Aquafilling, or about the consequences of a risky method of correcting imperfections

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Beautiful, firm, shapely and perfectly shaped breasts and buttocks are a dream and a goal of many women. The promise of making this dream come true was the minimally invasive method of breast augmentation, which until recently was performed with the use of Aquafilling gel. Although the first results seemed astonishing, a few months after the surgery, more and more patients reported disturbing complications, from breast thickening through numerous lumps, migration of the preparation throughout the body, disproportions in the size of the breasts to irreversible damage to the breast gland. What exactly is Aquafilling gel and what does it contain? What is the breast augmentation procedure performed with this method? What side effects and complications do patients and specialists talk about? What is the risk of using this preparation and method? What do the women who have the procedure say?

Aquafilling gel and method – what is it?

Aquafilling preparation, actually Aquafilling Bodyline is a gel that, according to the manufacturer, is intended for modeling and shaping the body. According to the manufacturer’s assurances, the two main ingredients of this hydrophilic gel are saline (98%) and polyamide (2%). Aquafilling gel is a preparation used to correct the imperfections of soft tissues, including breast augmentation, shaping the arms, buttocks, thighs and calves.

The method of body contouring using this preparation is also called Aquafilling. It involves injection under the skin with a needle or a special cannula of Aquafilling Bodyline gel. The entire procedure takes about 1,5 hours and the patient is under local anesthesia. According to the manufacturer’s assurances, the use of such a method was to protect against the risk of injuries and leaving post-treatment traces or scars.

As a result of many reports and complaints from Polish patients who struggled with numerous consequences and complications after injection of Aquafilling gel On January 27, 2020, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued a decision to withdraw the preparation from the market. Although Aquafilling gel has been withdrawn from the market, another preparation has appeared in its place, with the same composition, action and purpose. This preparation was available under the name The Delines. In May 2020, this preparation was also withdrawn from the market.

The producer of the Aquafilling Bodyline gel is the Czech concern Matrixcell Ltd., while the manufacturer of its successor, Los Deline, is also the Czech company Biotrh sro As it turned out, Biotrh sro purchased the technology (know-how) of Aquafilling gel production from Matrixcell in 2019 and introduced it to the market under a new name.

What are breast implants and are they safe for patients? Read on: Can breast implants be dangerous?

Aquafilling gel – full composition of the preparation

The beginning of the popularity of the Aquafilling gel and method dates back more or less in 2010. This popularity was not related to the lower price of the preparation, but most of all to the low invasiveness of the procedure performed. Moreover, according to the manufacturer and all the data available at that time, Aquafilling had the required certificates, which was tantamount to the fact that it was approved for use as a fully-fledged medical device.

It also turned out to be a phenomenon Aquafilling gel composition. In medical information, as well as in advertising messages, attention was drawn primarily to the fact that the main ingredient constituting as much as 98% of the composition of the preparation is saline, i.e. a component that is safe for humans, administered, for example, in hospital drips. Much less was said about the remaining 2% which it was polyamide. The property of this substance was to bind salt and give the preparation an appropriate volume.

And what exactly did this two percent Aquafilling gel turn out to be? Polyamide, or rather polyacrylamide, is a preparation known since the nineties. At that time, this substance was used in aesthetic medicine treatments aimed at modeling the face. At the turn of the XNUMXs and XNUMXs, polyamide was considered a material that performs well in filling tissues because it gives permanent results. As it turned out, these theses were not based on long-term observations. Therefore, after some time after the procedures performed, patients began to experience the effects of displaced filler.

What is saline and what are its properties? Read: Physiological salt – indications, use, dosage [EXPLAINED]

Aquafilling and 2% polyamide – what does it mean for health?

As previously mentioned, it is the polyamide contained in the gel that is responsible for the complications that patients face after the Aquafilling gel treatment.

On the one hand, polyamide or polyacrylamide has a negative systemic effect, and on the other hand, it has an unfavorable local effect.

First, it turns out that once injected Aquafilling gel cannot be completely removed from soft tissue. While the entire procedure was promoted as minimally invasive, it was The polyamide in the Aquafilling gel is very invasive and integrates stably with the tissue into which it has been injected. By attaching to the tissue, it penetrates and infiltrates it so that as a result, this compound cannot be separated, dissolved or cleaned in any way. The only solution is to excise it together with healthy tissue.

Secondly, the effect of Aquafilling gel treatment it was supposed to last for about 5 years, after which the achieved effect should disappear. However, this is not possible, because polyamide, i.e. this two percent component, is a permanent filler that remains in the body and is connected with the tissues. This means that even several years after the procedure, complications related to its presence in the body may occur.

Third, polyamide causes complications such as inflammation, infection, fibrosis, and cocci. Unfortunately, side effects do not apply to individual patients, complications occur frequently.

Fourthly, Aquafilling gel dose administered during the procedure is quite high considering the toxicity of one of its components. Breast augmentation requires the application of even several hundred milliliters of Aquafilling gel. And that means that when administering, for example, 300 ml of this preparation, as much as 6 ml of pure polyamide is introduced into the body.

What is worth knowing about breast augmentation? Check: Breast augmentation – which implants to choose? What parameters should you pay attention to?

Aquafilling – who decides to undergo the procedure and why?

Aesthetic treatments with the use of Aquafilling gel were promoted as a minimally invasive method of modeling the figure and individual parts of the body. People performing the procedures offered their patients:

1. increasing the volume and improving the shape of the breasts;
2. correction of breast defects, for example as filling of cavities after previous procedures;
3. correction of the shape and size of the buttocks;
4. eliminating the asymmetry of the buttocks or their innate disproportion;
5. correction of defects and deformations of the buttocks caused, for example, by medical procedures;
6. correction of soft tissue defects of various etiologies, e.g. after liposuction.

