FDA Warns Against Laparoscopic Surgery Device

FDA Strengthens Its Warning Against Laparoscopic Device

According to reports, the FDA has issued an even stronger warning against the health risks posed by a once-popular device used in gynecological surgeries. The device, called a laparoscopic power morcellator, are used in performing hysterectomies or removing uterine fibroids.

The FDA has suggested that there are safety methods for conducting hysterectomies and removing fibroids. Common in older women, uterine fibroids do not have to be removed unless they are causing pain or bleeding. Laparoscopic power morcellators gained popularity because they offered a relatively easy way to remove fibroids or even the entire uterus through methods that were less invasive than previously used.

Laparoscopic Power Morcellators Linked to Cancer Risk

While the devices provided a less invasive approach to surgery, it has also been determined that the procedure to remove fibroids or the uterus through power morcellators can free cancer cells lurking in the uterus or fibroids, which can then spread to other parts of the abdomen and throughout the body.

While the FDA is unable to offer any exact statistics related to the link between cancer and power morcellators, it estimates that 1 in every 350 procedures involves previously benign tissue turning cancerous. Around 500,000 of these procedures are conducted every year.

Johnson & Johnson Issues Worldwide Uterine Device Recall

The top manufacturer of laparoscopic power morcellators in the US, Johnson & Johnson instructed surgeons to stop using its product in procedures back in April, and its subsidiary, Ethicon, has begun a voluntary worldwide recall of the product before it affects more women.

Experienced Product Recall Lawyers

If you or anyone you know has undergone a hysterectomy or fibroid removal, please contact one of our experienced personal injury attorneys immediately at 1-855-462-3330 or via email by clicking here.