Bioform's Formacryl Polyacrylamide (hydrogel) Implant

OFF THE MARKET: Replaced by Argiform®

Formacryl®: The First Water Endoprosthesis

The below information was sent to me by Andrey Korneev of Bioform (makers of Formacryl®) - Russia

WHAT IS FORMACRYL® ? FORMACRYL® is an absolutely innovative injection in the sector of cosmetic medicine.For the first time, in fact, medical science employs a product comprising 95% apyrogenous water and 5% on a polyacrylamide basis, a synthetic polymer that has already been used in cosmetics. This association guarantees maximum softness of touch; the implant (which can be injected) retains more or less the same consistency as tissue, without causing unattractive artificial effects, either visible or palpable.

WHERE IS FORMACRYL® USED? FORMACRYL® is used in medicine and plastic surgery to correct any type of secondary imperfection due to deficiency of substance: from fine wrinkles to prominent nasolabial folds, acne scars, post-operative scars, secondary scars caused by burns, and post-traumatic scars.

FORMACRYL® is also the ideal choice of implant for contouring the lips, cheekbones, etc.

Unlike other fillers, FORMACRYL® (thanks to its absolute degree of bio-compatibility) can also be used for large substance deficits without the risk of causing unexpected side effects.

IS FORMACRYL® SAFE? Eight years of rigorous and scrupulous clinical experimentation have enabled FORMACRYL® to provide the maximum safety; in fact it has been awarded the CE marking by official bodies of the European products quality control system. The very special, cutting-edge production technique – an exclusive patented process, employed for this product – guarantees (unlike numerous other similar products) the absence of the toxic monomer that usually characterises these polymers – and which is responsible for all the well known devastating secondary effects.

Analyses demonstrate that FORMACRYL® is: non toxic, non-sensitising, non-mutagenic, biocompatible, permanent, removable, and physically and chemically stable.

An added advantage of FORMACRYL® is that it is absolutely radio transparent, thus allowing differential diagnosis with structures at the implant site, if necessary.

CAN ANYONE USE FORMACRYL® ? From studies conducted so far, it has been shown that FORMACRYL® is an absolutely safe product; in fact, no sensitisation test is necessary since it has never caused any type of allergic reaction. In any event, it is advisable to inform the doctor regarding predisposition to allergies (polyallergic subjects).

WHAT HAPPENS AFTER THE IMPLANT? Immediately after the introduction of FORMACRYL® a thin natural physiological capsule is formed (forming the actual endoprosthesis), which encloses the substance, thus facilitating identification and removal (easy, not traumatic), if necessary, at any moment. The oedema that develops immediately following the implant (in normal conditions) is minimal and does not last more than 20 minutes.

There is also slight redness in the area following the injection, but this disappears within a few minutes.

Cosmetics can be used after the implant without any risk of interaction.

Within a few days, any bruising or swelling that may have existed in the area disappears (no palpable changes as it consists of 95% of water); on the other hand, there is a pleasant aesthetic effect.

HOW LONG DOES FORMACRYL® LAST ONCE INJECTED? FORMACRYL® belongs to the category IIb of “medical devices” and therefore substances that cannot be reabsorbed; in fact it can be left infinitely (unless it is specially removed) like any other artificial prosthesis.

The aesthetic effect caused by FORMACRYL® is, of course, not eternal since, with the passage of time, the skin ages and the tissues (mainly the muscles) change position and shape, creating new wrinkles and imperfections “mechanically” supported, however, by the substance injected.

IS THE IMPLANT PAINFUL? Like any other injection, FORMACRYL® also causes pain, which only lasts as long as the injection. In any event, any type of anaesthesia can be used (even local) to relieve the pain, according to the doctor’s discretion.

CAN THE IMPLANT BE DONE AT ANYTIME OF YEAR? Certainly. Heat does not interfere with the substance unless the temperature is very high. Remember that FORMACRYL® is steam sterilised at a temperature exceeding 120°C.

It is advisable, however, to avoid exposure to UVA and UVB rays for at least 24 hours after the implant; this is to prevent any change in the secondary pigmentation during the temporary inflammation caused by the implant.

