‘Black Box’ Warnings Regarding Laparoscopic Hysterectomy Morcellation Add Cancer Language

The United States Food and Drug Administration has announced an update in its warning regarding power morcellators.  That updated warning includes language that states that using these devices may lead to the spread of cancer cells in the body.  This announcement was not met with a positive reaction by many who wanted to see a power morcellator recall issued.  A link to the announcement can be found here.

However, the language added to the ‘black box’ warning is the clearest yet with regards to the potential link between the use of these devices and the spread of cancer inside of women’s bodies.  The hope is that this new warning will reach the eyes of consumers so that they can make an informed decision regarding whether or not to have a procedure done with this device.

What Are Power Morcellators?

Power morcellators are medical devices that have been used prominently in surgical procedures performed on women, most specifically hysterectomies and uterine fibroid removal.  Power morcellators were seen as innovations because they allow doctors to use what is basically a robotic arm to perform the surgeries with a laparoscopic approach.  This avoids the need to cut a large incision, reducing the risk of infection and the recovery time for patients on average.

What Is the Problem with Power Morcellators?

Unfortunately, studies have been done that indicate that the use of a power morcellator increases the risk that women will suffer from a spread of cancer inside of their bodies.  That’s because these devices cut what is to be removed from the patient’s body into very small pieces before removing them through the laparoscopic incision.  Many women have previously undetected cancerous cells present in these areas.  When tissue containing these cells is exposed to other parts of the body on the way out, they can spread into those areas.

What Is a Black Box Warning?

A ‘black box’ warning, as it’s commonly called, is a step that is often taken by the FDA in response to allegedly dangerous products or medications.  This is a warning that is supposed to appear clearly on the packaging of products or on the products themselves in some cases.  These warnings are meant to alert consumers of the potential dangers of using these products.

Are Power Morcellator Cancer Concerns Valid?

According to many who have studied this product line, this is a valid concern, and actions by some of the manufacturers would tend to support that notion.  None other than Johnson & Johnson, a giant in the field, has suspended the sale of these devices.  There have also been power morcellator cancer lawsuits filed in different jurisdictions in the United States.

What Do I Do If I’ve Suffered Because of Power Morcellators?

If you or someone you love has been harmed as a result of using this device, you need to contact the power morcellator cancer lawyers at Parilman & Associates today to schedule a free initial consultation.  You can either email the firm or call 800-800-DRUG.