[Malden]

Malden kaže:

A sada nešto friško, od jučer:

http://www.fda.gov/MedicalDevices/Sa.../ucm303318.htm

U.S. Department of Health and Human Services
U.S. Food and Drug Administration (FDA)

Alerts and Notices (Medical Devices)

FDA Safety Communication:
Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

Date Issued: May 10, 2012

...

Some individuals, organizations and websites promote an experimental treatment of CCSVI that uses balloon angioplasty devices or stents to widen the narrowed internal jugular or azygos veins. This procedure is sometimes called "liberation therapy" or the "liberation procedure".

...

Dio koji daje preporuku MS-pacijentima:

Recommendations:

For People with Multiple Sclerosis:

• Be aware that there is lack of clear evidence of the existence of CCSVI. Furthermore, the link between CCSVI and MS and the safety and effectiveness of the CCSVI treatment procedure in MS patients has not been established.
• You should know that serious complications can occur as a result of CCSVI treatment procedures. Before you have any CCSVI procedure, discuss with your physician or other health care provider the signs and symptoms of such complications. If you have the procedure and you develop any of the signs or symptoms of a complication, contact your health care provider immediately.
• Before considering CCSVI treatment, discuss the potential risks and benefits with a neurologist or other health care provider who is familiar with MS and CCSVI (including the CCSVI procedures and their outcomes).
• If you decide to undergo diagnostic and/or treatment procedures for CCSVI, continue to follow the MS treatment plan outlined by your neurologist or the provider caring for your MS.
• If you are considering participating in a clinical trial for CCSVI, learn as much as possible about the clinical trial and ask questions of the health care team conducting the trial. Read the informed consent document carefully, and ask for an explanation of anything you do not understand. You can find additional information and recommended questions to ask your health care team on the Understanding Clinical Trials page of www.clinicaltrials.gov1.
• If you undergo treatment for CCSVI and experience a complication, we encourage you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Znači:

...sama procedura se navodi kao "eksperimentalni tretman",
...nedostaju jasni dokazi o postojanju CCSVI-a,
...ozbiljne zdravstvene komplikacije mogu nastati kao posljedica procedure tretmana CCSVI-a.