COMPOSITION AND CHARACTERISTICS
FORMACRYL® polyacrylamide product for soft-tissue endoprosthesis consists of 5% reticulated on a polyacrylamide basis polymer and 95% apyrogenic water. It has the form of a colourless or pale yellow gel with the following physico-chemical properties:

refractive index: 1,344+/-0,016
dry residual content: 4,5%+/-1,5%
pH: 6,5 - 8,5
residual content of monomer: absent
heavy metals: absent
Oxidisability: Max. 2 mg of O2

PACK TYPE:

1 ml vial in a sterile blister pack

1, 2 and 6 ml (cc) prepackaged, disposable syringes

The product is supplied in a vial to be used with the special syringe

FORMACRYL® is an injectable medical device composed of filling material for surgical and dental use (designed to correct small and big deficits such as wrinkles, lines, scars). It must be implanted in the hypodermis. Superficial intradermic injection is not recommended. Do not inject the FORMACRYL® in the mucous membrane.

1 ml vial in a sterile blister pack

The product is supplied in a vial to be used with the special syringe

The Bioformacryl vs. Formacryl Debate:
TOLL-FREE PHONE 800-438643 bioformacryl@progen.it (Italy) Bioform (makers of Formacryl) reports that Progen (makers of Bioformacryl) bought some product from Bioform and tried to market it under their own trademark. Bioformacryl is not under contract with Formacryl of Russia and hence reporttedly has no new access to the Formacryl product. Andrey Korneev of Bioform (Formacryl) stated that they [Bioform] could not guarantee or comment on the quality of Bioformacryl. There is no International Trademark using the hydrophilic polyacrylamide as a tissue augmentation device hence several companies will emerge.

The Unpolymerized Acrylamide Issue
Bioform reportedly has another product coming out called "Argiform" which contains less residual unpolymerized acrylamide (0.3%) as opposed to 0.04% in Formacryl. Acrylamide is a known mutagen, carcinogen and neurotoxin. Although it is unknown just how much acrylamide can be withstood by the body. Inn all polymerized products there is a residual unpolymerized product left over. Both companies (Progen & Bioform) AND a private practice surgeon in Italy failed to respond to my inquiries. Which I found odd since two of them were totally interested and wrote back regularly until I brought this acrylamide issue up.

Medical Abstracts

Abstracts from "Dermatologia", Italian edition of the "International Journal of Immunopathology and Pharmacology - January-April 2000

INTRODUCTION The notion of filler in cosmetic surgery has been firmly conceived as a “soft” method, capable not only of correcting, but, at times, and when specifically requested, canceling a particular cosmetic blemish, despite what may be considered the basic rules of this type of treatment. However, the obvious practical limitations, mainly determined by the amount of introducible substance and, at the same time, the interest in such compounds, have increasingly driven companies to venture out in search of something that might satisfy, in a sensational, permanent manner, soft-tissue deficits potentially resolvable with a simple injection.

However, this is far easier said than done, so much so that up until now the products marketed have been little more than imitations of each other, with slight variations, but sadly lacking in innovation. Thus, hyaluronic acid, although avoiding the test necessary for collagen, is always too short-lived in its action, whilst PHEMA (for cosmetic use), that unlike PMMA is less toxic, always has certain application limits linked to the dose that can be administered prior to reaching toxic levels (0.8-13 mg/Kg). Fluid silicone has been shown to be noxious and is naturally excluded from the list, whilst particles of solid silicon suspended in solution is a product with technological defects and cannot guarantee absolute safety.

FORMACRYLâ, the new injectable endoprosthesis with regular EU certification (CE mark), has certainly opened new horizons in this sector, since it is offered as a sterile substance with proven non-toxicity, biocompatibility, and complete physicochemical stability, thus providing a double guarantee of safety and lasting effect.

In this respect, it has been possible to carry out a practical study, beginning with use of the substance for the correction of small post-traumatic, congenital or physiological soft-tissue deficits.

MATERIALS AND METHODS The subjects treated were both male and female of different ages ranging from 16 to 74 years. Overall, more than 600 implants were carried out in three years, with follow-up at 30 months, using from 0.5 to 7 cc per application up to a maximum of 47 cc in total. Parameters considered were the degree of patient satisfaction (poor, sufficient, good, excellent) and that of the doctor, the degree of difficulty (as regards the implant area and the type of deficit), short- and long-term complications and the possible need for removal of the implant.
Checks for the various evaluations were carried out in the short, medium and long term, i.e. after the first three weeks, after more than two months and more than a year on.

The areas treated were: lips, grooves and wrinkles, cheekbones, facial atrophies and hemiatrophies.

