POWER MORCELLATORS - FIBROID TREATMENT - FDA CAUTIONS

[N'Zinga Shani]

HEALTH LITERACY – PREVENTION IS BETTER THAN CURE

• Capable patients / health care consumers should be actively involved in their own care.
• Ask questions; take notes; seek second opinions; know what you are being given or prescribed.
• Ask what are the intended outcomes; what are the benefits and risks?
• Keep notes of all the medications being taken; write down the dosages prescribed.
• Share that information with a trusted, reliable, family member or friend. It’s also best to take someone with you to your doctor visits, especially if you are dealing with new and challenging diagnoses.
• Write down the reactions you get to specific medications.
• Take nothing for granted. Empower yourself with good, reliable information. 
• Reach out to others; get the help and support you need to deal with health challenges.

Power Morcellators-- intended to shred fibroid tissue so it could be easily removed through a small incision-- is the latest medical alarm device.  The shredding ended up inadvertently spreading cancer that had not been detected.  Of course, this is more complicated than it sounds.  Bottom line is – get as much information as you can before agreeing to new procedures that can cause more harm than they prevent.

Power Morcellators – 888 – 998 -5308 – Find out about more recalls here

The FDA says surgical instruments called Power Morcellators may be responsible for seeding cancer in women who had hysterectomies or had uterine fibroids removed. In certain liver and spleen surgeries, the devices may spread cancerous tissue in both men and women.

http://www.drugwatch.com/morcellators/  (OneWorld does not endorse this site; it does have good information.  Visitors should not pay for informative from, or sign up with any of these sites) We strongly encourage visitors to get as much reliable information as is possible and to compare information from various sources.  OneWorld endeavors to find reliable sources and link those sources in our blogs.  We also lists government sources and national sources that we have found to be reliable and factual in the information they provide.  Visitors should only accept services/care from doctors whose offices they can make appointment with and go in and talk to face-to-face.  They should also ensure that treatment providers and facilities are certified by their state to provide the applicable treatment. 

FDA Intervention

In April 2014, the FDA issued a safety communication discouraging the use of laparoscopic power morcellators for the removal of the uterus and uterine fibroids. Based on an analysis of currently available data, it cited a risk of the spread of unsuspected cancerous tissue.

Uterine Sarcoma

The agency stated that analysis indicated that about one of every 350 women who undergo hysterectomy or myomectomy for uterine fibroids have uterine sarcoma, and there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma.

Sales Suspended

In response, Johnson & Johnson immediately suspended worldwide sales of its laparoscopic power morcellators. The FDA intends to convene a public meeting of the agency’s Obstetrics and Gynecological Medical Device Advisory Committee to discuss the possibility of further action.

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each. 1-888-INFO-FDA (1-888-463-6332)

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576...  Official FDA Site

Aetna to Stop Covering Routine Use of Power Morcellator (May 5, 2015) Power Morcellation Can Spread Hidden Cancer in Women, Regulators Say

http://www.wsj.com/articles/aetna-to-stop-covering-routine-use-of-p...

A news interview with 42 year old Dr. Amy Reed; she has been affected by Morcellator treatment.  Watch the interview linked below

http://www.cbsnews.com/news/doctor-with-cancer-morcellator-medical-...?

 www.oneworldpi.org/health OneWorld produces community health literacy information programs

   http://oneworldpi.org/blog/

[N'Zinga Shani]

POWER MORCELLATORS - FIBROID TREATMENT - FDA CAUTIONS
On May 5, 2015, Aetna announced it will to Stop Covering Routine Use of Power Morcellator. The Power Morcellation Can Spread Hidden Cancer in Women, Regulators Say. It is important that women become very informed before agreeing to treatments that offer questionable outcomes. We encourage you to read the complete blog on this topic. www.oneworldpi.org/