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Impact of FDA power morcellation warning

Posted on Monday, January 9th, 2017 at 5:27 pm by Williams Hart   

In 2014, the US Food and Drug Administration (FDA) issued a warning about the potential risks of using laparoscopic power morcellators in hysterectomies or myomectomies. Since the announcement, there was a decrease in the utilization of minimally invasive hysterectomies, based on a retrospective cohort study conducted by the faculty from the University of Michigan Department of Obstetrics and Gynecology.

In the review, the utilization of power morcellators has significantly decreased, but cases in which a practitioner still opts to use major surgical non-transfusion, complications have increased by 27 percent and occurrences of 30-day hospital re-admissions have increased by 25 percent. Although the cause of the shift in practice patterns has yet to be determined, the study suggests that it has something to do with the FDA announcement discouraging the use of the medical device.

If you or someone you know has developed an undetected cancer following a hysterectomy or myomectomy involving a power morcellator, you may be entitled to a financial compensation. Our lawyers at Williams Hart have worked closely with these lawsuits and can properly represent you in court. Get in touch with us at (713) 352-7071 to learn more about your legal options.

FDA identifies hospitals non-compliant with medical device reporting standards

Posted on Thursday, January 5th, 2017 at 12:49 pm by Williams Hart   

At least fifteen hospitals across the United States failed to comply with the medical device reporting requirements, according to the FDA.

The FDA issued a Form FDA 483 to some prominent hospitals, including Massachusetts General Hospital and New York Presbyterian Hospital, for not promptly reporting deaths and injuries related to medical devices pursuant to 21 CFR Part 803. Under the federal regulation, user facilities, such as hospitals and health centers, have only ten days to submit reports about deaths of patients and serious injuries linked to medical devices to its manufacturer and the FDA. The rule also states that a user facility should maintain a medical device event filing system, which can be inspected by FDA. Out of 17 hospitals, 15 medical centers reportedly demonstrated failures to comply with the federal rule following FDA nationwide inspections. The inspection was initiated last December 2015.

If you or your loved one has been physically injured due to an accident involving a power morcellator, you may be entitled to a monetary claim. Our lawyers at Williams Hart have the experience and skills to properly represent you in court. Get in touch with us at (888) 220-0640.

Three things you should know about morcellation

Posted on Wednesday, January 4th, 2017 at 4:36 pm by Williams Hart   

A power morcellator is an electronic surgical device that has been used by doctors to minimize how invasive several abdominal procedures can be. However, in 2014, the usage of the device was put under criticism following the announcement of the US Food and Drug Administration (FDA) against the device, citing evidence that morcellators could spread cancer cells throughout a patient’s body. Here are some things you need to know about the device:

  1. Morcellators had been introduced to the public 20 years ago – The US Government Accountability Office (GOA) is investigating the case to determine why FDA cleared morcellators for use despite its potential risks.
  2. Risks of using morcellators are often overlooked – A recent study in South Korea shows that morcellating tumors is more dangerous than removing them with more invasive measures, as this is more likely to spread cancer.
  3. Warning led to changes in surgeries – After the morcellator issue had been spilled into the public sphere, US gynecologists changed the way they perform hysterectomies, preferring other options with fewer complications.

If you have developed cancer following a procedure involving a power morcellator, we might be able to help you. Contact our lawyers from Williams Hart at (713) 352-7071.

FDA urges hospitals to report medical device issues

Posted on Sunday, December 4th, 2016 at 12:24 pm by Williams Hart   

The US Food and Drug Administration pushes hospitals to streamline their process of reporting problems related to medical devices.

After receiving reports about the potential risk of using hysterectomy surgery devices, the FDA is said to be enhancing the agency’s current reporting system by determining how a medical device causes deaths or injuries. They are also looking at the possibility of forcing all hospitals to submit death and injury reports related to the issue.

The FDA is currently targeting laparoscopic morcellators following the death of a 51-year-old woman who died from uterine cancer. According to reports, the Brigham and Women’s Hospital did not report a case in which a power morcellator reportedly triggered the proliferation of cancer cells in the patient’s body. Meanwhile, the U.S. Government Accountability Office is currently conducting an investigation and will be releasing a report in January.