RESULTS The unexpected or undesirable effects were of a solely infectious nature, of which two broke out, quite incredibly, after more than a month. The explanation for such a singular phenomenon is without doubt ascribable to the product’s peculiar intrinsic characteristics, since FORMACRYLâ is packed so full of cross-links that it is impermeable to any cell formation (including bacteria) and only permeable to ions and O2. This means that in the event of contamination, such property prevents the feared occurrence of bacterial reproduction within the substance or the capsule surrounding it, but does not prevent the much slower and insidious external pericapsular infection that can reveal itself even some time later if failing to respect the necessary precautions to ensure asepsis at the time of the implant that, let us not forget, is in fact a prosthesis.
In five cases removal was requested: three for cosmetic reasons (two lips and labial groove) and two due to infection (a labial commissure and an upper lip).

In about 75% of the cases, it was decided to carry out a second injection in order to perfect the implant.

In all other cases, the degree of patient satisfaction was good or excellent.

CONCLUSIONS The absolute biocompatibility, readily deducible from the almost total absence of immediately visible or perceptible reactive response, the exclusive plasticity and possibility of modeling and its extraordinary capacity to maintain the same texture as the tissue in which it is implanted could almost cause you to forget the other properties of this remarkable filler, i.e. that it is permanent, (easily!) removable, radiotransparent, non-sensitising, etc. Only the high degree of patient satisfaction can mirror the surprise of the doctor who operates with such product. The implants checked even two years on have conserved not only the new form created, but also an exemplary naturalness, thanks to the extraordinary ability of FORMACRYLâ, to blend uniformly with the tissue. Objectively speaking, this product is not just innovative, both chemically and as regards cosmetic result, but undoubtedly marks a new era in resolving small implants where the doctor is no longer a mere slave of the technique, inevitably dependent on the material used, but becomes master of his own ability, being able to demonstrate it like a sculptor modelling his work.

ABSTRACT Formacryl® is designed to be used for soft tissue contour plastics, filling tissue cavities and other purposes by means of intratissue administration. It is a crosslinked network of branched polymer units containing 95% of water and 5% of polyacrylamide. The objective of this study was to examine the biocompatibility of this product and the tissue responsiveness to Formacryl®, evaluating by immunohistochemistry the expression of infiltrating cells and the production of fibrogenic cytokines. Our results demonstrated that in the post implantation period the tissue showed only mild inflammation and delayed fibroblastic response with a small number of fibroblasts. In addition, the remarkable expression of macrophages confined to the surrounded area of the Formacryl® that was observed 1 month after implantation, was found reduced 4 months after gel injection. Referring to the cytokine detection, while the monoclonal antibodies recognazing TNF-a and INF-? always showed an intense expression in the perivascular infiltrate, the staining for TGF-ß, IL-4 was virtually negative after 1 and 4 minutes. In conclusion, on the basis of these preliminary data we might suppose that the Formacryl® can be considered a highly biocompatible material.

ABSTRACT Hydrophilic polyacrylamide gel (HPG) (Formacryl®) has been recently synthesized to be used by dermatologists and plastic surgeons as an injectable material for tissue augmentation. Up to date only few studies have been performed to determine the tissue inflammatory response to the application of this new material and in particular the capacity of HPG to recruit inflammatory cells. A recent study has suggested a weak inflammatory reaction of the cellular tissue surrounding the implant and a slow and minimal gel resorption due to the infiltrating macrophages. The aim of our study was to further investigate the macrophage infiltrating cells since these are the most important cell population responsible for the phagocytosis of non-self particules. We evaluated the in vivo expression, in the human being, of the mAb CD68 using the alkaline phosphatase and monoclonal anti-alkaline phosphatase (APAAP) technique on skin biopsies obtained from 7 patients after Formacryl® implantation.

Our study demonstrated the presence of CD68+ macrophages in the upper perivascular dermis, far from the gel implant, one month after the treatment with Formacryl®. Four months after Formacryl® implantation the number of CD68+ cells appeared significally decreased.

These results suggest that HPG induces a very weak tissue response and that the infiltrating macrophages are not responsible for any evident modification in the structure of HPG and apparently do not cause gel resorption.

