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Inadvertent Injuries and Side Effects Caused by Morcellators

David W. Hodges
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Partner at Kennedy Hodges LLP practicing pharmacy error, medical malpractice and personal injury law
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You’ve explored every option but one, to no avail. You’ve taken medication, used heat and massage therapy, you even tried acupuncture—but nothing has helped your uterine pain. The one option left? Surgery.

After speaking to your doctor and double checking that there weren’t any other options, you agreed to set up an appointment for a hysterectomy. Knowing that you were hesitant about the procedure, he suggested using a device called a power morecellator. He assured you that this device would not only limit invasive cuts, recovery time, and external scarring, but it would also be faster and less complicated than normal surgery. Of course when put like that, you believed it to be a miracle. Less scarring, pain, and worry? There’s no question. You agreed on the spot that the non-invasive morcellation was what you wanted. However, once you got home and researched power morcellators, your excitement over the “miracle” device quickly turned to mortification.

You read several articles and reports about their dangers, as well as a few malpractice case studies dealing with the horrifying after-effects of their use. Now although your doctor assured you that it was safe, and that by using it you would feel much better than having invasive surgery, do the benefits outweigh the risks?

Common Morcellator Injury Claims

In April of 2014, the Food and Drug Administration (FDA) issued a report about surgical devices known as laparoscopic power morcellators (LPMs). This report stated that although they weren’t being recalled, morcellators had been found to cause potential harm to patients. They furthered their statement by suggesting that the devices, which use rotary blades to shred the uterus during hysterectomies for easier extraction, can cause cancerous uterine cells to be dispersed deeper into the patient’s abdomen, thus potentially spreading the cancer. As a result of these findings, the FDA recommended that hospitals stop using morcellators in non-invasive laparoscopic uterine surgeries.

On November 24, 2014, the FDA updated this warning to include that the danger is present “in the vast majority of women.” They also recommended that manufacturers of LPMs update their product labeling to warn about the risks of spreading cancer and the potential “decrease [in] the long-term survival of patients.”

However since this was only a recommendation, some healthcare providers are continuing to use them, while others, such as the Hospital Corporation of America Holdings Inc., are calling for an outright ban.

The ones who wish to ban the procedure do so with malpractice risks in mind. Those who choose to continue procedures with LPMs suffer the risk of being prosecuted for malpractice if the device happens to injure their patients. Although the FDA doesn’t believe that morcellators will always cause harm, and in some cases may be more beneficial to the patient, the risk of injury is unpredictable and therefore dangerous.

The most common issues associated with hysterectomy malpractice claims are:

  • Spreading of cancerous tissue.
  • Causing of 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 within the abdomen that can easily become infected, and cause a lot of pain. This risk is amplified when using a rotary cutter.
  • Ripping of the bowel. If the bowel is accidentally punctured without notice, fecal matter can leak into the abdominal cavity causing peritonitis and sepsis.
  • Tearing of the bladder. 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.

What Do You Think?

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. Show your support, we look forward to hearing from you.

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.

 

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