Morcellator side effects include the spread of an aggressive form of cancer. You may be entitled to receive compensation for medical bills, lost income and pain and suffering, among other losses. Our firm is currently working with some of the more experienced Morcellator lawyers in the country, who are filing Morcellator lawsuits for these injuries. There are no legal fees until you receive a settlement or award. Please call us toll free or fill out an online contact form.
Massachusetts Couple Makes Push To Ban Morcellation
CBS Boston | Aired: Apr 25, 2014
What is a Morcellator?
A Morcellator is a surgical tool that divides and removes masses of tissue. These devices are used in laparoscopic surgeries. The device itself consists of a hollow cylinder, which penetrates the body. The mass of tissue to be removed is cut into fragments with the device’s sharp blades and pulled into the cylinder to allow for extraction.
What Are Morcellators Used For?
Approximately 500,000 women will have a hysterectomy every year in this country. Morcellators are commonly used in hysterectomies (uterus removal) and myomectomies (fibroid removal), which are both treatments for uterine fibroids. Morcellators have grown quickly in popularity with as many as 75,000 procedures performed using this device every year. Fibroids are growths that usually appear in women during their child bearing years, but can occur at any time. Depending on the situation women will either decide to have the fibroid itself removed or the uterus entirely.
Fibroids develop when a cell from the smooth muscular tissue of the uterus divides many times, eventually causing the formation of a firm mass. Fibroids can range in size, from being incredibly small and undetectable, to larger more bulky masses. Three out of four women will experience fibroids in their lifetime, and almost all will go unrecognized because there are hardly any symptoms, and they are almost always benign.
Symptoms of fibroids include:
- Heavy menstrual bleeding
- Prolonged menstrual periods
- Pelvic pressure or pain
- Frequent urination
- Difficulty emptying bladder
Why Are Morcellator Lawsuits Being Filed?
One reason Morcellator lawsuits are being filed is because recent data has been analyzed and found 1 in 350 women undergoing myomectomies or hysterectomies for fibroids, have a form of cancer previously unknown to them. This makes the removal of fibroids via morcellation extremely dangerous. Fragmented tissue may escape into the abdomen and pelvic cavity. Loose pieces of tissue may attach to other organs, resulting in severe complications such as pain and infection. However, this is not the worst case scenario, morcellation of unknown cancerous fibroids can cause cancer to aggressively spread to other areas in the abdomen and pelvic area. There is no way to determine if a fibroid is cancerous until after it is extracted. If the cancerous tissue was to spread during morcellation, it significantly reduces the patient’s long term survival rate.
The aggressive cancers could include:
- Uterine Cancer
- Uterine Sarcoma
- Leiomyosarcoma (LMS)
If you or a loved one has suffered from Morcellator side effects you should speak with a Morcellator lawyer to learn more information regarding your potential Morcellator lawsuit.
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Did The Morcellator’s Manufactures Know About The Risks?
F.B.I agents are investigating one of the largest manufacturers of the power morcellator, Johnson and Johnson, who allegedly knew about the cancer spreading risk associated with the device. The Wall Street Journal reported that the FBI interviewed Dr. Robert Lamparter, a former pathologist at Evangelical Community Hospital in Pennsylvania. Dr. Lamparter warned Johnson and Johnson about the risks eight years before they pulled the product off the market.
Dr. Lamparter contacted the company’s Ethicon division after he began noticing more morcellated specimens in his lab…He wrote that he was concerned about several issues, including the potential for an undetected cancer to be inadvertently spread by the surgical instrument… ‘If a morcellation is done, the patient’s survival is jeopardized,’ Dr. Lamparter wrote.”
Why Are Women Choosing Morcellators For Fibroid Removal?
This method of removal for uterine fibroids has an incredible appeal for surgeons, as well as patients. Many women who suffer with fibroids choose surgery using morcellation because the procedure is known to have many benefits associated with it, including:
- Shorter post operation recovery time
- A reduced risk of infection compared to traditional hysterectomy
- Smaller scars, related to the smaller incision
- Less overall blood loss
Overall this is simply a much less invasive approach in comparison to the more traditional methods of removing these masses, which makes it much more attractive. However, there are other existing surgical options for women suffering with uterine fibroids. An experienced Morcellator lawyer can answer all your questions about this device.
