for extensive pre and post-approval safety testing, may be responsible for the lack of awareness about the cancer-causing side effects.
Legal Support For Injured Patients
Patients who developed cancer from power morcellation deserve justice.
Image: ABC News
Federal investigators are set to start looking into the devices, but the issue remains largely unresolved until new regulations are enacted. Patients who underwent uterine fibroid surgery because they weren’t informed of the risks deserve justice now.
If you or a loved one developed cancer from a procedure that used power morcellation techniques, you are not alone. You are entitled to health-related compensation for problems caused by power morcellation procedures.
Click here for a free case evaluation to learn more about legal rights and remedies.
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