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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.

Facts regarding uterine fibroids

Posted on Friday, January 15th, 2016 at 11:46 am by Williams Hart   

Uterine fibroids are non-cancerous, smooth muscle tumors that form on the wall of the uterus, and they usually develop after puberty, typically after age 30. While they are usually benign, there are risks of metastasis when a power morcellator is used in surgery to remove these fibroids.

The Center for Innovative Gyn Care listed the following facts regarding uterine fibroids:

  • The development of uterine fibroids in women is common, and approximately 80% of the female population has fibroids.
  • Uterine fibroids, also called leiomyomas, are not relative to the risk of uterine cancer.
  • The growth of uterine fibroids is generally unpredictable. It may be fast or slow or stay the same. They may grow significantly or shrink.
  • About 1 in 1000 women has the risk of leiomyosarcoma, a rare form of cancer.

While uterine fibroids are not dangerous, power morcellation (the breaking down of large tissue into small fragments) may spread these cells throughout the body and put the patient at risk of leiomyosarcoma.

If you think you have suffered from the side effects of a power morcellator, please discuss your case with our lawyers at Williams Hart. Call us today at (713) 352-7071.

Symptoms of Uterine Fibroids

Posted on Tuesday, January 12th, 2016 at 11:10 am by Williams Hart   

Non-cancerous, smooth muscle tumors that develop on the walls of the uterus are called uterine fibroids. Generally, uterine fibroids are harmless and are not associated with the risk of uterine cancer; however, there are cases where the use of a power morcellator in surgery spreads the fibroids throughout the body and creates the risk that these cells will metastasize into a rare cancer called leiomyosarcoma.

Here are the symptoms of uterine fibroids, according to Mayo Clinic:

  • Long menstrual periods (seven days or more)
  • Heavy menstruation
  • Pain and pressure on the pelvis
  • Frequent urination
  • Difficulty with urination or emptying the bladder
  • Painful sensation in the back and legs
  • Constipation

If you are experiencing these symptoms, you may want to speak to your doctor about whether or not you have uterine fibroids. The sooner you take action, the better your chance of treating the condition before additional complications occur.

If you have been diagnosed with leiomyosarcoma and you think it was caused by the controversial medical device known as a power morcellator, speak with our lawyers at Williams Hart today by calling our office at (713) 352-7071.

The Risks of Power Morcellators

Posted on Sunday, January 10th, 2016 at 1:16 pm by Williams Hart   

Approximately 1 out of 350 women estimated by the U.S. Food and Drug Administration is at risk for the metastasizing of a rare type of cancer called leiomyosarcoma during fibroid removal surgeries that use the medical device known as a power morcellator.

Not only do power morcellators result in leiomyosarcoma, but the spread of a benign tumor, leiomyoma, is also likely in laparoscopic hysterectomy procedures. Leiomyoma may not be cancerous, but when the morcellators scatter the cells during the procedure, they may develop into fibroid tissues around the abdomen and may eventually cause widespread pain.

Drug Dangers also listed the following as the other possible side effects of morcellators:

  • Soreness, bruising
  • Abscess, infection
  • Bleeding, oozing, and pain on the incision
  • Damage to surrounding organs
  • Abdominal and pelvic pain
  • Reoccurrence of fibroid

The FDA recently shocked medical communities when it released a warning about the use of power morcellators in surgeries due to the dangerous effects. Lawsuits began throughout the country alleging the device inflicted severe pain and even cause the deaths of some patients. If you have suffered as a result of a power morcellator, please contact our lawyers at Williams Hart to find out how we may be able to help you. Call our office now at (713) 352-7071.

Congressman asks FDA for criminal investigation on morcellator

Posted on Sunday, January 10th, 2016 at 12:41 pm by Williams Hart   

According to Pennsylvania news sources, 8th district congressman Michael Fitzpatrick wrote a letter to the U.S. Food and Drug Administration on December 18 regarding a potentially harmful medical device, the power morcellator. The congressman is asking the agency to launch a criminal investigation about the dangers of using the morcellator in laparoscopic or minimally invasive surgeries.

The morcellator birthed numerous lawsuits all over the country in which the plaintiffs, who are usually female, allege that the device accelerated and spread uterine cancer cells after being used in surgeries.

The letter addresses the misconduct of well-known hospitals such as Brigham and Women’s Hospital in Boston, the University of Rochester Medical Center in New York, and the biggest manufacturer of the device in question, Johnson & Johnson.

If you have suffered as a result of the use of these highly dangerous power morcellators, please do not hesitate to contact our lawyers at Williams Hart to discuss your situation and let us help you develop a strategy against negligent medical professionals, institutions, and manufacturers. Call us now at (713) 352-7071.

Power morcellators a threat in laparoscopic surgeries

Posted on Wednesday, December 30th, 2015 at 2:30 pm by Williams Hart   

In early 2014, an announcement by the U.S. Food and Drug Administration shocked medical communities after power morcellators were said to be a threat when used in certain surgeries. A power morcellator is an electric-powered medical device used to break down large tissues into smaller fragments so that they may be removed through small incisions. It is commonly used in the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy).