If you or someone you know has developed cancer after undergoing a surgery involving a power morcellator, get in touch with a lawyer from Williams Hart at (713) 352-7071.

Are Power Morcellators Still Relevant in Surgery?

Posted on Tuesday, November 15th, 2016 at 4:54 pm by Williams Hart   

Though the list of side effects in regards to the use of power morcellators tends to grow more and more frightening the longer you look at it, many people claim that the chances of such effects are incredibly low and the question about whether people should use morcellation during surgery lingers.

In the case of Amy Reed, a doctor and opponent to the use of the instrument, had personally undergone uterine fibroid removal three years ago. After her surgery, a rare cancer appeared in her uterine wall and she has since undergone four separate surgeries to remove the subsequent tumors.

Furthermore, the FDA has released a public warning against the use of power morcellators, claiming that they spread the same rare cancer that Reed has faced. The use of the tool has decreased from 13.5% of surgeries calling for them to 2.8%. The number of complications in hysterectomy surgeries has since remained about the same, but the spread of cancer has decreased.

Johnson & Johnson, the largest distributor of the tool, did issue a recall fo their devices, but since it was voluntary, the residual effects have not totally bumped the tool from use. There are several active lawsuits that directly address the morcellator misuse, proving that most people understand that the danger is real.

If you developed previously undetected cancer in the uterine wall following morcellator use, or some other side effect in direct conjunction with the tool, contact one of our attorneys of Williams Hart today. Call us at (713) 352-7071 to learn more information.

What is Laparoscopic Hysterectomy?

Posted on Tuesday, October 18th, 2016 at 3:21 pm by Williams Hart   

Some of the most common tumors found in the uterus are known as fibroids. Many people faced with needing surgery to remove these tumors are now opting for minimally invasive surgery as opposed to traditional, open surgery, though there is a risk factor.

Hysterectomies, or removals of the uterus, have been performed by gynecologists or obstetricians since 1843. The process was then revolutionized in 1989 when the first laparoscopic hysterectomy was performed.

Open hysterectomies are done through either a large cut in the abdomen or in the vagina, known as an abdominal hysterectomy or a vaginal hysterectomy, respectfully. In laparoscopic hysterectomy, only a small cut is made in the patient’s abdomen to insert a lighted camera called a laparoscope and robotic surgical arms. The result is less pain and a shorter healing time. However, one of the laparoscopic tools, a power morcellator, increase the potential risks of spreading cancerous tissues inside patient’s belly cavity.

The two main types of laparoscopic hysterectomies are total and partial. In a partial laparoscopic hysterectomy, surgeons remove the uterus only. Total laparoscopic hysterectomy involves the removal of both uterus and cervix or the lower part of the uterus that connects to the vagina.

Researchers have highlighted the real danger linked to power morcellators and their risk of spreading undetected cancer. If you underwent a hysterectomy in which your doctor used a morcellator and you experienced adverse effects, contact a Williams Hart attorney at (713) 352-7071 today.

Power Morcellators Demystified

Posted on Saturday, October 15th, 2016 at 4:03 pm by Williams Hart   

Power morcellators have been the subject of many discussions, both medical and scientific, for several years. However, many people are unsure what exactly morcellators are, how they work, and why they could be dangerous.

Q: What is the basic use of a power morcellator?

A: Power morcellators are small enough to be held and are comprised of a long, hollow cylinder and sharp edges. These sharp jaws are used to remove uterine fibroids and the cylinder suctions out the tissue.

Q: What exactly are Uterine Fibroids?

A: Uterine fibroids are an often noncancerous growth on the muscle tissue of a uterus, sometimes known to host undetected cancerous cells.

Q: What are the two types of fibroid removal?

A: Someone receiving a myomectomy will have the fibroids removed one at a time, while someone receiving a hysterectomy is having all or part of their uterus removed.

Q: What is the potential danger associated with Morcellators nowadays?

