44 results

• FDA Provides Guidance on Tissue Collection Systems For Power Morcellators

  June 23, 2022

  Russell Maas

  The FDA has issued a new draft guidance to direct medical device manufacturers on how to ensure power morcellator tissue containment systems are safe and will not put women at risk of the spread of uterine cancer cells.

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  The FDA has issued a new draft guidance on the use of power morcellators linked to the spread of undiagnosed cancers, indicating they should only be used with adequate containment systems and only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

• 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.

• 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 Risk Controversy Highlights Weak Reporting System: GAO

  February 15, 2017

  Irvin Jackson

  A GAO report indicates that the FDA's adverse reporting system and its voluntary nature may have delayed the agency from detecting heightened cancer risks linked to the use of power morcellators.

• New Olympus Morcellator Safer, But Not For Women With Suspected Cancer, Company Warns

  November 18, 2016

  Austin Kirk

  Olympus has received approval for a new morcellator equipped with a tissue containment bag, amid concerns that morcellators can spread cancerous cells throughout a woman's body.

• Declining Morcellator Use Has Not Led To Increased Hysterectomy Complications: Study

  August 24, 2016

  Irvin Jackson

  Researchers have seen no increase in hysterectomy complications as the medical community walks back from power morcellator use over cancer fears, according to a new study.

• Laparoscopic Morcellator Review Should Be Included in ‘Cancer Moonshot’ Lawmaker Says

  April 19, 2016

  Irvin Jackson

  A congressman is urging the administration to include a medical device review and monitoring process as part of the "Cancer Moonshot" initiative, specifically calling for a review of power morcellators and their links to cancer.