Amid Power Morcellator Controversy, Bernstein Liebhard LLP Notes Growing Questions Over FDA’s Expedited Device Approval Program

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Power morcellators first came to market decades ago, under the FDA’s 510(k) clearance program, which in most cases does not require controlled human testing.

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iven the tragic outcomes reported in regards to uterine morcellation in recent months, it’s not at all surprising that this program is once again under scrutiny.

As questions over the safety of power morcellator ( procedures continue to mount, Bernstein Liebhard LLP notes that the growing controversy has led to renewed concerns about the U.S. Food & Drug Administration’s (FDA) 510(k) clearance program. According to The Wall Street Journal, power morcellators were first brought to market decades ago under the program, which in most cases does not require device makers to conduct controlled human testing on a new product as long as they can demonstrate that its design is substantially equivalent to another previously-approved device. As such, the FDA never actually investigated the potential for morcellators to spread uterine cancers until multiple cases emerged this year of women whose undiagnosed malignancies were upstaged after they underwent uterine morcellation.*

“As the Journal points out, the FDA’s 510(k) program has been criticized in the past for allowing high-risk medical device to come to market without sufficient evidence that they are safe and effective. Given the tragic outcomes reported in regards to uterine morcellation in recent months, it’s not at all surprising that this program is once again under scrutiny,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancers following uterine morcellation.

Power Morcellators and Cancer
Power morcellators are used in laparoscopic hysterectomy and fibroid removal procedures to shred tissue so that it may be removed via a small abdominal incision. In a new morcellator cancer warning issued on November 24th, the FDA revealed that it had asked the manufacturers of power morcellators to add a black box warning – its most urgent safety notice – to their product labels. Among other things, the agency noted that the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or fibroid removal surgery is 1 in 352, while the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. There is no reliable way to screen for these malignancies prior to surgery, their spread via power morcellator can upstage the disease and greatly reduce a woman’s chance of long-term survival.

In its November 24th alert, the FDA also cautioned against using morcellators in women who are entering menopause, as well as those who have already been through menopause. The FDA also advised against such procedures for women who are good candidates for intact removal of the uterus, either through the vagina or via a procedure known as a mini-laparotomy. These recommended contraindications would apply to the vast majority of women who require a hysterectomy or fibroid removal surgery.

Women who allegedly experienced the spread of uterine sarcoma or other cancers due to a power morcellator may be able to take legal action against the manufacturer of the device. To learn more about the risks potentially associated with uterine morcellation, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call 800-511-5092.

*, The Wall Street Journal (via December 16, 2014

About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs’ Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.

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ATTORNEY ADVERTISING. © 2014 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

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Felecia L. Stern, Esq.
Bernstein Liebhard LLP

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