Scientific Committe for Formacryl®:
Prof. F. Mazzoleni Dir. I. Chirurgia Plastica Università degli studi di Padova
Prof. D. Dioguardi Dir. I. Chirurgia Plastica Università degli studi di Bari
Prof. C.Dominici Dir. I. Chirurgia Plastica Università degli studi di Perugia
Prof. T.Lotti Div. Di Scienze Dermatologiche Università di Firenze
Dr. C. Protopapa Medico chirurgo - Bologna
Dr. F. Perego Docente presso l’I. di Chirurgia Plastica di Padova
·

The Following Information Was Translated From Spanish:

FORMACRYL FORMACRYL the first endoprotesi (endoprothesis) of water for woven the soft FORMACRYL is an innovative one filler for the soft woven ones. Its new development does not consist above all alone in the fact that are a synthetic biopolimero for before the time used in the medical field, the poliacrilammide, but also and for the indeed only property that characterize it. It in facts collects all those that are requirement necessary in order to obtain an optimal system: to. and? an absolutely biocompatibile system with woven (marked CE 0123) b.. is not mutageno c.. is not allergizzante (allergenic) does not demand some test) and is radiotrasparente (unlike silicone, which you cannot see through when getting xrays), fundamental quality in order to carry out quasiasi diagnosis differential between system and woven of varied nature and. and? permanent, it belongs to the IIb class between the medical devices f.. and? easy removable, absolute new development for a iniettabile system g.. Not migrate, stable chemically and physically in time of analogous consistency to the surrounding woven one, nearly of all the imperceptible one to the tact in as far as 95% it is constituted from water apirogena j.. Can be implanted in considerable amounts also, characteristic only, that One technical of correct system allows to correct volumetrically important defects is fundamental in order to obtain a good result and to avoid complicanze istologiche Searches In order to estimate the biocompatibilità of the Formacryl they have been executed for beyond five years biopsies on the tressuti of the mammals, with controls from the third day until more than a year after implantaion. The result have demonstrated a degree of absolute biocompatibilità, with one minimal inflammatory answer, insufficient edema and to regulate answer neutrofila nell?immediato period post-system. The macrofagica migration begins more late and, at a distance of approximately fifteen days, the woven formation of one is had the thinnest cap of connecting tissue, without cellular infiltrations internally. Subsequently the woven cap of connecting tissue, comes replaced from a row of fibroblasts without signs of fibroplasia (which is when fibrous connective tissue grows and can cause problems).

Interview With Bioform (Russia)

[begin interview]

Marianne: what is the average expected cost?

Andrey Korneev: The expected cost should be about 250 USD for 1 ml, plus the work of the surgeon, In Europe, it costs about 350 USD for 1 ml plus 600USD for the operation. In Russia the cost is about 200 USD for 1 ml

Marianne: Is approval expected in the United States anytime soon

Andrey Korneev: Now we are looking for US Distributors who can make certification for USA. Even we are ready to sell this material under another trademark. I think that we decide this problem in the nearest 1-2 years.

Marianne: Do you have any before and after photos to see or of the treatment or a photo of the bottle or syringes it comes in, diagrams, care reports, etc.?

Andrey Korneev: In the nearest month we translate the research for our Italian partners into English and if you are interested we can send it to you. Now we can send you some photos.

Marianne: What significance is it to have apyrogenic rather than straight normal saline or H2O in general?

Andrey Korneev: Apyrogenous water us the water produced by double distilirization [sic]. But now the latest products consist of 95%saline. It makes the product less painful.

Marianne: Polyacrylamide is derived from acrylic acid, being an unsaturated liquid acid that is obtained by synthesis is easily polymerized - what other products for use in the body contain acrylic acid derived products and what size Dalton is the average microsphere itself?

Andrey Korneev: I cannot answer this question for sure because I don't understand the meaning of the question for sure. But now our company begins research about usage of polyacrylamide materials in another places in body.

Marianne: What countries is Formacryl currently available in?

Andrey Korneev: Now Formacryl available only in three European Companies. Italy, Germany, Russia. Now we begin the program for going our product to another European countries.

(note: Formacryl is now being offered in Brazil, Mexico and France, legally or legitimately, I don't know.)

Marianne: Is it indeed a foreign body and encapsulated or treated as your own tissue.

Andrey Korneev: Material in body covered by capsule but this capsule is very thin and if you touch it, it seems like your own tissue. I think that you will find this information for sure when we send you the research

Marianne: Is it permanent and how can it be removed, if necessary?

Andrey Korneev: Material is permanent and stays in the same consistency forever so you can remove it at anytime by syringe.

Marianne: How many years has this product been used?

Andrey Korneev: The first usage of Formacryl was in Russia more than 10 years ago.

Marianne: Thank you so much for your time, we have many visitors who are willing to travel for this product

[end interview]

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