The health insurance industry is calling for stronger regulation over the approval of power morcellators, citing a regulatory loophole exposed last year when the device was found to spread undetected cancer cells during routine gynecologic procedures.
Free Power Morcellator Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and we can help.
What’s the Problem?
April 15, 2015 – The trade group America’s Health Insurance Plans sent a letter this week to Senator Bob Casey (D-PA) regarding how problems associated with laparoscopic power morcellators reveal weaknesses in how the devices are approved and monitored, according to the Wall Street Journal.
Casey wrote the group in part to gauge the insurance industry’s response to a Nov. 2014 FDA warning on morcellators, and to determine whether health plans track adverse events related to the devices. The agency warned that power morcellators shouldn’t be used on the vast majority of women undergoing hysterectomy and fibroid removal surgery.
Women requiring fibroid removal have a greater risk of developing uterine sarcoma than previously understood, the FDA said. The morcellator, which pulverizes and removes tissue through tiny incisions, could spread and worsen cancer, the agency said.
As a result of these problems, 3 of the 4 largest insurers have limited coverage for procedures involving power morcellators. Use of the devices has declined significantly since the FDA warning.
510(k) Approval Loophole
Nearly all medical devices are approved through a system called 510(k), which clears products deemed to be “substantially equivalent” to ones already on the market. In most cases, 510(k) doesn’t require clinical studies on humans to prove safety and effectiveness.
FDA approved the first laparoscopic power morcellator in 1991, and at least 10 more over the next two decades, via 510(k). Though reports indicate that the FDA was aware of problems with the devices soon after they first hit the market, the agency claims the magnitude of the risk wasn’t realized until much later.
Do I Have a Morcellator Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in laparoscopic power morcellator lawsuits. We are handling individual litigation nationwide and currently accepting new morcellation cancer cases in all 50 states.
Free Morcellator Lawsuit Evaluation: Again, if you or a loved one was diagnosed with cancer after undergoing surgery with a power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellation Cancer Suit and we can help.