Physician to Physician Discussions > Swelling Of Eye After Photofacial
lux g is correct
suggest 36j 15 ms pass one minimal overlap, second pass 20j 5 ms this second pass is for overall redness
swelling normal, if persists check patient and prescribe medrol dosepak
not sure what you mean by 10 pulses overlapping, though
TY MD
Patient with Rosacea often swell after IPL treatments. In my experience, type II patients with "red" pigments changes even without dx of Rosacea can swell after an aggressive treatment. The problem is that if you don't treat them aggressively, you won't get good results. I use a Syneron Aurora IPL/RF machine so I don't know your settings in relation to strength of treatment. How is she now?
SD MD
You HAVE to report this to the FDA via mandatory reporting form FDA 3500A. If you do not, you will be exposing yourself to a lawsuit should this customer complain further, report the incident herself, or should the same happen to another client. The problem is when physicians look at swelling, redness, and discomfort from IPL and Laser treatments as "normal." Any discomfort or injury (swelling and redness are injuries) not explicitly stated as "normal" in the manufacturer documentation ARE NOT NORMAL and REQUIRE FDA reporting.
Cover your rear! A report documents your desire to do things right, document patient injuries, and care for consumers. NOT reporting this exposes you to inquiry by the FDA which has oversight over your business. Put the ball in the manufacturer's court. If these results were not described to the FDA in 510k and/or PMA filing, they are NOT NORMAL.
Mickey Couvertier, CBET, CLRT
We consistantly have swelling when treating rosecea patients with the Lux G. In fact, when doing our consultations we drum into their head that they can expect 48-72 hours of swelling, but that in some rare cases it can last a week. We also have them leave with ice packs and strict intructions to apply them as much as they can. Also, taking benedryl at night and using cortizone post treatment has made a world of difference for us. What you are describing is a very normal response. If you had squares and blisters, that is not. Would I report this? No, Palomar will be the first to tell you that these are normal responses that are seen post treatment. Did they sign their consent? Did you take pictures? Then you should be covered.
Derm
"Should" be covered is one thing, but medical devices and procedures are neither governed by manufacturers, nor by assumptions. If you do a search for medical spa lawsuits, warning letters from the FDA, and recalls due to injuries previously considered "normal" you will see that covering your rear is much better advice than "ehhh... it's normal."
I am regularly used as an expert witness in medical spa lawsuits, and am usually hired by the attorneys for the doctor. Even so, the majority of the cases are settled out of court because the doctor made assumptions the law does not care about. Consumers do not care what assumptions a doctor makes, and a consent form is not a license to injure a patient- believe me, I have seen many release/consent forms torn to bits by simple legal testimony.
Palomar's official documentation states "minimized redness or swelling may occur." By what standard is 48-72 hours of swelling "minimized?" A doctor may consider this minimized swelling or redness, but if a customer is discomforted to the point of complaint, the complaint is justified regardless of what the doctor assumes.
Of course, you can take my advice with a grain of salt. I don't have a PhD, or an MD...
Mickey Couvertier, CBET, CLRT
A little malar oedema is quite common after aggressive IPL. Cooling and steroids can help. If the skin is not blistered then this should settle rapidly. Some patients require a little hand holding. I have never seen it last more than 5 days in worst case scenario. How ia your patient now?
Dr Sanjay
A client came in for photo facial Saturday, skin type #2, flushing in cheeks and minor sun damage. She had been disappointed with treatments from another center.. Red flag?
I used a Palomar Lux G, 20ms 40jcm2 dropping settings for the nose area. I applied Laser Aid shields to eyes before treating and Humatirx to skin. I treated once and probably 10 pulses overlapping. Sunday I get a call she is swollen and brown spots.. Yes, to be expected as I told her. Under her Left eye there is swelling and the cheek is puffy. Today she called to say the swelling had not gone down under her eye. At first I thought she could be allergic to the adhesive from the Laser Aid but now she is complaining the swelling has not gone down.
She says she's using ice. Any suggestions? She will be coming in tomorrow for me to see her. I have photos from Sunday if anyone is will to look and share their experience.