The safety of medical devices is regulated by medical device makers and hospitals that use these devices self-reporting any deadly hazards to the public health experts of the FDA. However, not all hazards are self-reported.

A large number of women have allegedly been harmed after morcellators were used during surgery, without a doctor, hospital, or manufacturer self-reporting these incidences to the FDA.

Indeed, several major hospitals may have had knowledge of deadly complications linked with the use of morcellators, yet allegedly failed to reports these problems to the FDA.

U.S. Rep. Mike Fitzpatrick (R-PA) contacted the FDA’s Office of Criminal Investigations (OCI) to the apparent noncompliance of these hospitals. The FDA responded on March 29, 2016, saying that it had inspected the hospitals indicated in the letter. However, the OCI did not provide any of the results from this investigation.

This raises important concerns about the validity of self-reporting, especially when considering dangerous medical devices like power morcellators that can even be life-threatening.

Power Morcellators

According to reports and lawsuits, morcellation can spread potentially cancerous tissues throughout a person’s body.

Essentially, power morcellators are medical devices used by surgeons during hysterectomies and myomectomies to break up and remove uterine fibroids. Morcellators are like a small drill. A small incision is made during surgery, and the small blade of the device rotates rapidly in the incision to break up fibroid tissues.

Because of the very small incision involved in the procedure, morcellators are often considered less invasive than alternatives. However, using these devices might have serious side effects for women.

While power morcellators are supposed to cut up uterine fibroids for easier removal, this can put some women at risk of rapidly developing ovarian cancer, some complain.

If a woman’s uterus or uterine fibroids contain some form of cancer, unbeknownst to them prior to surgery with a morcellator device, use of a morcellator can spread tiny, cut-up pieces of cancer tissues throughout the body.

This can spread cancerous tissue further than it would have reached on its own, and allows the cancer to take over at a much more rapid rate.

According to the U.S. Food and Drug Administration (FDA), around 1 in 350 women who undergo surgery with a power morcellator may have undetected uterine cancer that can be spread elsewhere in the body during surgery. This can spread the growth of cancer, increasing the overall risk of cancer death.

Power Morcellation Lawsuits

A growing number of injured patients are filing lawsuits against medical device makers over power morcellators, alleging that the devices used during a hysterectomy or myomectomy ultimately spread the growth of cancer and increased their risk of fatality.

If you or someone you love has undergone power morcellator surgery and has since been diagnosed with ovarian cancer or another kind of cancer, you may be able to file a lawsuit.

Filing a lawsuit cannot take away the pain and suffering caused by power morcellation side effects, or bring a loved one back to life, but it can help to compensate for financial expenses incurred by medical bills and lost wages.