The uterus is an amazing and complex part of the female body that not only can grow life but also nurture and protect life as well. Unfortunately, it is also the root cause of many women’s suffering. Ailments of the uterus—polyps, cysts, fibroids, and tumors—affect millions of women and cause excruciating pain. In many cases, the most effective form of treatment is surgical. Although precision removal of invading growths is an option, complete removal of the uterus is recommended for severe obstructions, cancer risks, and chronic pain.
The Centers for Disease Control (CDC) estimates that an average of 600,000 hysterectomies are performed each year, making them the second most common surgical procedure for women in the United States (cesareans being number one), Considering the frequency of this surgical practice—a reported 20 million women have undergone the procedure—you’d think there would be a perfected and standardized process for safe and efficient removal. Unfortunately, this isn’t the case.
An Advanced Tool Causes Advanced Problems
In April of 2014, the Food and Drug Administration (FDA) issued a report focusing on the risks associated with surgical devices known as laparoscopic power morcellators (LPMs). These devices are meant to be an alternative to invasive cutting during hysterectomies. They consist of rotating blades that are used to shred the uterus while still inside the patient. This tearing allows the surgeon to extract the tattered pieces through the cervix or through tiny incisions more easily than if he had to remove the entire uterus through the abdomen. Furthermore, since the morcellator functions internally, the patient would have less scarring and a decreased recovery time. However, the report from the FDA questioned whether the benefits of the tool outweighed the inherent risks—in particular for patients who required the surgery to eliminate cancer risks.
The report stated that although they weren’t being recalled, morcellators had been found to cause potential harm in patients and the majority of women undergoing myomectomies or hysterectomies for treatment of fibroids. The report further noted that the devices can cause cancerous uterine cells to be dispersed deeper into the patient’s abdomen, thus potentially spreading the cancer.
Although morcellators aren’t guaranteed always to cause harm (and in some cases may be more beneficial to the patient), the risk of injury is unpredictable and therefore dangerous. Therefore, the FDA recommended that manufacturers of these devices update their product labeling to warn about the risks of a “decrease [in] the long-term survival of patients.”
However, the report’s authors didn’t specifically recommend a recall.
Other Risks From Morcellators
Additional concerns associated with these devices include:
- Peritoneal (abdomen lining) damage. Hysterectomies with any tool require the surgeon to carefully and meticulously disconnect and remove the uterus from the pelvic and abdominal cavities. If the surgeon isn’t 100 percent steady, he can cause excess cuts, tears, and wounds in the abdomen that can easily become infected and cause a lot of pain. This risk is amplified when using a rotary cutter.
- Bowel perforation. If the bowel is accidentally punctured during morcellator surgery, fecal matter can leak into the abdominal cavity causing peritonitis and sepsis.
- Bladder tears. When the bladder is accidentally torn, urine can leak from the compromised bladder. Not only does this result in embarrassing episodes, but infections can quickly form as well.
Justifying an Injury Claim
Dozens of patients who were diagnosed with cancer after a procedure involving a power morcellator have since pursued lawsuits against physicians and morcellator manufacturers, citing the following causes of action:
- Negligence. An argument can be made that the makers of these devices breached the duty of care that they owed to the public by failing to adequately present the risks involved with use.
- Fraudulent misrepresentation. These complaints assert that the defendant companies knowingly misrepresented power morcellators as being safe and efficient when they knew they were not. Further, the claims assert that the misinformation not only put consumers at risk but was a deliberate tactic to increase profits.
- Failure to properly test. This claim declares that manufacturers placed the dangerous tool on the market without properly testing it for potential side effects or complications.
- Failure to recall. These claims argue that after the FDA report, the manufacturers should have stopped selling the devices due to the potential harm that could be caused. As a direct result of their failure to recall the devices or remove them from the market, more women were unduly harmed.
Weighing in on the Balance of Benefit vs. Harm
Given the potential risks involved, do you think it’s appropriate for surgeons to continue using morcellators during hysterectomies? Do you think the FDA should recall them, or are their benefits greater than their potential risks? Share your thoughts in our comment section. Your opinions and insights can help us understand our clients’ viewpoints. You can also show your support to those who are needlessly injured by liking this article on Facebook, or sharing it with your friends and family.
If you or a loved one suffered severe complications resulting from a power morcellation procedure, it’s important to act quickly to ensure that your legal rights are protected. We are here to help you pursue a claim for financial compensation. Although no one can give you back what you have lost, we can help you get the peace of mind to move forward. Contact us today for a consultation at 888-526-7616 and see how we can help you find peace.