You’ve heard a lot lately about the risks involved with certain hysterectomy devices. Due to your painful fibroids, and your physician’s recommendation, you’ve decided to have your uterus removed. However, although your doctor ensures you that the procedure will be quick, easy, and relatively painless, you’re still not 100 percent confident.
You’ve discussed in detail the differences between invasive and non-invasive procedures, how he plans on extracting your uterus, and what tools he plans to use. Your doctor informed you that this type of procedure requires a device called a power morcellator, which basically breaks up your uterine tissue and sucks it through a small incision. Although it seems straight forward, what happens if something goes wrong?
You know the Food and Drug Administration (FDA) has their eye on these types of devices, so what can be done to ensure your safety?
Risk Management Recommendations
The FDA has recently published a report about the possible risk of power morcellators potentially spreading cancerous cells during hysterectomies. Their concern is that since there is currently no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the device could disperse cancerous tissue deeper into the patient’s abdomen and pelvis. Therefore, they highly recommend that these types of devices aren’t used in these types of procedures. They also recommend, for safety and risk awareness that:
Health Care Providers
- Are aware of the FDA’s concerns.
- Refrain from using morcellation in women with suspected or known uterine cancer.
- Carefully consider alternative treatment options for women with symptomatic uterine fibroids, instead of hysterectomies.
- Thoroughly discuss the benefits and risks of all treatments with patients.
- Inform patients that their fibroids may potentially contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
- Look into using specimen bags or other precautionary measures during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.
Patients (Before Surgery)
- Discuss the risks of the procedure beforehand.
- Ask your health care provider about all available options to treat your condition as well as their risks and benefits.
- If power morcellation will be performed during your procedure, ask your physician to explain why he or she believes it is the best treatment option for you.
Patients (After Surgery)
- Verify that your physician will or has tested the removed tissue for the presence of cancer.
- Schedule periodic appointments with your physician to ensure that nothing new has developed.
- If you have persistent or recurrent symptoms or questions, don’t be afraid to inform your doctor.
When the Unexpected Happens
If your physician highly recommends a hysterectomy, and ensures you that using a power morcellator is the best option for you, you’ll most likely take his word for it. But what happens when something goes wrong? What do you do if the FDA’s concerns come true? You can contact an experienced lawyer. We can help you file a claim and may be able to help you get the compensation you deserve for your ordeal. Call now and see how we can help you.
Make sure your family and friends are aware of the risks involved with uterine power morcellation procedures. Use your social media to share this page with them via Facebook, or tell them to contact us directly to discuss any potential questions or concerns they may have about a recent surgical tool accident. Remember, they may not know their risks. By clicking the above media icons, you can help them get the information they need before it’s too late.