The FDA has approved about 2 dozen devices for laparoscopic power morecellation, which divides tissue into smaller pieces or fragments.
On April 17th, the FDA sent out an advisory that discouraged doctors from using laparoscopic power morcellators to remove fibroids because of a risk of worsening an often hidden cancer.
Following this action Johnson & Johnson suspended the sale of its power morcellators until their role in fibroid treatment is better understood and redefined by the medical community.
Johnson & Johnson Suspends Sale Of Power Morcellator Device
The company suspended sales of its device because of concerns over its potential to spread undetected cancer beyond the uterus.
Johnson & Johnson said that the step was not a product removal, as the FDA stated that power morcellation might be the best option for some patients.
Johnson and Johnson noted in a letter to customers that the instructions for its morcellation devices have always included precautions about the possible spread of malignant tissue.
Spokeswoman, Sheri Woodruff said “We are also reaching out to regulatory agencies around the globe as this is a global notification.”
Should The Devices Be Recalled?
Hooman Noorchashm MD, a cardiothoracic surgeon at Brigham and Women’s Hospital in Boston Massachusetts, told Medscape Medical news that Johnson & Johnson’s decision to suspend the use of these devices isn’t enough and the company should recall the products from the market.
Dr. Noorchashm’s wife, anesthesiologist Amy Reed MD underwent a hysterectomy using this device and developed leiomyosarcoma, tumors that develop in the smooth muscles of the body. After developing this cancer Dr. Noorchashm started a campaign against morcellation.
Dr. Noorchasgm believes that the FDA acted inadequately and said “… clearly they could pull these devices off the market, and they haven’t.”