Defective Medical Device Attorneys in Philadelphia

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Since the 1990s, morcellators have been used in over 50,000 fibroid-removal procedures and hysterectomies each year, and have helped countless gynecologists perform these procedures with minimal scaring and reduced recovery time. The instrument, known as a power morcellator, uses a tube-shaped blade to remove fibroids from the uterus-or in some cases, the entire uterus. Unfortunately for many women, this procedure also increases the risk of spreading an undetectable form of cancer known as uterine sarcoma.

Golomb & Honik, P.C. is currently investigating Morcellator cancer claims.
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What are Fibroids?

Symptomatic fibroids are the reason for about 40% of the 500,000 hysterectomies that are performed every year in the United States. Women who are suffering from fibroids can experience heavy bleeding, pelvic pain, and discomfort. It is estimated that 20-40% of women age 35 and older have uterine fibroids of a significant size.

One of the main ways to treat symptomatic fibroids is to remove them completely or perform a total hysterectomy. For the last several decades, a growing number of gynecologists used the morcellator to perform these procedures without having to subject patients to traditional, open surgery.

Morcellator & Uterine Cancer

In April 2014, the Food and Drug Administration advised doctors to stop using the morcellator to perform hysterectomies or fibroid removal on women, citing its potential to spread a deadly uterine cancer. It is estimated that one in 350 women undergoing these procedures actually has a undetectable cancer known as uterine sarcoma. When the morcellator is used, it can significantly worsen the cancer, and the odds of long-term survival.

Physicians are concerned that using this powerful device to cut into cancerous tissue raises the risk of those malignant cells spreading to other tissues and advancing to a more dangerous and life-threatening stage. Unfortunately, uterine sarcomas cannot be detected until they are removed-and they are often mistaken for fibroids.

The FDA urges physicians and other doctors to avoid using the morcellator and turn to traditional open surgeries, other forms of minimally invasive surgeries, and nonsurgical alternatives to treat fibroids. Some of these treatments can include vaginal hysterectomies, drug therapy, and even ultrasound treatment.

Manufacturers of Morcellators

One of the largest makers of power morcellators is Johnson & Johnson’s Ethicon subsidiary. The company said that it will review the product labeling, per the FDA’s request and plans for an advisory committee meeting regarding the discouraging news. At the end of April 2014, Johnson & Johnson suspended worldwide sales, distribution, and promotion of its laparoscopic power morcellators. Those devices that were suspended include:

  • Gynecare Morcellex Tissue Morcellator
  • Morcellex Sigma Tissue Morcellator System
  • Gynecare X-Tract Tissue Morcellator

Safety critics are calling for Johnson & Johnson to recall these products, not merely suspend the sales of them. Until these devices are pulled from the market, they are still a danger to be used on unsuspecting women, raising their risk of deadly cancer.

Medical Needs & Legal Help

Women who have already had hysterectomies or myomectomies (removal of fibroid tissue) are urged to consult with their physician and attend a routine follow-up. If you have persistent or recurrent symptoms, or if your post-surgery tests come back positive for cancer, it is important to seek medical care immediately, as your cancer could have worsened from morcellator use.

If you or someone you love has been diagnosed with uterine cancer or medical complications after fibroid removal, you may have cause to file a claim against the manufacturer of the morcellator device. It is imperative that you discuss your case with an experienced and skilled Philadelphia product liability attorney immediately.

National Defective Medical Device Lawyers

If you or someone you love has suffered health complications or if your cancer has spread aggressively after your physician used a morcellator during your hysterectomy, you may be able to file a lawsuit. Women who have been diagnosed with uterine sarcoma after undergoing a hysterectomy may be able to file a lawsuit against the product’s manufacturer. We would be happy to review your case for free. Fill out a complimentary case evaluation form to get started. To contact us immediately, call (215) 278-4449.