A: If the person having fibroid removal via morcellator has undetected cancer, the morcellator will spread the cancer cells around the abdomen, promoting the growth of further cancerous cells.

In surgeries to remove fibroids before the invention of morcellators, doctors would’ve had to make an incision that ranged from three to seven inches and required longer recovery time. In these cases, the fibroids or uterus were removed intact and the spread of cancer was significantly lowered because the fibroids weren’t opened.

Despite the fact that morcellators have been in recall for the past two years, many people still use them. If you’ve experienced new or aggravated forms of uterine cancer following a myomectomy or hysterectomy with a morcellator, you may have a legal option in receiving compensation. Contact an attorney with Williams Hart at (713) 352-7071 for more information.

Lawsuits against Power Morcellator Manufacturers

Posted on Wednesday, September 28th, 2016 at 2:52 pm by Williams Hart   

Although proponents for morcellators argue that they are overall beneficial to the medical community, several reports of women developing uterine cancers cannot be ignored.

The Food and Drug Administration (FDA) has issued no involuntary recalls on the item but they have released reports and warnings in relation to the suspected harmful effects of morcellator use. Though Johnson & Johnson subsidiary Ethicon issued a recall of the item, it was voluntary and some of their morcellators have a high possibility of still being in use.

Multiple lawsuits have been brought up against the pharmaceutical giant in regards to their morcellators:

  • In Pennsylvania on March 2014, a man filed his suit in memory of his 53-year-old wife, who had died a mere year after her hysterectomy done with a power morcellator. She had developed uterine cancer.
  • In New York, a woman diagnosed with occult uterine leiomyosarcoma, which dramatically shortened her projected lifespan, filed a suit claiming she had developed cancer following a hysterectomy in which a power morcellator was used.
  • In Florida, another hysterectomy patient experienced the spread of endometrial stromal sarcoma, which she had previously been unaware of.

The claims all include accusations that the companies failed to create safe devices and knew of these shortcomings and released them to the public with little warning anyway.

If your cancer has spread due to morcellator use, learn more about how you can alleviate financial burdens through legal means. Speak with morcellator attorneys of Williams Hart, by calling (713) 352-7071.

Use of Power Mocellator Drops after FDA Advisory

Posted on Thursday, September 1st, 2016 at 11:13 am by Williams Hart   

There is a significant decrease in the use of power morcellators after the U.S. Food and Drug Administration (FDA) issued warning that the tissue chopped by morcellators could contain cancerous cells and may spread throughout the abdominal cavity.

Since the FDA released its new guidelines, the rate of new minimally invasive hysterectomies using power morcellators has been declining. In 2013, 14 percent of minimally invasive hysterectomies were performed using morcellators. The number dropped to just three percent in 2015.

Despite the advisory, some doctors still support the use of morcellators. Women need to be aware of the risks that morcellation carries.

If you have undergone a medical procedure involving a power morcellator and have developed cancer in the process, speak with the Morcellator lawsuit lawyers at Williams Hart by calling (713) 352-7071 and learn how to assert your rights and to hold negligent parties responsible.

FDA Approves Container Bag For Power Morcellator Procedures

Posted on Monday, August 1st, 2016 at 2:37 pm by Williams Hart   

The PneumoLiner, a tissue container bag to be used in morcellator procedures, has been approved by the U.S. Food and Drug Administration (FDA). The device is comprised of a containment bag and tube-like plunger that delivers the device to the abdominal cavity. Removed tissue will be placed in the bag and sealed to prevent the spread of cancerous cells.

About 1 in 350 estimated women that undergo a hysterectomy or myomectomy due to fibroids may have undetected uterine cancer. The FDA still warns against the dangers of morcellators, but is allowing the use of the PneumoLiner when the uterine tissue is not suspected to be cancerous, only for women without uterine fibroids being treated with a hysterectomy, and for some pre-menopausal women with fibroids who are still hoping to have children.

William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement, “We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.”

If you have faced complications from a morcellator treatment and are looking for legal options, contact the attorneys of Williams Hart at (800) 220-9341.

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