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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.


Ovarian cancer patients taking beta-blockers have better survival rates

Posted on Tuesday, September 22nd, 2015 at 4:44 pm by Williams Hart   

A retrospective study found that ovarian cancer patients who took certain types of drugs for hypertension had better survival rates than other women with the disease, an article from WebMD reported.

In a study of 1,425 cancer patients taking beta-blockers, scientists learned that women taking beta-2 and beta-3 blockers, or nonselective beta-blockers, lived for almost eight years on average after an ovarian cancer diagnosis, as compared to three years among those who did not take beta-blockers. According to research, beta-blockers are known to inhibit the effects of epinephrine, which promotes the growth of cancer cells.

However, a researcher at the U.S. National Cancer Institute, Dr. Christina Annuziata, warned ovarian cancer patients about the dangers of using beta-blockers when you don’t have high blood pressure.

The use of power morcellators during hysterectomies may spread undetected cancer tissues in the inside lining of the uterus, resulting in ovarian cancer. To know more about holding the device makers accountable for all of your damages, seek the legal guidance and representation of our legal team at Williams Hart. Call us at (800) 220-9341 for a free case assessment today.


FDA under probe over power morcellators’ cancer risk

Posted on Tuesday, August 25th, 2015 at 4:52 pm by Williams Hart   

Twelve lawmakers have asked a government watchdog agency to inquire further as to why the U.S. Food and Drug Administration (FDA) took a long time to warn about power morcellators’ risk of spreading undetected uterine cancer, Medscape reported on Tuesday, August 11.

In a letter addressed to the U.S. Government Accountability Office (GAO), the members of Congress requested a study about the FDA’s delayed response over the medical device’s cancer risk. Lawmakers also asked the GAO to investigate whether the FDA’s current process of approving medical devices was enough to detect the dangers posed by the device.

In April 2014, the FDA advised surgeons to stop using power morcellators for uterine fibroid removal after learning that 1 in 350 women with benign uterine masses have undetected uterine cancer.

If your health has been compromised after undergoing a laparoscopic procedure involving a power morcellator, our team of power morcellator attorneys at Williams Hart might be able to help you secure the compensation you believe you deserve from the device manufacturer involved. Call us at (800) 220-9341 and tell us more about your situation.


Chemotherapy: A valuable uterine cancer treatment

Posted on Friday, August 7th, 2015 at 2:50 pm by Williams Hart   

Patients whose endometrial cancer has been diagnosed and treated early on have a better chance of survival and cure. In fact, diagnosing and treating earlier stages of endometrial cancer (stage 0 to stage 2) provide a 5-year survival rate of 69% to 90%. So, at the early stages at least, there are a majority of good outcomes for endometrial cancer patients.

One of the most effective treatment options for endometrial cancer is chemotherapy. Chemotherapy involves the use of a combination of drugs to fight against cancer. Because these cancer-fighting drugs reach throughout the body, chemotherapy is an effective treatment for endometrial cancer that has already spread beyond the uterus and the pelvic area.

Hysterectomies utilizing power morcellators have been found to increase the risk of spreading undetected uterine cancer. If you have been harmed by this device, you might be eligible to file a claim against the manufacturer of this product. To learn more about seeking compensation, consult with our power morcellator legal team at Williams Hart by calling (800) 220-9341 today.

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