FDA to Address Complaints Related to LASIK Eye Surgery

David Mittleman — Fri, 16 Oct 2009 10:25:00 GMT

In recent years, LASIK eye surgery has become increasingly popular. In fact, an estimated 6 million patients have undergone the surgery since its inception. While eye surgery advocates cite that 95% of patients are satisfied with the results of the surgery, the Food and Drug Administration has received some complaints. Specifically, the FDA said it received 140 LASIK-related complaints between 1998 and 2006. However, the FDA has not yet taken the time to investigate the reported issues with LASIK, including permanent damage to the eyes such as double vision, dry eyes, and “halos” appearing around objects at night.

But now the FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience adverse side effects. The first phase of the project has already begun, which is sending questionnaires to patients to fill out after receiving the surgery. The second phase includes a clinical trial that will track patients who received the surgery, which will end by 2012. The FDA also sent warning letters out to 17 LASIK recently for failing to adequately report the adverse side effects of LASIK surgery.

LASIK procedures have fallen off in popularity in the last few years with the continuing economic crisis. The procedure is rather pricey, with an estimated cost between $1,500 and $5,000.

Originally posted at InjuryBoard by David Mittleman

Proteins Used in Spinal Fusion May Cause Serious Complications

David Mittleman — Fri, 03 Jul 2009 10:00:00 GMT

A recent study conducted by Brigham and Women’s Hospital revealed that a bioengineered protein used during spinal fusion procedures to correct neck pain caused more complications in patients who received the protein when compared with those who did not.

The bioengineered protein mimics natural substances that promote bone growth. The FDA first approved bioengineered proteins in 2002, but only for use in spinal fusions to alleviate back pain. However, surgeons are also free to use the protein to treat cervical (neck) pain. Nonetheless, the FDA issued a warning last year after receiving reports of life-threatening complications such as swelling of the neck and difficulty breathing.

One of the manufacturers of the protein is the maligned Medtronic, who has seen their fair share of lawsuits resulting from defective products. Medtronic’s protein, Infuse, is at the center of a controversy in which Army officials have accused a Medtronic consultant who was a former military doctor of falsifying data in a study about the product.

Originally posted at InjuryBoard by David Mittleman

Michigan Personal Injury Blog - Complications

FDA to Address Complaints Related to LASIK Eye Surgery

Proteins Used in Spinal Fusion May Cause Serious Complications