November 6, 2008

FDA Issues Recall of Syringes Used by Diabetics

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Today the FDA issued a recall of Insulin syringes referred to as ReliOn. These are single-use, disposable, hypodermic syringes used by patients with insulin dependent diabetes. The syringe is mislabeled and may result in the patient overdosing by as much as 2.5 times the intended dose. This can lead to serious health consequences, including death. The syringes were sold by Wal-Mart and Sam's Club pharmacies. The recall only applies to lot number 813900. The product was distributed from August through October 8th of this year. You should check your syringe packaging carefully and do not use this product and return to the pharmacy for a replacement. For more information regarding this recall, see here.

October 22, 2008

FDA Issues Public Health Notification of Serious Problems With Surgical Mesh Used to Treat Pelvic Organ Prolapse and Urinary Incontinence in Women

Surgical mesh products are medical devices used to fix everything from hernias to prolapse of pelvic organs (uterus) to urinary incontinence seen in women sometimes after they have had several childbirths. These products can be rejected from the body and cause alot of complications sometimes making the original problem look minor compared to the ultimate problems caused by use of the mesh product. Yesterday, the FDA issued a public health notification to both physicians and consumers of the potential risks that can arise from use of these mesh products to repair some of these problems.

Specifically with regard to women who choose to have surgical mesh to address prolapse of their uterus or urinary incontinence, the FDA reports complications with the placement of this mesh including erosion through the vagina, infection, pain, including pain during sexual intercourse and recurrence of the prolapse or incontinence. In fact, a second surgery may be required to address removal of the mesh that has eroded into the vagina.

The FDA recommends many questions which need to be asked of your doctor if you need to have Pelvic Organ Prolapse or Stress Urinary Incontinence surgery. For a list of these questions, see the FDA's Consumer Information on this here.

As a consumer and potential patient, you must be aware of these potential problems and you must discuss them with your doctor to make the right decision for you. If your doctor is not willing to address your concerns or blows them off as not important, you need to find yourself a new doctor. As I said, with use of these mesh products, sometimes the repair and the ultimate results can be much worse than the original problem. Rule number one when dealing with doctors prescribing medications and recommending surgeries; ask questions and demand clear, understandable answers. It is ultimately your life and you need all the necessary and relevant information to make the right decision for you.