The Food and Drug Administration (FDA) does not regulate medical devices as stringently as they do prescription drugs. With a good amount of unregulated devices in the medical field, the risk of complications from the use of medical devices can therefore be high. Recently, the FBI began an investigation into a particular surgical device, the Morcellator. Invented by Johnson & Johnson, this laparoscopic power device has caused greater issues and further medical problems for patients than the company’s claims to have been aware of. In fact, the FBI is looking into the idea that Johnson & Johnson knew about the tool’s hazards before they pulled it off the market last year.
A morcellator is a surgical device used during procedures that treat uterine fibroids, such as hysterectomies or myomectomies. This laparoscopic device creates tiny, minimally invasive incisions, which allows the device’s rotating blades to enter the patient’s body and break down large tissue masses or tumors into smaller fragments. The broken down tissue fragments are then vacuumed out the body. However, the FDA says the morcellator may be responsible for seeding cancer into the patient. During the process of removing the small fragments of tissue mass, if any of the tissue containing cancer cells get left behind, they have the ability to spread to other part of the body, in turn leading to the development of tumors.
Prior to Johnson & Johnson removing their device from the market, surgeons had been using this device for procedures to treat uterine fibroids. The dangers of using the Morcellator were brought to light by Dr. Amy Reed, an anesthesiologist, and Sarah Robinson, a physician assistant. Both had this procedure performed, which resulted in worsening of their conditions. After Ms. Robinson’s cancer was worsened from the use of the morcellator, she collected a list of women and families of women whose cancer was worsened as a result of the device, which was sent to the FBI. Dr. Reed, along with her husband who is also a physician, have been vocal in a campaign to the FDA and FBI against the use of the morcellator. The FDA soon after recommended that laparoscopic morcellators no longer be used. Meanwhile, the FBI had started an investigation into whether Johnson & Johnson were previously aware of the devices link to the spread of uterine cancer in patients.