What Are Other Treatment Options For Uterine Fibroids?
Traditional surgical options for removal of uterine fibroids:
- Surgical hysterectomy which would be performed either vaginally or abdominally;
- Laparoscopic hysterectomy without the use of morcellation;
- A laparotomy using a smaller incision then used in a traditional hysterectomy, this is known as a “Mini-Laparotomy”.
- Treatment via the use of drug therapy.
- The most effective procedure that evidence shows yielded the best results and fewer complications was the vaginal hysterectomy.
If a patient chooses to undergo morcellation surgery, as opposed to any of the other options, they should be aware of all the potential risks and adverse side effects involved. Patients should also be aware the U.S. Food and Drug Administration (FDA) released a health advisory on April 17, 2014, discouraging the use of power Morcellators with hysterectomies and myomectomies. The FDA also makes recommendations for women in their safety communication:
- Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
- If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.
- If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.
Who Manufacturers Power Morcellators?
Johnson and Johnson is the primary manufacturer of Morcellator medical device. This company’s Ethicon division began selling Morcellators in 1998. After April 17, 2014, when the FDA released their health care advisory regarding the health risks associated with the use of power Morcellators during hysterectomies and myomectomies, Johnson and Johnson announced that they would be suspending the sale of Morcellators until there is a better understanding of the risks. Johnson and Johnson’s Morcellators go by the brand names; Gynecare Morcellex, Morcellex Signma, and Gynecare X-Tract. Even though Johnson and Johnson have stopped any further sales of these Morcellators, there has been no recall for the devices from Johnson and Johnson, or the FDA.
Besides Johnson and Johnson, there are other manufacturers marketing this machine:
- FemRx: Diva Morcellatoruteri
- Hologic: MyoSure
- Interlace Medical: Hysteroscopic Morcellator
- Karl Storz GmBH: Rotocut (G1 & G2), Steiner, Sawalhell Supercut Morcellator
- LiNA Medical: Xcise Cordless Laparoscopic Morcellator
- Nouvag: Morcellator TCM3000BL
- Morce-Power: 2306 Electronic Morcellator
- Olympus Corp.: Gyrus PKS PlasmaSORD
- Richard Wolf GmbH: Morce – Power 2306
- Smith and Nephew: Trueclear Hysteroscopic Morcellator
- Blue Endo: MOREsolution Tissue Morcellator
Was Clinical Testing Avoided During The FDA’s Approval Process?
Many patients will make the assumption that surgical devices and procedures must undergo extensive testing to receive government approval, but this is not always the case. Of course the government tests the devices they intend on releasing to confirm their effectiveness, but that is only when the device is deemed to be significantly different from others that have already received approval. Medical procedures and devices are simply not subject to as stringent of an approval process as drugs. This means that issues with the new devices may not be discovered until after hundreds or even thousands of uses.
The FDA utilized a process known as a 510(k) in the approval of the Morcellator laparoscopic medical device. This process simply allows for approval based on the fact that the product is substantially similar to one that has previously been approved and is on the market. The power Morcellator was similar enough to another machine which had already been approved and therefore, with minimal review, it passed the initial test. This means that there is an inherent lack of knowledge regarding the safety and effectiveness of the product, because it bypassed human clinical trials. After the FDA became more aware of the issues surrounding the device, they released advisory and safety warnings regarding the product, and their research continues.
Timeline of Morcellator Lawsuits and Events in 2014:
- April 17 – The FDA released a warning that the power Morcellator shouldn’t be used in hysterectomies or fibroid removal because of the alleged risk.
- April 30 – The largest manufacturer of this device, Johnson and Johnson, stops the sale of the Morcellator because the surgical tool could spread cancer.
- May 7 – A federal lawsuit was filed on behalf of a woman who died of cancer after having a hysterectomy via Morcellation.
- May 30 – The manufacturers are hit with approximately 6 Morcellator lawsuits. The women are alleging that they were never warned that the device could spread cancer. Some of the women said that they only later discovered the danger after doing their own research. Debra Grymkoski is a woman who researched Morcellation on her own, and believes this may have saved her life. Read about Debra’s story here.
