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In April of 2014, the FDA issued a statement about the use of power morcellators as part of hysterectomy procedures that prompted Ethicon to issue a worldwide market withdrawal of its morcellator lines but the procedures themselves were allowed to continue. By November, the FDA went one step short of a total ban on morcellator use by warning doctors not to use them in hysterectomies and fibroid removal surgeries. The warning suggested that the devices should not be used in the vast majority of surgeries in women and morcellation should be the very last resort due to the associated health risks.

Timeline of Events

The latest statement by the FDA marks the latest in an eight year long series of events that led to the market withdrawal of power morcellators by Ethicon and the eventual warnings about their use. Ethicon parent company, Johnson and Johnson is currently under fire for failing to communicate the risks of morcellator use to doctors and patients after concerns were raised over eight years ago. The following is the progression of events that led to the latest statement from the FDA.

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Laparoscopic surgeries have become a popular option for numerous types of procedures due to their less invasive nature when compared with more traditional options. The need for power morcellator use during these procedures may place women at undue risk for serious complications and injury, however, which detracts greatly from the advertised benefits. Until recently, these risks were concealed from the general public and women elected to undergo procedures that involved power morcellator use without fully understanding the risks they posed to their general and long term health. If you must elect to undergo a hysterectomy, it is important to understand the alternatives in order to make an informed decision about your health.

Traditional Procedures

The FDA has recently concluded that while laparoscopic options are less invasive, that more traditional procedures may actually result in less damage to the urinary tract and require less time to perform. As a result, recovery times may actually be quicker following traditional procedures and the benefits of minimally invasive procedures may be exaggerated. There are three primary forms of hysterectomy that are performed without the use of power morcellators.

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The only surgery performed on women that is more common than hysterectomies is a cesarean section performed during childbirth. There are over 500,000 hysterectomies performed annually as a means to addressing numerous medical conditions and complications. It is often considered a last resort to treating cancer, fibroids, prolapse of the uterus, endometriosis, chronic pelvic pain and abnormal vaginal bleeding. Power morcellators have been used in some types of hysterectomy surgeries because they allow surgeons to operate on patients without the need for larger incisions. It has been found that the risks associated with morcellator usage may outweigh the benefits, however, and it is important for patients to be well informed of the risks and alternatives before undergoing these procedures.

Types of Hysterectomies

There are different types of hysterectomies that address specific needs and produce different outcomes. Depending on the condition, doctors may recommend one of the following forms of hysterectomy.

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Ethicon, the largest manufacturer of power morcellators issued a voluntary worldwide market withdrawal of its Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract product lines following a statement issued by the FDA discouraging morcellator use due to serious medical concerns in April of 2014. The Johnson and Johnson company refuses to call the withdrawal a recall and asserts that the devices work exactly as intended. The statement by the FDA sites concerns that include the spread of cancerous tissue and the formation of fibroids among other serious medical complications and conditions that have been found to result from morcellator use.

Uterine Sarcoma Concerns

Uterine sarcoma is a form of cancer that is difficult to screen prior to laparoscopic procedures. The use of power morcellators can spread malignant tissue and advance the course of multiple forms of uterine cancer, making treatment more difficult and rendering prognoses less optimistic. When the cancer is detected in stage one, there is a five year survival rate of almost two thirds of patients but the spread of malignant tissue through morcellator use can advance undiagnosed uterine cancers to stage three— which carries a survival rate of only fifteen percent. This is the primary concern cited in the FDA statement but not the only complication that may arise from power morcellator use.

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In April of 2014, the FDA released a statement that discourages the use of power morcellators during uterine and fibroid removal procedures after it was discovered that the devices could spread undetected uterine sarcoma and cause additional medical complications. Since the release of the statement, Ethicon has ceased the sale and distribution of its morcellators products and several insurance carriers opted to no longer offer coverage for procedures that involved their use. It is suspected, however, that Ethicon parent, Johnson and Johnson was aware of the risks associated with morcellator use eight years prior to the FDA’s statement.

Dangers Associated with Power Morcellators

Power morcellators are devices used during laparoscopic surgeries to cut tissue into pieces small enough to be removed through a small incision site. The procedures are advertised as being less invasive, less painful and requiring less recovery time. The use of a power morcellator disseminates both benign and malignant tissue, however, which can cause any of the following conditions and complications.

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Cancer scanThe recent recall of power morcellators used in gynecology has only heightened the controversy over the best procedures for treating uterine fibroids and performing hysterectomies. Morcellators are used in minimally invasive approaches for myomectomies and hysterectomies to decrease recovery time and reduce the chance of infection. However, studies indicate that morcellation produces significant negative consequences to the patient.

When the electric morcellation devices were first manufactured in the mid-1990s, they were considered a breakthrough in medical technology. Using a rotating blade, the narrow device can be easily inserted through a small incision to grind dense fibroid tumors into tiny fragments, before being suctioned out. As a result, many manufacturers joined the cause and brought their own versions of surgical morcellators to the medical marketplace. Some of these manufacturers include:

  • Johnson & Johnson
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Doctor talking to his female patientMany hospital networks in the United States have suspended minimally invasive uterine fibroids surgeries involving medical power morcellator devices, awaiting guidance from the FDA (Food & Drug Administration). The decision of hospitals to suspend uterine morcellator procedures is not surprising due to new evidence recently released.

In April 2014, the FDA issued a safe communication stating there is a direct connection of morcellator-involved myomectomies and hysterectomies with cancer. This connection poses a greater risk to women than initially believed. Recent studies claim that the number of cases involving previously undetected cancer spreading after a uterine fibroid procedure using morcellators is far greater than first reported.

Uterine Fibroids

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Global Settlement of Pending Stryker Rejuvenate and ABG II Lawsuits

A global settlement has been achieved in the pending Stryker Rejuvenate and ABG II Modular hip stem lawsuits pending in New Jersey state court and the sister case pending in the U.S. District Court for the District of Minnesota. The simultaneous announcement was made by Judges overseeing the matters on November 3, 2014.

Under the initial terms of the settlement, each plaintiff will receive $300,000 as compensation if they both had an implant of the recalled hip and had a revision surgery to remove the device on or before November 3, 2014.

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By the time that you have reached our site, you have likely visited many other attorney websites where lawyers hold out their expertise in the fields of hip defect litigation. Some of these are excellent attorneys– frankly, others have no more experience litigating medical device cases that handling an automobile accident. Experience plays a significant role in the outcome of most significant disability cases arising from defective medical devices. Our firm is one of a select group of law firms who is truly committed to seeing these cases resolved in the most favorable manner possible.

Our team has invested considerable resources into Stryker and DePuy cases already. We have consulted with some of the most respected physicians, surgeons, engineers, rehabilitation medicine experts, economists and life care planners all with the goal of presenting the most favorable case possible for you. If you are ready to speak with a team of professionals who will treat you with honestly and respect, contact our team now.

Attorneys at Rosenfeld Injury Lawyers have experience representing hip defect patients in a variety of circumstances and will take the necessary steps to provide for both your immediate and future care needs.

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If you are a recipient of a recalled Stryker hip product, you may wish to set an appointment with your orthopedic surgeon to determine what— if any medical intervention is necessary. In some cases, a revision hip procedure is not imminent, but may be something to consider in the future.

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