After many years of research, the FDA found that morcellators could spread concealed cancerous tissues to different parts of the body. There have been lawsuits in which women have developed leiomyosarcoma after the use of power morcellators in surgical procedures. The lawsuits also accuse manufacturers and medical professionals of not disclosing the side effects of the product.

If you have been affected by the use of power morcellator, please bring your case to our esteemed lawyers at Williams Hart for help in pursuing compensation for negligent pharmaceutical manufacturers. Call us now at (713) 352-7071.

The Epidemiology of Uterine Leiomyosarcoma

Posted on Tuesday, December 29th, 2015 at 7:58 am by Williams Hart   

According to the Sarcoma Foundation of America (SFA), uterine leiomyosarcoma (LMS) is a type of rare tumor, and only about six women out of a million are diagnosed in the United States every year. Most uterine LMS are diagnosed after a hysterectomy or myomectomy. While it is almost impossible to diagnose LMS before a surgery, an MRI paired with a blood test for serum lactic dehydrogenase (LDH) may result in an accurate diagnosis.

Uterine LMS is treated with surgery, and, according to statistics from the SFA, this treatment prevents the tumor from spreading beyond the uterus in 75% of the patients. Unfortunately, LMS is aggressive; there is only a 50% chance of survival within 5 years for people whose tumor is only in the uterus.

The use of power morcellators in surgeries allegedly metastasizes cancerous cells that become leiomyosarcoma. If you think you have suffered as a result of a power morcellator, speak with our lawyers at Williams Hart to begin building your product liability case. Call us today at (713) 352-7071.

Doctors ask FDA to reverse morcellator warning

Posted on Tuesday, December 15th, 2015 at 10:36 am by Williams Hart   

Newsweek has recently reported that a group of gynecologists, oncologists, and women’s health experts have challenged the U.S. Food and Drug Administration’s warning notice on the use of power morcellators in uterine fibroid removal.

The physicians claimed that prohibiting the use of the electromechanical morcellator will just precipitate the use of more invasive and riskier alternative procedures and will pose more risks to the patient. The doctors issued an open letter to the FDA challenging the officials to reverse their decision to stop the use of the morcellator.

Power morcellators spawned lawsuits in recent years alleging that the device spreads uterine fibroids during surgical procedures which eventually become cancerous. The lawsuits involve mostly women, stating that they were diagnosed with leiomyosarcoma, a rare form of female cancer, after the use of morcellators.

If you have been negatively affected by the use of a power morcellator during routine surgery, the attorneys at Williams Hart may be able to help you pursue compensation for your undue suffering. Call us today at (713) 352-7071 to discuss your case.

What you need to know about power morcellators

Posted on Friday, December 11th, 2015 at 8:15 am by Williams Hart   

In the recent years, power morcellators have cause alarm in the women’s health community due to its alleged side effect of potentially spreading cancerous cells and expediting growth. In a recent blog post, the Wall Street Journal listed five things that are important to know when considering these devices. Among the bullet points are the facts that

  1. There is no surefire way to detect whether a fibroid is cancerous before surgery
  2. Morcellators are not perfect — these tools do leave bits of tissue in the body
  3. While some doctors are beginning to implement the use of bags to help contain the fibroid tissue, many gynecologists do not feel this is necessary
  4. There are alternative surgeries available to women with fibroids that may also offer smaller incisions and minimally invasive operations

While some doctors feel that there are benefits to the use of this tool, others have made it clear that it could pose dangerous risks to some women. If you have suffered as a result of the use of a power morcellator in your gynecological surgery, call the attorneys at Williams Hart today at (713) 352-7071 to speak to a pharmaceutical product liability attorney and learn more about your legal options.

Understanding the role of morcellators in leiomyosarcoma

Posted on Monday, November 9th, 2015 at 8:25 am by Williams Hart   

Leiomyosarcoma is a type of cancer that forms from smooth muscle cells in the soft tissues, usually in the gastrointestinal tract or the uterus. When these cells develop in the muscular part of the uterus, it is referred to as uterine leiomyosarcoma. This type of cancer is most common in women who range in age from 40 to 60.

One thing that has been identified as a danger to women who are at risk of developing this cancer is the power morcellator. This tool uses a rotating blade to break up large portions of fibroid tissues into smaller fragments and then vacuum them away from the body. When morcellators are used on fibroids that contain cancer cells, the act of breaking them up can release those cells and allow them to scatter throughout the body. This often leads malignant cells to grow much more rapidly than they would have otherwise, expediting the growth of metastatic leiomyosarcoma in the body.

If you were diagnosed with uterine or metastatic leiomyosarcoma after a procedure involving a power morcellator, please do not hesitate to contact the attorneys at Williams Hart. We want to fight for you and your rights so that you can focus on your recovery. Call us now at (713) 352-7071 to learn more.

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