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Morcellator Lawsuit

Morcellator Lawsuit

Dozens of lawsuits have been filed by women who developed cancer after doctors used a morcellator during their hysterectomy. Morcellators cut up the uterus to make it easier to remove, but they can also spread malignant cells and worsen undiagnosed cancer. Many women allege that they were never warned about this risk.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting morcellator induced injury cases in all 50 states. If you or somebody you know was diagnosed with cancer after a hysterectomy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

UPDATE: Morcellator Use Drops Off Dramatically

August 23, 2016 — Only 2.8% of minimally-invasive hysterectomies used power morcellators in early 2015, compared with 13.5% in early 2013, according to a research letter published in JAMA. The rate of complications did not increase. Click here to read more.

Ethicon Settles Morcellator Lawsuits for $100K-$1 Million

March 30, 2016 — Ethicon has reportedly paid settlements in about 70 morcellator lawsuits for $100,000-$1 million each, according to the Wall Street Journal. Click here to read more.

Overview

About 500,000 American women have a hysterectomy (surgery to remove the uterus) every year. At least 40% of hysterectomies are used to treat uterine fibroids, which are non-cancerous growths on the uterus. Unfortunately, about 0.2% of fibroids are actually uterine sarcoma, an aggressive type of cancer that includes leiomyosarcoma.

Since the late 1990s, laparoscopic power morcellators have grown rapidly in popularity for hysterectomies, with about 55,000-75,000 procedures performed in the United States every year. Morcellators use blades to cut up tissues into smaller pieces that are easier to remove from the body.

List of Morcellators and Manufacturers

  • FemRx – Diva Morcellator
  • Hologic – MyoSure
  • Lumenis Inc. – VersaCut Morcellator
  • Ethicon Gynecare – X-Tract
  • Ethicon Gynecare – Morcellex Tissue Morcellator
  • Ethicon – Morcellex Sigma
  • Interlace Medical – Hysteroscopic Morcellator
  • Smith & Nephew – Trueclear Hysteroscopic Morcellator
  • Olympus – PlasmaSORD
  • Olympus – Gyrus PKS PlasmaSORD
  • Nouvag – Morcellator TCM3000BL
  • Blue Endo – MOREsolution Tissue Morcellator
  • LiNA Medical – Xcise Cordless Laparoscopic Morcellator
  • Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
  • Richard Wolf – Morce-Power 2306 Electronic Morcellator

What is the problem?

The problem is that morcellators often leave behind tiny pieces of tissue. If the pieces contain cancerous cells, morcellators can spread aggressive cancer throughout a woman’s abdomen and significantly increase her risk of death.

FDA Approves Tissue Containment Bags

In April 2016, more than two decades after the first power morcellators hit the market, the FDA approved the first surgical bag to contain tissues. The agency cautions that the bags have not been proven to reduce the risk of disseminating cancer. Other risks include infection, organ damage, and longer surgery. Click here to read more.

Types of Cancer Linked to Morcellators

What is the risk?

The FDA estimates that 1 in 350 women undergoing a hysterectomy or fibroid surgery actually has undiagnosed uterine cancer, and 1 in 500 has highly-aggressive leiomyosarcoma. This risk-estimate is backed up by a study published in JAMA, based on data from 233,000 women who had hysterectomies between 2006 and 2012.

In the general population, only 1 in 10,000 women has undiagnosed uterine cancer, which is why doctors thought the risk of using a power morcellator without a tissue-containment bag was low-risk. However, women who get hysterectomies are not the “general population.” Many of them have painful, bleeding, or large fibroids, which are also symptoms of cancer. Unfortunately, there is no way to reliably diagnose cancer until after the surgery.

