Senators Urge FDA To Get More Power Morcellators Pulled From The Market
September 20, 2014 | Category: Medical Devices | ShareMost Ft. Myers personal injury lawyers, like Randall Spivey, know that individuals sustain serious injuries or even die "as a result of unwittingly using defective medical products and devices, most of which are recommended or prescribed by their physicians and approved by the U.S. Food and Drug Administration (FDA)." Recently, some U.S. senators asked the FDA to reach out to the manufacturers of power morcellators in an effort to get them to take those devices off the market due to the risk of them spreading undetected uterine cancer in women.
Back in April of 2014, the FDA issued a statement that it was advising against the use of a procedure known as "laparoscopic power morcellation" surgery because of its ability to spread cancer throughout the body. According to the Administration, about 1 in every 350 women who had hysterectomies via the use of morcellators ended up with unsuspected cancerous tumors in their uterus. That said, the senators are looking for the FDA to take a much tougher approach when it comes to use of the devices.
What Do the Senators Want Exactly?
According to WSJ, the letter asks the FDA to "request that other manufacturers of laparoscopic morcellation devices withdraw their equipment from the market until additional risk assessments and patient and clinical education can be performed." The senators also want the FDA to truly consider the testimony that was brought forth during the Administration's July hearings by families who had lost loved ones after they had surgery with a power morcellation device.
Ft. Myers personal injury lawyers who are familiar with the issues surrounding the devices are aware of the fact that back in July, Johnson and Johnson's Ethicon unit issued their own recall and contacted physicians to request that they return the morcellators. Still, this company is the only one that has taken any action with respect to withdrawing the devices. Other manufacturers, like Blue Endo, Olympus Corp, LiNA Medical, have yet to respond.
Cases Stemming From the Device
There have been a number of lawsuits filed with respect to power morcellators, some of which have claimed that the devices which are also used to take out uterine fibroids through a small cut in the stomach could spread undetected cancer cells throughout the body because it is fairly difficult for doctors to differentiate between cancerous tumors and benign fibroids (or sarcomas).
Medical literature and studies have long shown the increased cancer risks that is associated with morcellators since their approval, and even the FDA's own database has thousands of reports on file that go as far back as the 1990s with respect to power morcellators. In fact, new research has revealed that even more types of cancer than initially thought can be spread by the devices.
If you or someone you love has questions or concerns about power morcellators, or if you or a loved one has cancer or some other injury that you believe was caused by a procedure in which a power morcellator was used, contact the Ft. Myers personal injury lawyers at the Spivey Law Firm, Personal Injury Attorneys, P.A. right away.