- June 9 – The Obstetrics and Gynecology Devices panel announces that they will meet in July to discuss the safety of power Morcellators. The FDA will then review any of the findings of the panel as part of their safety review. The panel will discuss the safety of the device as well as its potential to spread cancer.
- June 17 – According to an article in The Wall Street Journal, an advisory panel will meet next month to consider banning the Morcellator entirely because of its alleged link to the spread of cancer. The panel will hear from gynecology groups who claim that the Morcellators are valuable tools, as well as critics of the device. The FDA will then consider whether they should ban the device, classify them as high risk, or take no action.
- July 11 – According to Associated Press an advisory panel to the FDA is going to consider banning Morcellators in hysterectomies because of the cancer risk. Over a dozen people including physicians, surviving family members, and women with cancer argued that the risk of cancer was too high.
- July 22 – JAMA (Journal of the American Medical Association) published a study that estimates 1 in 370 women who have a hysterectomy via Morcellation actually have an undiagnosed uterine cancer. These conclusions were based on data collected from nearly 250,000 women who had a hysterectomy between the years 2006 and 2012.
- August 6 – According to an article in ObGyn News an advisory panel to the FDA is recommending a requirement for informed consent and that patients receive stronger warnings about the risk associated with power Morcellation.
- September 24 – The Dr. Oz show discusses the dangers of the common fibroid surgery tool, and how it is connected to the spread of cancer. Watch the video here.
- September 25 – According to The Wall Street Journal some surgeons are still using the Morcellator during surgery, despite the FDA warnings.
In addition to that lawsuit, another was filed by a woman, Brenda Leuzzi, who was undergoing treatment for cancer after being treated with a Morcellator that was manufactured by Ethicon. Read Brenda’s story here.
Dr Oz also spoke with a victim affected by Morcellation surgery. Sarah elected for surgery to remove her uterus via Morcellation, she found out later that she had cancer and allegedly the Morcellation caused it to spread. “My life is very decreased, I am going to prematurely die of this cancer” – Sarah
FDA Releases Health Care Advisory:
The Food and Drug Administration issued a safety warning discouraging the use of power Morcellators during laparoscopic surgery to remove uterine fibroids. They warned doctors that they should use other forms of treatment for this medical condition. The primary concern of the FDA is that “continuing the use of these devices is adversely affecting the safety and well-being of patients.” There is too much unknown, and too high of a risk linked to power morcellation.
The FDA stated:
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.”
The FDA is strongly discouraging the use of this medical device while they continue to investigate the extent of the issue. In addition, many hospitals have also suspended the use of this device until further examination into the safety and effectiveness is completed.
Johnson And Johnson Make a Statement:
The Dr. Oz Show reached out to the massive manufacturing company, Johnson and Johnson, asking them:
Why did you remove your power morcellation devices from the market? Was the power morcellation device manufactured by Johnson & Johnson a risk to women who have received hysterectomies or myomectomies in the past using the devices? What is your position on its use and safety for women to remove fibroids in or on the uterus?”
Johnson and Johnson responded with a letter in regards to the devices manufacturer Ethicon, their subsidiary. The letter stated:
At Ethicon, our first priority is to our customers and patients. As an expansion of our April 2014 global commercial suspension, Ethicon recently decided to initiate a worldwide voluntary market withdrawal of all Ethicon morcellation devices that currently remain in the market. (Important Note: This is a voluntary product withdrawal (not a recall) under FDA regulations because it is not related to how the product performs. The product performs as intended.)” Read the remainder of the letter here.
Why Contact Us?
If you or a loved one has suffered an unfortunate complication you believe may be linked to power morcellation, you may be entitled to compensation for your injuries. It is very important to get in contact with an experienced Morcellator injury lawyer that can help you with your possible claim.
You should speak to Morcellator lawyer that is knowledgeable regarding these particular cases in order to receive legal help that you can trust. We are currently working with some of the more experienced Morcellator lawyers across the country and will be able to provide you with the help that you need.
Feel free to contact us at 1-800-992-6878 or fill out a contact form for a free legal consultation. There are no legal fees until you receive a settlement or award.