LASIK surgeons fail to comply with FDA reporting requirement
--------------------
After recklessly performing millions of LASIK surgeries over the past decade with little to no policing of its poor surgical practices and deceptive advertising, the LASIK industry is feeling the pinch. LASIK volumes have plummeted after a flurry of bad press and public outcry of widespread problems with LASIK. But this doesn't help the patients who have been needlessly harmed by an unnecessary, irreversible surgery.
When a patient suffers a complication of LASIK, the surgeon is required to file a MedWatch report with the FDA. In a press release earlier this year, the LASIK industry stated that only 140 reports had been filed with the FDA "relating to LASIK dissatisfaction" between 1998 and 2006. In issuing this statement, the LASIK industry admitted that LASIK surgeons routinely fail to comply with FDA reporting requirements. In fact, it appears that most LASIK surgeons have never filed a single MedWatch report.
The LASIK industry received Food and Drug Administration (FDA) approval to perform a destructive surgery on healthy eyes based on sloppy science and insufficient, short followup data. LASIK causes chronic dry eyes and poor night vision in approximately 20% of patients, according to a review of FDA clinical trials. These "symptoms" were not disclosed to prospective patients, even though they can be permanent and life-altering.
But one complication of LASIK has the industry concerned because public awareness of the sight-threatening complication, corneal ectasia, could further tarnish the image of LASIK. Ectasia is a progressive forward bulging of the cornea, which requires corneal transplantation in most cases. Ectasia strikes when the cornea is too weak after LASIK to withstand the stress of the intraocular pressure of the eye. Medical studies show significant, permanent weakening of the cornea after LASIK in all eyes, which may lead to ectasia years after surgery.
The incidence of ectasia is estimated to be approximately 1 in 2,500 but this number could be an underestimate due to underreporting and lack of long-term followup after LASIK. Approximately 8 million people have undergone LASIK in the
Failure of the FDA to order long-term followup of LASIK patients (post-market surveillance) and enforce MedWatch reporting of LASIK complications is to blame for lack of public awareness of the potentially blinding complication of post-LASIK ectasia. But patient groups are watching, and they want the FDA to know that they will hold the Agency accountable.
