(866) 984-0113 call for your free personal
injury case consultation
Click for your free personal injury consultation
Click for your free personal injury consultation

New clinical trial set to determine safety of power morcellators

October 13, 2017

A woman who has uterine fibroids will usually visit a doctor to discuss what treatment options are available. In some cases, removing the fibroids is necessary. For a period of time, the use of power morcellators looked like a promising option for taking care of this issue. The device enabled the surgeon to preform minimally invasive surgery that had a faster healing time than traditionally surgery.

What some people didn’t realize at the time was that there was a sinister possibility hiding beneath the seemingly minor surgery using this medical device. It came to light that women who had fibroids removed using the power morcellator were at an increased risk of developing cancer. Ultimately, the use of this device to remove uterine fibroids was halted by most practitioners. A new trial might be bringing this option back, but some wonder if it will be safe.

The risk of the procedure

The power morcellator uses small blades to slice up the fibroid. This is what causes the danger. There is a chance that fibroids can contain cancerous cells, even if the woman isn’t showing any signs of cancer. When the fibroid is diced by the power morcellator, bits of it are dispersed inside patient. This can spread cancerous cells — something most women may not realize at the time.

If a doctor fails to do a biopsy on the fibroids or fails to alert a patient about the risk, a woman could go months without realizing their health has been compromised by a dangerous medical device and medical negligence. It’s only until after showing cancer symptoms that many women seek treatment and for many, by this time, it’s too late. Many women have died due to cancer that was spread by power morcellator fibroid removal.

A new clinical trial

The FDA approved the PK morcellator and PneumoLiner containment system last year. This set up the trial that is testing the suitability and safety of using the containment system, which is also known as an isolation bag, in fibroid removal. The isolation bag is meant to contain the bits of tissue that are flung about during the surgical procedure.

The new trail has been met with plenty of skepticism, but some people see hope in this method. A cardiac surgeon who lost his wife to cancer after a power morcellator procedure is shocked to know that the trial is even happening. He notes that there isn’t any evidence that this liner will stop the spread of cancer. He is concerned about what might happen years down the road to the women who use this new system.

Ultimately, each woman has to decide for herself what risks she is willing to take. The problem comes in when she isn’t told that the risks of a procedure are this serious. Lack of informed consent and other issues might lead to legal claims due to the nature of the problems arising from the use of certain medical equipment.