22 results

• FDA Issues Final Guidance On Morcellators Linked To Deadly Cancer Risk

  December 30, 2020

  Irvin Jackson

  The FDA's final guidance on power morcellators calls for them to only be used on younger women not suspected of having cancer, and only with the use of an approved tissue containment system.

• FDA Issues New Guidelines, Safety Communication On Use Of Power Morcellators

  February 26, 2020

  Russell Maas

  The FDA has issued a new draft guidance on the use of power morcellators linked to the spread of undiagnosed cancers, indicating they should only be used with adequate containment systems and only on certain patient populations.

• Morcellator Use Tied To Increased Risk Of Death In Women With Uterine Sarcoma: Study

  September 30, 2019

  Irvin Jackson

  A new study finds that women with uterine sarcoma who undergo morcellation face a significantly higher risk of death.

• CDC Weighs New Guidelines For Gynecologists For Detecting Uterine Cancer

  May 11, 2018

  Irvin Jackson

  The CDC is considering a review of how gynecologists evaluate women for hidden uterine cancer and other sarcomas, which may result in new guidelines.

• Uterine Fibroid Drug Esmya May Be Linked To Liver Damage, EU Regulators Warn

  February 14, 2018

  Irvin Jackson

  European regulators are raising concerns that the uterine fibroid drug Esmya, awaiting approval in the U.S., may be linked to liver damage and liver failure risks.

• Top Drug Risks and Warnings Highlighted in 2017

  December 26, 2017

  Irvin Jackson

  This is the list of the top 10 drug warnings and side effects of 2017, including warnings about breast implant cancer risks, gadolinium contrast agents and other unexpected complications.

• Power Morcellator Uterine Cancer Risks Raised In FDA Review

  December 18, 2017

  Irvin Jackson

  The FDA reports that risks of contracting uterine cancer from power morcellation could be as high as 1-in-225, and also warns that cancer spread through morcellation appears to be more deadly than other forms of uterine cancer.

• Power Morcellator Cancer Problems Highlight FDA Post Marketing Surveillance Failures: JAMA Editorial

  July 3, 2017

  Irvin Jackson

  A new editorial say failures to more quickly identify and react to power morcellator cancer risk were in part due to a lack of a sound post-marketing surveillance system to ensure the safety and effectiveness of medical devices once they are on the market.

• Embolization May Be Effective Alternative Over Morcellation For Uterine Fibroid Removal

  March 15, 2017

  Irvin Jackson

  A long-ignored technique known as embolization may be an under-used means of uterine fibroid removal, according to a new study. which comes as the medical community abandons morcellation procedures due to cancer risks.

• Morcellator Cancer Deaths, Duodenoscope Infection Risks Spur FDA Meeting On Hospitals Reporting Medical Device Problems

  December 5, 2016

  Irvin Jackson

  A public workshop is being held today by the FDA to discuss improving reporting by hospitals on potentially dangerous medical devices after a number of incidents where hospitals knew devices had problems but failed to report them to the agency.