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FDA Issues Statement Discouraging the Use of Power Morcellators

FDA Issues Statement Discouraging the Use of Power Morcellators












New York, NY (PRWEB) September 15, 2014

What is a Power Morcellator?

The power morcellator is a device that is used to facilitate the removal of tissue by breaking it up, actually cutting it up into smaller pieces, so that can be more easily removed. The devices are used primarily in minimally invasive laparoscopic surgeries and have been extensively used to in performing hysterectomy (removal of the uterus) and myomectomy removal of fibroid tumors). The ability to perform such surgeries laparoscopically means a faster recovery time for patients with less risk of infection. Obese patients are especially at risk for complications when traditional surgical techniques are used. Laparoscopic surgery has been seen as a safer and less invasive alternative.

What are the dangers?

Recent evidence suggests that the use of power morcellators may disseminate cancerous tissue within the body. The FDA reviewed 18 studies of patients who underwent hysterectomy and myomectomy (removal of fibroids) between 1980 and 2011. According to the FDA:

“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.”

What is being done?

The FDA is discouraging the use of power morcellators during hysterectomy and myomectomy and recommending that the risks be thoroughly considered and discussed with patients prior to surgery. A meeting in July of experts at the FDA did not result in a clear ban of the devices however there has been an increase in Power Morcellator Lawsuits.

Despite the fact that the FDA has not issued an official ban on power morcellators, many hospitals and surgeons discontinued their use based on these reports and recommendations. Additionally, Johnson & Johnson, the largest manufacturer of these devices, has voluntarily halted sales of power morcellators according to the Washington Post on July 30, 2014.

Meanwhile, some surgeons are suggesting that the use of a bag to collect tissue that has been morcellated will minimize the risk of it being disseminated into the abdominal cavity, according to the American College of Obstetricians and Gynecologists May, 2014 special report. More thorough screening of patients to detect uterine sarcomas is also recommended. It is estimated that 1 in 352 women may have undetected uterine sarcomas. These women are at risk if they undergo laparoscopic removal of fibroids or hysterectomy.

Patients who are surgical candidates for hysterectomy or myomectomy, should discuss these risks with their doctor and explore their surgical options.

For more information about laparoscopic hysterectomy or myomectomy with power morcellation, and the remedies available through the legal system, contact the New York personal injury attorneys at Pulvers, Pulvers, Thompson & Friedman today.













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Early foetal development is the time when cardiovascular risk is first evident, leading to heart health issues later on in life, reveals Chemist Direct

Early foetal development is the time when cardiovascular risk is first evident, leading to heart health issues later on in life, reveals Chemist Direct











Heart health issues can be detected in early foetal development


London (PRWEB UK) 28 February 2014

Human foetal development is the most dramatic and reaches the highest rates of growth during the first trimester of pregnancy. In the third week after gestation the embryo begins the basic growth and development of the brain, spinal cord, heart and gastrointestinal tract, followed in the next few weeks by the development of the limbs and sensorial organs.

Because of the critical vulnerability of the developing cells during this time, expecting mothers must ensure that adequate amounts of nutrition and vitamins such as folic acid are consumed in order to prevent defects in any of the organs.

Developmental adaptations in these organs are also determined by the mother’s exposure to harmful substances in the environment which may also cause increased risks of chronic disease in early childhood or adulthood. By actively being aware of important aspects of heart health, both of the mothers and the foetus, the instances of increased heart disease later on in life can be minimized, according to evidence in a new study published by the British Medical Journal. http://bit.ly/1aCcW7P

In this study nearly 2,000 children born in the Dutch city of Rotterdam were followed from the 10th to 13th week of gestation to the age of six to track the health markers for cardiovascular disease risk. The amassing of central body fat, instances of high blood pressure, high insulin levels and high cholesterol, all indicators of health issues later on in life, were more prevalent in those who showed a low birth rate and slower development as a foetus in the first trimester scan.

“These results suggest that the first trimester of pregnancy may be a critical period for development of offspring cardiovascular risk factors in later life,” said Prof Vincent Jaddoe, who led the study team from Erasmus University Medical School. “Therefore adverse maternal lifestyle habits influencing early foetal growth may have persistent consequences for their offspring, many decades later.” http://bit.ly/1fvnrFs

In another study published in The Cell, http://bit.ly/1fmi7q0 US researcher Professor Tamas Horvath, from Yale School of Medicine, and co-author Dr Jens Bruning, from the Max Planck Institute for Neurological Research in Germany found that the diet of expecting mothers also played a role in effecting the long-term metabolic health of their children through developmental changes in the foetus during the final third trimester.

Mothers who suffered obesity during pregnancy passed on genetic coding that changed the neurological wiring of the foetus, substantially increasing the risk of developing long-term disorders such as diabetes, cardiovascular disease and uncontrolled central body fat.

Although scientists now understand the direct link between the mothers nutritional intake and health risks to the developing foetus and cardiovascular defects, further study is needed to understand why this pattern exists and what it might mean for preventing heart disease and other chronic illnesses such as diabetes.

When pregnant or if planning a family, speak to your GP or midwife about precautions to take or how to minimise pollutants such as smoke, so that development continues smoothly without passing on heart risks or any other health issues.























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Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.









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