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cataract surgery malpractice

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Lerbea

Junior Member
What is the name of your state (only U.S. law)? georgia
Prior to cataract surgery I specifically asked the physician if there were any reports about adverse events/problems associated with the Lens he was going to use for my cataract surgery. They said no. Many problems later I find out there are over 700 fda reports on these specific Multifocal IOL lenses. I've had further surgery to remove one lens because of the problems. With a new physician I might add.

Anyone consider this malpractice?
 


ecmst12

Senior Member
Based on what you've posted, no. There is ALWAYS a chance of adverse reaction, side effects, or unsuccessful outcome whenever a surgery is performed. It does not necessarily indicate malpractice. If the lens was still FDA approved and considered acceptable to use, then using it was not negligent in any way. Considering the number of cataract surgeries performed every year, 700 adverse events does not seem like a lot.
 

barry1817

Senior Member
lens problem

What is the name of your state (only U.S. law)? georgia
Prior to cataract surgery I specifically asked the physician if there were any reports about adverse events/problems associated with the Lens he was going to use for my cataract surgery. They said no. Many problems later I find out there are over 700 fda reports on these specific Multifocal IOL lenses. I've had further surgery to remove one lens because of the problems. With a new physician I might add.

Anyone consider this malpractice?
You asked a specific question and got a specific answer, that seems to be wrong from what you have found out. That poses two problems.

Either the doctor hadn't been aware of adverse problems with this lens, which is a possiblity, or he was aware and wasn't honest with you.

This would be like being on the horns of a dilemma for the doctor because either answer isn't what a patient would want from their doctor.
 

ecmst12

Senior Member
None of that makes it malpractice. Like I said 700 reports is a very tiny number, it's not surprising the doctor hadn't heard about any problems.

Also, the reports are only reports, not proof that the adverse reactions experienced were CAUSED by a design flaw or defect in the lens, and they could all be completely random and unrelated to each other. It's only if a pattern of many similar complaints emerges that an investigation would be warrented. The reporting is encouraged so that the FDA can watch for such patterns. This information should NOT be considered a reliable source to determine if a product is questionable.
 

Lerbea

Junior Member
Evidently you don't know much about the FDA and the Medical device reporting agency. These are reports sent in by the surgeon with surgical finds specifically stated with the manufacturer and brand of lens. These are not newspaper reports. And evidently you have never experienced being on the patient end of the spectrum.
 

ecmst12

Senior Member
I know what the reports are and the reports alone do not prove (or disprove) a problem with the product. As long as the FDA has not pulled the approval and still considers the product safe and acceptable for use, then doctors can keep using them. All surgical procedures have risks, and it's impossible to prevent all adverse reactions.
 

lealea1005

Senior Member
I know what the reports are and the reports alone do not prove (or disprove) a problem with the product. As long as the FDA has not pulled the approval and still considers the product safe and acceptable for use, then doctors can keep using them. All surgical procedures have risks, and it's impossible to prevent all adverse reactions.
Just wanted to say that this statement is, absolutely, true. Perhaps, it OP that doesn't understand how the FDA works.
 

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