Bio-Alcamid, My Experience

Posted on the 18 August 2011 at 15:44

Having been an aesthetic practitioner for many years now, I know a thing or two about this industry. However no matter how much you think you know I have found out to my dismay that it is always possible to be convinced about a treatment that simply does not do what it says on the tin! In fact quite the opposite!
 
A few years ago I was looking for a solution for my patients who required cheek augmentation and volumising. At the time options for non surgical treatments were limited. Then I was introduced to Bio-Alcamid, a polyacrylamide gel that according to the manufacturers would be the answer to my dreams. As it turns out it has been my worst nightmare. Bio-Alcamid is manufactured by an Italian company called Polymekon. It is a polyalkylimide gel that when injected in the correct volume and tissue plane becomes encapsulated by connective tissue. As a result this prevents the gel from migrating, being non allergenic and pyrogenic and easy to remove if necessary or required. So you can imagine my horror when patients started to present months to years after their treatment with lumps all over their faces.
 
As it turns out Bio-Alcamid does migrate, can cause low grade chronic infection and is extremely difficult to remove if possible at all. This has resulted in me spending hours upon hours dealing with these complications at a huge cost to my company. When removal has been successful, patients have undergone many procedures leaving scarring and pigmentation. In some cases non surgical removal has been impossible and invasive surgical correction was required. And in some cases correction has not been possible.
 
This has been the single most horrifying experience in my medical career and has bought me close to giving up the job I love and am good at. I have never ever had a serious complication with any other treatment and have brought much happiness to the patients I have treated. But this single most distressing thing about all of this is the total lack of support and advice from the manufacturers of Bio-Alcamid. In fact to this day, complete denial that there is anything wrong with their product.
 
Unfortunately I am not alone. My research into this has shown that many aesthetic practitioners out there have had similar experiences to me. And these people are very experienced and renowned aesthetic practitioners. The stories are all too familiar with little if any advice from the manufacturer about how to deal with these complications, in fact in some cases us being blamed for incorrect injection technique. If we were new kids on the block then maybe, but when you are as experienced as we are, you know where and how to inject. Problems with incorrect injection technique materialise very quickly after treatment. So how come these complications are presenting months to years later. Could it be possible that the capsule which apparently keeps Bio-Alcamid in place is simply not strong enough to stand the test of time or natural forces? Can all of us practitioners, with our years of experience, have all performed this procedure incorrectly? I don’t think so. My main concern now is how many more problems will come out of the woodwork in the coming years, and even more worryingly is that this product is still being injected into people’s faces. However I am unaware of any insurance company that will provide a practitioner with cover for this product and my own insurers are dealing with increasing numbers of cases.
 
We all know the pitfalls of semi permanent and permanent fillers and apart from Bio-Alcamid I have not used any others. However, when this is supposedly easy to remove and provides the long term solution for patients deciding to use this product I think my actions were within reason.
 
My reasons for writing this article are to highlight this worrying situation and to call for any of you who have had experience with this product to contact me. I and those colleagues who are battling with these complications are sick of being blamed and pushed aside by the manufacturers. It’s time to act now and make them take responsibility for their actions and their product.

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Blog Comment(s) [9]

Thanks for sharing this, Lisa, I have a deep paranoia about using anything other than a hyaluronic acid or calcium hydroxyapatite as a filler.

Fab Equizi

Thank you Lisa for bringing the issue of permanent fillers/implants to our attention. I too have encountered patients suffering with implant migration after Bio-Alcamid. I feel very uneasy with the concept of permament fillers, and personally will only use the NASHA-based products. How do you feel about Radiesse and Sculptra? I think these are excellent products when used for the correct indication in the correct patient, but do you have concerns about their lack of reversibility? At least with the HAs we have Hyalase to fall back on!

Dr Ashley Hague

Thank you for the information, I am so glad that it's not only me who has suffered after having Bio-Alcamid fillers on my checks, i have been through hell with peoples comments and almost feeling suicide, what can i do to have them removed or to make my face smooth instead of having lumps that stick out like gulf balls,,, please help anyone.

