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 Post subject: Angle-supported phakic IOLs withdrawn from the French market
PostPosted: Sun Jul 01, 2007 2:55 pm 
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OSN SuperSite Top Story 6/7/2007

http://www.osnsupersite.com/view.asp?rid=22220

Angle-supported phakic IOLs withdrawn from the French market

Angle-supported phakic IOLs will no longer be sold and implanted in France due to an alarming amount of endothelial cell loss found in a significant number of patients 2 to 3 years after implantation.

Manufacturers IOLTech/Carl Zeiss Meditec and Corneal, in accordance with the French Agency for the Sanitary Safety of Health Products (AFSSAPS), ordered the withdrawal from the market of the Vivarte and NewLife phakic IOLs (both IOLTech/Carl Zeiss Meditec) in January and the Icare lens (Corn?al) in March.

An alert was first raised in February 2006, when a warning note was distributed by the manufacturers of the NewLife and Vivarte presbyopic IOLs to all ophthalmology departments. The document mentioned cases of "explantation of these lenses due to endothelial cell loss, occurring 2 to 3 years after implantation." It also announced a retrospective study to determine the incidence and causes of this late complication.

Commercialization of the NewLife and Vivarte presbyopic lenses was temporarily suspended while the manufacturers waited for the study results. In the meantime, yearly examinations of the corneal endothelium and endothelial cell counts were recommended for all patients who had been implanted. Surgeons were also required to report all cases of endothelial cell loss to the authorities.

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PostPosted: Sun Jul 01, 2007 7:53 pm 
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Do you think I'm surprised?

FDA OPHTHALMIC DEVICES ADVISORY PANEL MEETING
OCTOBER 3, 2003

Review of STAAR Phakic IOL clinical trials:

http://www.fda.gov/ohrms/dockets/ac/03/ ... 3991t1.htm

Quote:
DR. MATHERS: Some of the subjects had very little endothelial counts to begin with, and that's going to be part of this population if you do any sizeable number. I think it would be very unwise to not have some lower cut‑off for endothelium. And I think it's appropriate to look at endothelial cell counts.

DR. WEISS: Dr. Grimmett.

DR. GRIMMETT: I agree with Dr. McCulley, but I would ask Dr. McCulley, would you set your lower threshold at like one standard deviation, or two standard deviations lower than a normal mean value for that given age range, or how would you set your threshold?

DR. McCULLEY: I suppose I'd need ‑‑ you, again, have more confidence in these counting things than I do. I guess I'd want to look at the data for normal, and for age, and one and two standard deviations before I would answer that. I would just leave it loose and for right now that it be normal for age. And I would think that would add additional comfort to all of us, and those who are really concerned about the accuracy and reproducibility of the density. But I think that would be a reasonable thing to add, that should give us all more comfort with this whole issue.

DR. GRIMMETT: Dr. Grimmett again. I agree with Dr. McCulley. I had suggested a year ago to use age stratified normal means, plus or minus one standard deviation. But I think that's debatable exactly where you draw the line. Normal for 20 to 30, for example, is about 2950 plus or minus 150 or so, something like that.

DR. WEISS: Dr. Macsai had also suggested in line with this that post‑op endothelial cell counts be done, and consideration of explantation be made if the cell count is dropping. Is that ‑‑ what does the panel ‑‑ Dr. McCulley. You're shaking your head again.

DR. McCULLEY: Again, we don't know ‑‑ we're missing so much information. We need to know what the remodeling process of the endothelial is over time based on degree of initial injury, surgical injury, and age of the patient that has incurred the injury. So I'm not sure that I would know what to say in terms of when to do it, when not to. I think it ends up being surgeon judgment to make those decisions. I don't think we can dictate anything because we just simply don't know.

DR. WEISS: Dr. Sugar, then Dr. Schein.

DR. SUGAR: I agree that we don't know, and that we have no data, you know ‑‑ having no reason to postulate a source of progressive endothelial cell loss, and having no data on what that second intervention would do to progressive endothelial cell loss, I would think that that would be actually the opposite of the recommendation that I would want to make.