FDA Safety Communication for Morcellators

In April 2014, the U.S. Food and Drug Administration (FDA) published a Safety Communication with explicit warnings against using morcellators for the “vast majority” of hysterectomies and fibroid surgeries (myomectomy). According to the warning:

“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

Ethicon Pulls All Power Morcellators Off the Market

J&J commanded over 75% of the market for power morcellators until halting global sales in April 2014, days after the FDA warning. J&J asked doctors to return all power morcellators, calling the move a “worldwide market withdrawal” but stopping short of issuing an official recall for the following devices:

  • Gynecare Morcellex
  • Morcellex Sigma
  • Gynecare X-Tract

FDA Adds “Black Box” Warning About Cancer Risk

In November 2014, the FDA required a “Black Box” warning against using power morcellators in gynecological surgery due to the risk of spreading cancer. The decision came just months after experts recommended informed consent and stronger warnings about the risk. However, the FDA stopped short of banning morcellators, despite pleas by more than a dozen people, including women with cancer, surviving family members, and physicians.

Doctor Warned J&J About Risk in 2006

The Pittsburgh Business Times reports that Dr. Robert Lamparter, a pathologist with 28 years of experience, warned Ethicon that thier morcellators could spread cancer in 2006, eight years before the products were pulled off the market.

Dr. Lamparter contacted J&J after a “near-miss” involving a woman who had a hysterectomy. Doctors originally intended to use a morcellator, but were forced to switch to open surgery. When her uterus was removed, they found cancer. In a letter to the company, Dr. Lamparter wrote:

“If this woman had had a morcellization, her tumor would have been seeded into the peritoneum. … In about 1/300 hysterectomies at our hospital, we discover an endometrial carcinoma that was unexpected at the time of surgery. … If a morcellation is done, the patient’s survival is jeopardized.”

Morcellator Lawsuits

Most of the lawsuits have been filed by women who were injured by morcellators made by Ethicon, including the Gynecare X-tract and Gynecare Morcellex. Lawsuits have also been filed against Olympus Corp., Lina Medical (Xcise), Gyrus ACMI, Richard Wolf, and Karl Storz.

Many of the victims were diagnosed with leiomyosarcoma, an aggressive type of uterine cancer, after morcellators were used during robot-assisted hysterectomies. In some cases, women only learned about the risk of cancer after doing their own research. They accuse device-makers of failing to warn about the risk of cancer.

FDA Studies Cancer Risks 18 Years After Morcellator Approval

Dr. Amy Reed, the leader of a campaign to ban power morcellators because they can spread cancer, has published a scathing critique of the FDA’s 510(k) approval process and failures of medical device safety legislation. The FDA did not study the cancer risks of morcellators until 18 years after the surgical tools were approved for gynecological surgery through the 510(k) loophole.

Congress and FBI Investigate

Congress is calling on the U.S. Government Accountability Office (GAO) to find out why it took the FDA decades to realize that power morcellators pose serious cancer-spreading risks for women undergoing hysterectomies. The F.B.I. is also investigating how much J&J knew about cancer-spreading hazards of its morcellator surgical tool before pulling them off the market last July. In January 2016, U.S. Representative Mike Fitzpatrick (R-Pa.) has also demanded answers from the FDA after Ethicon and three hospitals failed to report deaths linked to morcellators.

Insurers Drop Coverage

Despite FDA warnings against using morcellators in the “vast majority” of women, some surgeons continued to use them. However, the use of morcellators has continued to drop as the top health insurers drop coverage for the procedure including Aetna, Inc., HCA Holdings, and other insurers covering over 123 million people.

Morcellator Class Action Lawsuit

The first lawsuits have already been filed by women who developed cancer after they were treated with a morcellator. However, these cases are not part of a morcellator class action — they are individual lawsuits filed by women who hired their own attorney to personally represent their legal and financial interests.

Morcellator MDL Centralizes Lawsuits in Kansas

In October 2015, a panel of judges centralized all federal lawsuits involving morcellator-upstaged cancer in the U.S. District Court for Kansas (MDL No. 2652) under Judge Kathryn H. Vratil. In the fist month, dozens of lawsuits were transferred into the litigation. About 40 lawsuits have been filed into the MDL as of March 2016.

Do I have a Morcellator Lawsuit?

The Schmidt Firm, PLLC is currently accepting morcellator induced injury cases in all 50 states. If you or somebody you know was diagnosed with cancer after a hysterectomy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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