Off-Label Use not cause for Lawsuit, Appeals Court Says

Patients cannot sue a doctor who uses a drug or device for an off-label, unapproved use as long as the use is therapeutic and not research-oriented, and as long as the doctor is providing proper, acceptable care, according to a ruling made yesterday by the Ninth US Circuit Court of Appeals in San Francisco, says a San Francisco Chronicle article.

The case before the Appeals court had to do with LASIK patients treated with a certain type of LASIK device made by Nidek Co. In 1998, the device was approved by the FDA for treating nearsightedness. It was not approved for treating farsightedness until 2006; however, the patients involved in the potential class-action had been treated with the LASIK device for farsightedness before it was FDA approved for that use.

None of these patients could show they had been injured by the off-label use, just that they had not been aware the treatment was off label.

The court ruled as long as the use of the device is therapeutic and does not harm the patient, doctors are not obligated to disclose whether a device is being used off label.

Doctors can still be sued for negligence leading to the injury of a patient.

If you are interested in LASIK or another laser vision procedure to correct a refractive error, please contact an experienced eye surgeon in your area using our directory.

Possible New Laser Surgery for Presbyopia

A laser vision procedure called Intracor can treat presbyopia without creating a corneal flap and without ablating the epithelium. A corneal flap – such as the one created in LASIK – gives a surgeon access to deeper layers of the cornea by creating a hinged door that can be folded back. Ablation, on the other hand, vaporizes the very outer layer (epithelium) of cells on your eyes to provide access to the deeper layers of the cornea.

In the Intracor procedure, a laser beam actually focuses past the surface of the cornea and targets the stroma – the layer beneath the epithelium.

The new procedure is not yet approved in the US, according to Healio.com. In a study of 63 eyes treated with Intracor, more than 70 percent of the patients said they were satisfied with the results, but 20 percent said they were dissatisfied. A 20 percent dissatisfaction rate is rather high, compared to the same rates for LASIK, cataract surgery, PRK and other laser vision procedures.

If you have age-related farsightedness because of presbyopia, an experienced eye surgeon can help you find an effective treatment.

To find out if a laser vision correction procedure like LASIK is right for you, please contact an experienced eye surgeon in your area through our directory.

LASIK Candidates

If glasses or contact lenses have become a burden and you long for a permanent solution for vision correction, LASIK may be just what you have been waiting for. However, simply wishing to be free of prescription eyewear and being a good LASIK candidate are not necessarily the same thing.

LASIK Candidacy

LASIK can be used to correct common refractive errors such as:

• Myopia (up to -12 diopters)
  
• Hyperopia (up to +6 diopters)
  
• Astigmatism (up to 4 diopters)
  

In some cases, LASIK can also be used to treat presbyopia, but this is best determined by your ophthalmologist.

The best candidates for LASIK are:

• At least 18 years old
  
• Generally healthy
  
• Free of systemic illnesses or autoimmune disorders
  
• Not pregnant or nursing
  

In addition, you will need to have healthy corneas with sufficient thickness to support a LASIK flap. However, advancements in LASIK technology have made corneal thickness less of an issue.

The best way to determine if you are a good candidate for LASIK is with a thorough examination from an experienced eye doctor. If LASIK is not right for you, you may be eligible for other procedures that can restore clear vision and help free you of prescription eyewear. Your ophthalmologist can discuss this with you in more detail during your initial consultation.

If you would like to learn if you are a good candidate for LASIK, please contact an experienced eye surgeon in your area today.

How much does LASIK Cost?

LASIK cost depends on various factors, including:

• Geographic location of LASIK surgeon 
• LASIK surgeon's experience and training 
• LASIK surgeon's technology and techniques 

Currently, LASIK procedures can range anywhere from $500 to $2,500 per eye. The wide disparity in cost is a result of the factors listed above. LASIK surgeons who use advanced technology, like Wavefront or bladeless technology, may have a higher fee than other LASIK surgeons.

So how do you factor in cost when choosing a LASIK surgeon? Don't go with the cheapest one. Cut-rate LASIK for only a few hundred dollars may be something to be cautious about. Oftentimes, these stated prices may be leaving some fees out, which you won't find out about until later. 

Similarly, choosing the LASIK surgeon who offers the most expensive procedure does not necessarily guarantee good results.

When talking to a surgeon about cost, ask whether the procedure is bladeless and whether Wavefront custom mapping will be used. If you want these technologies used in your procedure, the cost may be on the higher end.

In addition to asking about cost, ask about the LASIK surgeon's experience and training. Your surgeon should have lengthy experience performing LASIK, and should be able to tell you about some of the results achieved for past patients.

To find an experienced LASIK surgeon in your area, please use our contact form.