DR. WEISS: Dr. Schein.

DR. SCHEIN: We can make a distinction between recommending doing a monitoring test and the timing of an intervention. So by analogy, one might recommend in a glaucoma setting, visual fields at a certain frequency without recommending when a trabeculectomy be done. And I think that there is a concern about long‑term endothelial attrition, it makes sense to recommend that the only test that we have be performed on some schedule.

DR. SUGAR: But we don't know what intervention.

DR. SCHEIN: Well, no, but we have an opportunity to, one, learn the natural history. And the other is to describe to a patient that over the last five years, you've had a 25 percent loss of density.

DR. WEISS: Dr. Sugar.

DR. SUGAR: There's a difference between recommending that the Sponsor get post‑marketing data on that, and recommending that the practitioner do that, because we don't get that data. And presumably, the Sponsor doesn't get that data.

DR. WEISS: Dr. Sugar's point is very important, and we're going to be getting into whether there should be any post‑market studies, is data that is interesting shouldn't be put in labeling. That's up to any of us here or outside to do a study. But data that would be important, we feel, for patient care, should be put in the labeling. So is the specular microscopy post‑operatively important for patient care? And Dr. Sugar would disagree. Dr. Mathers.

DR. MATHERS: I would agree that it is important to patient care. There are some patients here that had very substantial loss in cell count, and you would want to pick those up. And it would be important for that patient's well‑being that you do so at some not short interval after surgery, perhaps a year or something like that.

DR. WEISS: So if you're going to give guidance as far as when repeat specular microscopy would be done, what would you suggest?

DR. MATHERS: As early as three months, possibly six, and at latest, one year.

DR. WEISS: Somewhere between six months and a year. Dr. Macsai.

DR. MACSAI: That's not what I intended by my comment.

DR. WEISS: What did you intend?

DR. MACSAI: My intention was that in my hands and my practice, if I was to implant this device, which appears to be an efficacious device, we don't have an answer about the long‑term endothelial damage. And I, as alluded to by both Dr. Sugar, Schein and Mathers, would want to know if my patient was getting into trouble. And if they go from 28 to 2000, there's trouble right here in River City, and it's time to decide if that thing is safer in or out. And I don't want to wait until there's microcystic edema and we're transplanting that cornea in a 4 year old.

DR. WEISS: What do you recommend for labeling though? This is what you do when ‑‑

DR. MACSAI: I want to suggest ‑‑

DR. WEISS: You suggest, okay.

DR. MACSAI: ‑‑ that the practitioner follow their patients with endothelial cell counts, because that's all we have.

SPEAKER: For what time?

DR. MACSAI: Well, my personal opinion, I would say five years. And when we got all this long‑term data that comes in, and it shows that I'm off the wall, I'll be the first to stand up and say thank you. I'm wrong, and then we can change the labeling on the device, and that will be a wonderful thing.

DR. WEISS: Well, actually, you know, we don't even have to ‑‑

DR. MACSAI: Annually for five years.

SPEAKER: Oh, annually.

DR. MACSAI: Is that what you want?

DR. WEISS: And actually, we don't even have to ‑‑ and I'll defer to Dr. Rosenthal. We could just say if this was what we're trying to ‑‑ everything is a suggestion here. Even our vote is a suggestion. We could say that ‑‑

DR. ROSENTHAL: If you suggest that you put it in labeling as a suggestion, you put doctors in liability risk if they don't do it. So if it's in the labeling, and it's not done, even as a suggestion, I think it holds greater water than a suggestion.

DR. WEISS: So you might be suggesting to the malpractice attorney to take that case.

DR. ROSENTHAL: Did I make myself clear?

DR. WEISS: Malvina.

SPEAKER: You put people at medical legal risk.


Dr. Rosenthal was the Director of the FDA Divison of Ophthalmic Devices. This device was approved with NO SUCH REQUIREMENT IN THE LABELING.

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Mon Dec 03, 2007 12:56 am 
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http://www.fda.gov/foi/warning_letters/s6418c.htm

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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