At the request of members of Congress, the Governmental Accountability Office (GAO) will investigate why it took the U.S. Food and Drug Administration (FDA) 20 years to warn the public of the risks power morcellator pose. It will also investigate why the FDA fast-tracked the approval of these devices. Power morcellators are used in minimally invasive gynecological procedures such as fibroid removal and hysterectomy surgery. Unfortunately, for women who have undiagnosed uterine sarcoma cancer, use of this device can spread cancerous tissue throughout the abdomen and pelvis. Problems with power morcellators have been occurring for years, but the FDA only recently issued warnings.
Investigating the FDA’s Approval Process for Power Morcellators
The GAO will also be investigating why the FDA fast-tracked the approval of power morcellators. The FDA classifies medical devices under the following three categories:
- Low-risk products. Such as a tongue depressor, which requires little FDA oversight.
- Moderate-risk devices. These devices can receive FDA fast-track approval without the need for new safety testing if the manufacturer can show that it operates like a pre-existing device—even if they are being approved for new uses.
- High-risk devices. Such as implantable products, that are more highly scrutinized and require large-scale clinical testing and extensive medical board review.
The FDA approved the power morcellators as a middle-risk device. However, in April 2014, the FDA warned that these products could significantly reduce the patient’s chances of long-term survival and in November 2014, required manufacturers to include a black-box warning on the labeling of their morcellators. This is raising questions about why the FDA ever fast-tracked the product and why it took so long to issue any warnings.
Many insurance companies are now limiting coverage for procedures using these deadly products and one manufacturer—Johnson & Johnson’s Ethicon subsidiary—has pulled these devices from the market. Unfortunately, some companies continue to manufacture them and doctors and hospitals continue to utilize them without warning women of the serious cancer dangers they could face.
If you suspect your doctor utilized a power morcellator and caused your undetected cancer to spread, you may have a medical malpractice claim against the doctor and hospital. You may also have a products liability suit against the manufacturer. We urge you to contact an attorney immediately so you don’t miss the deadline to take action and protect your rights. Start an online chat with our experienced legal team to learn about your legal options.