The FDA should move to put an end to the sale of morcellators and initiate an immediate recall on the items.
Philadelphia, PA (PRWEB) July 16, 2014
The law firm of Levy, Baldante, Finney, Rubenstein, Cohen & Chizmar, P.C. recognizes the deep-seated concerns shared by many in regard to laparoscopic power morcellator devices intended for use in various types of uterine surgeries, including hysterectomies and myomectomies, and on the heels of a Food and Drug Administration advisory panel meeting, it's asking the FDA to do the same. The hearings concerned a device currently being assessed for its propensity to spread uterine cancer to other portions of the body.
This past April, the FDA warned doctors against using these morcellator devices to conduct an operation, at the time requesting new labels that would delineate the potential risk to patients (FDA NEWS RELEASE, 4/17/14). Johnson & Johnson’s Ethicon unit subsequently halted the sale and distribution of the morcellators.
The FDA panel (NEJM Journal Watch, "FDA Advisers Call for Black-Box Warning or All-Out Ban on Morcellators in Fibroid Removal," 7/14/14) was intended to give the agency a clearer idea of the risks of the device and the best course of action. While the advisory panel failed to reach a consensus, there were signals from many participants that a future halt on usage might be in the offing, with the majority opinion that morcellators should be banned or at the very least limited. This insight came after a set of hearings in which doctors spoke on the matter and people affected by a surgery gone wrong shared their plight.
Levy Baldante Finney Baldante Rubenstein & Cohen is asking the FDA to follow the lead of those advisory panel members who recognized the inherent danger posed by these uterine surgery devices. They ask that the FDA ban the further sale and usage of morcellators for uterine surgery.
The New Jersey and Pennsylvania personal injury law firm’s medical device liability branch has taken an active interest in the subject and is working to assist people who have been negatively impacted by these products. Martin G. Rubenstein, the firm’s lead on Drug and Medical Device litigation, had this to say:
“Early word out of the morcellator advisory panel is encouraging,” said Mr. Rubenstein, “but in the past, I’ve seen various instances where the FDA’s final decision does not align with what concerned panel members have urged. It’s more important than ever that the FDA take a look at the facts and come to a wise decision regarding the usage of these devices.
“In order to offer the highest degree of protection to citizens, the FDA should move to put an end to the sale of morcellators and initiate an immediate recall on the items. At the very least, new usage guidelines must be put in place that prevent the products’ continued usage except in extreme cases where immediate medical intervention is necessary and a doctor has been able to rule out the presence of uterine sarcomas. In such instances, a patient must be made well aware of the potential dangers.”
“It’s my sincere hope that the FDA acts at once so that no one else has to be put at risk by these devices.”
The law firm of Levy, Baldante, Finney, Rubenstein, Cohen & Chizmar, P.C. has been fighting for the rights of injured parties since its founding in the 1960s. Recognized by such organizations as Super Lawyers, the American Association for Justice, and the Trial Lawyers Associations of both Pennsylvania and New Jersey, Levy Baldante is dedicated to assisting persons injured by medical malpractice, automobile accidents, defective products, premises liability, and other instances of personal injury. A host of personal injury resources and a free consultation are available via the firm’s Laparoscopic Power Morcellator Uterine Surgery Lawsuit webpage.