Transvaginal Placement of Surgical Mesh
Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals
Transvaginal Placement of Surgical Mesh- Serious Complications Associated With Transvaginal Placement Of Surgical Mesh In Repair of Pelvic Organ Prolapse And Stress Urinary Incontinence

FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks. 
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh


Thoratec HeartMate II Left Ventricular Assist System- Device Correction: Wear And Fatigue Of The Percutaneous Lead Connecting The Blood Pump With The System Controller May Cause Serious Injury Or Death
Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139), distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate


Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator- Class I Recall Because Of Unsupported Claims
Audience: Healthcare professionals
FDA notified healthcare professionals of a Class I Recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer has submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Vibe



The November 2008 Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the November 2008 edition include:

Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade
Strengthened warnings needed to draw attention to fungal infections in patients treated with TNF-alpha blockers

Serious Injection Site Reactions with Vivitrol
Practitioners should take care to avoid injecting the drug intravenously, subcutaneously, or into fatty tissue
Stories in the November 2008 edition include:

Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade
Strengthened warnings needed to draw attention to fungal infections in patients treated with TNF-alpha blockers…

Serious Injection Site Reactions with Vivitrol
Practitioners should take care to avoid injecting the drug intravenously, subcutaneously, or into fatty tissue…

Updated Warnings on Byetta
Healthcare professionals should consider antidiabetic therapies other than Byetta (exenatide) in patients with a history of pancreatitis…

Importance of Influenza Vaccination for Healthcare Personnel
Ensuring that healthcare staff are vaccinated can reduce staff influenza rates as well as nosocomial infection rates…

Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia
Boxed warning to highlight the risk of death when treating dementia-related psychosis with conventional antipsychotics such as Haldol…

Serious Hypersensitivity Reactions with Abacavir (Ziagen)
Patients with the HLA-B*5701 allele may be at increased risk for hypersensitivity reactions…

Serious Muscle Injury with Simvastatin/Amiodarone Combination
Possible increased risk of rhabdomyolysis in patients using cholesterol lowering statins (e.g., Zocor) together with the anti-arrhythmic drug, amiodarone…

Tragic Events with Concentrated Opiate Oral Solutions
ISMP offers recommendations on preventing dosing errors with opiate oral solutions…

FDA’s Drug Safety Newsletter Now Available
The latest Drug Safety Newsletter includes articles on preventing medication errors and exploring associations between reported adverse events and several drugs such as mefloquine hydrochloride, lenalidomide, and icodextrin