Nikki Bains

5 years ago at the age of 65 I had bio alamid injection in my cheeks in spain by a Dr Sylva in a beaty clinic in Benitatchel, she rented a room there once a month. checked to see if it was safe and all came up good. I was delighted with it, took all the laughter lines away. Moved to south Africa 2 years ago as no longer could affod to live in spain. In August had a tooth abcess, put on antibiotics to try and save tooth, but had to have it removed, face swelled up badly, more antibiotics. then in september face hot, a lump beside my nose on cheek and another by my eye in the corner, not conected to the capsule, dentist though it was an abcess, put me on antibiotics and it went down. then last week came back but worse, capsule swollen, then checked bio alcamid and found the horror stories, contacted clinic, she said dentist must have pierced it, but he didnt, said only anesethic in gum, nowhere near the capsule, which I then told him about. put me on more antibiotics which arent working. Contacted Clinic again as cant talk to Doctor, she only speaks spanish, told me to get the dentist to inject antibiotic into capsule, dentist couldnt believe what she said, then said need cortisone but didnt say what, injection, taking etc and not to use anti inflamatories, again why. then said she would try and help if i flew to spain, told her I dont have over 1000 pounds to go there, I am now 70 and on pension. Never told my husband i had it done. she then said get a surgeon to inject it out, they have never tuched the stuff here and after reading stories petrified, I am now nearly suicidal, please can you help me. What to do, cant I sue her. She says she thought it was safe and now doesnt use it, but if she cared a 1000 pounds isnt much for a rich surgeon. Cant sleep, cant eat and husband just recovering from a hernia op so cant tell him, and anyway what can he do, havent got that money and he will be furious with me for having it done, and the treatment I am recieving from Dr Sylva. . Read Presidone can help, is this correct.

Vera

dear vera. i am so sorry to hear of your predicament and sympathise completely. the problem with dealing with bioalcamid issues is the lack of support and advice doctors can get from the company that make the product. it clearly does not do what we have been told and is extremely difficult to remove even by the most experienced surgeons. I'm afraid there is no clear answer for you. prednisolone and antibiotics can help with the swelling and any underlying chronic infection but the problem is the product is still present and these most probably will recur if not removed. you could try contacting dr sylva again. in my opinion any ethical dr should do their best to help a patient with a problem or certainly should investigate someone in south africa that you could be referred to. i wish you the best of luck

Dr Lisa Delamaine | http://www.personamedical.co.uk/

Why haven't you reported the adverse efects to the MHRA?

Jeremy Rouch

Dr Delamaine,

I have BA in my cheeks and would like it removed. Can you recommend someone experienced in doing so.

Many thanks.

J Billingsworth

Hi,
I had this substance injected into my lips 9 years ago. Now ,my lips are full of lumps and I lost part of my mobility when I move my mouth. Please advise on how to remove it. Thank you

Alex

Deat Dr Lisa,

In 2003 I was working in a a clinic and the dermatologist there advised me to inject Bioalcamid because I was only 37 years old and my nasolabial lines were very deep which made me look older. At the time no contraindications were known so I did it and the results were fantastic. I was never informed that this product was forbidden in USA.
Last month after dental treatments I began to feel a strange tooth/gum sensivity.
Then I noticed that I have two small lumps each on side of the nose. Only one of them is a bit swollen.
In your article you mentioned that is necessary to take antibiotics (which one?? cefaclor is good?) and Prednisolone.
I've been reading about the subject and what I've red is not good. Everybody has afraid to do any procedure on this.
What shal I do? I haven't seen my familly doctor yet but when I do I want to provived her with some information about this problem, because I have my doubts if she ever heard about Bioalcamid.
I live in Portugal.
Thanks in advance and best regards.

Ana Cristina Brizida

Ana Cristina Brízida