There could be many more reasons for performing Aquafilling gel treatments, but one of the most important information for patients should be that the administration of a substance such as Aquafilling gel to soft tissue usually does not end with a positive result. The history of activities aimed at improving the appearance of the breast goes back almost 200 years. Plastic surgery specialists make it clear that injecting silicone, mineral oil, paraffin or polyamide-based gel into the breast causes complications. Therefore, regardless of incentives or advertisements, the offer of breast augmentation with such a preparation should be rejected.

Who is a plastic surgeon and what is his specialization? Read: cosmetic surgery

What is the Aquafilling treatment?

The popularity of the Aquafilling gel treatment resulted from presenting this method as safe, non-invasive and effective.

The Aquafilling procedure was performed under local anesthesia, which was usually applied to the breast or buttocks area. Infiltrated anesthetized skin was punctured with a needle and anesthesia was introduced through the cannulas. The Aquafilling gel was then introduced into the soft tissues using the cannula. After the application of the preparation was completed, there was only one puncture left under each breast on the skin, which healed after a few days. It was assumed that, two weeks after the surgery, the patient was not to notice any post-treatment scars. The entire procedure lasted about 1,5 hours.

Are you struggling with scars on your breasts? Medonet Market offers a silicone patch for the paraplegia, a sub-breast patch for anchor scars and a silicone patch for Sikatris mastopexy scars.

According to the information from the manufacturer, the treatment should be performed by a qualified team of doctors who additionally have the appropriate certificate of completion of training with the use of Aquafilling Bodyline gel. However, media reports clearly indicated that in Poland the procedures were performed by doctors of other specialties, including dentists.

What is local anesthesia and what complications can it cause? Check: Local anesthesia

Aquafilling – the price of the treatment and preparation

Breast augmentation with the use of Aquafilling gel has not gained popularity due to the attractive price of the procedure. The offered low invasiveness of the procedure aroused great interest. The price of the Aquafilling breast augmentation procedure is about PLN 6500 and more. The price of the procedure depended on the amount of gel injected into soft tissues. Thus, the cost of the procedure when administering 2x100g in each breast could be approx. PLN 11, and when administering 0000x2g – approx. PLN 50.

For comparison, it is worth mentioning the price of breast augmentation with own adipose tissue, which is considered safe by plastic surgeons. Costs of breast augmentation with own fat tissue depend on the city and clinic where the procedure is performed. The price of such a procedure ranges from about PLN 4 to PLN 500. The price usually includes the cost of liposuction, implantation of fat tissue in the breast and the cost of special compression garments to be worn after the procedure. In addition, the cost of pre-treatment consultation should be added, which is about PLN 16-000.

What else is worth knowing about breast augmentation? Check: Breast augmentation – facts and myths

Aquafilling – complications and side effects

Aquafilling gel has been withdrawn from the market mainly due to numerous reports of complications. The media often featured stories of women who trusted the assurances about the safety of the Aquafilling method and underwent the procedure. As it turns out complications and side effects of using Aquafilling gel in many cases, they occur in patients even after several years, and not one of them cannot get rid of the entire preparation from the soft tissues even after a dozen or so cleaning operations.

The most commonly reported and treated complications are the use of Aquafilling gel are:

1. inflammation of soft tissues;
2. formation of fistulas and purulent wounds unresponsive to treatment;
3. breast deformities and pain;
4. breast fractures;
5. breast exudate;
6. breast swelling;
7. inflammation resulting in mastectomy;
8. sepsis;
9. gel migration to the area of ​​the abdominal cavity with deformation of the abdominal cavity;
10. suspected BIA-ALCL lymphoma;
11. necrotic changes in the breast.

Despite numerous reports of complications and side effects after using the Aquafilling gel, the manufacturer of the preparation refuses to accept responsibility and does not agree to pay compensation for the negative effects of the preparation. The company’s representatives say that the complications after using the Aquafilling gel are a consequence of the doctors not following the procedures. They also emphasize that the affected patients did not follow the post-treatment recommendations.

What can breast pain mean? Check: Breast pain – causes, diagnosis. What is mastalgia?

Aquafilling a mastektomia

The Aquafilling gel breast augmentation procedure was performed by several dozen doctors in Poland. Some of the patients performed the procedure several times, which means that the ingredient that was dangerous for their body was injected into the soft tissues in far too high doses.

Many of the patients described in the media that the pain that accompanied them was unbearable. Additionally, there was a fever and the breasts were swollen and leaked unidentified fluid. In some cases, it was necessary to have a mastectomy as there was no other way to stop the inflammation. One of the patients on her own commissioned chemical tests of the preparation that was injected and as it turned out, it had a different composition than described in the manufacturer’s leaflet.

What are the indications for a mastectomy and how is the procedure performed? Check: Mastectomy – types, indications, benefits and risks. The course of mastectomy

If not Aquafilling, then what? – safe methods of breast augmentation

Aquafilling breast augmentation is a method that should be avoided by all women. It is worth emphasizing that in accordance with the current medical knowledge and standards in aesthetic medicine, doctors do not recommend Aquafilling or Los Deline treatments.

On this issue, it also took a very clear position Polish Society of Plastic, Reconstructive and Aesthetic Surgery based in Warsaw. The website contains information about Aquafilling and Los Deline. The announcement of the Society reads: “The letter from the Department of Supervision and Clinical Research of Medical Devices of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, received in response to the speech of the President of the PTChPRiE Board, should not be already placed on the market ‘.

Plastic surgeons agree on safe methods of breast augmentation. They are silicone implants and the method of lipotransfer, i.e. the transplant of own fat. However, they also indicate that safer and more effective methods of breast augmentation are still being sought. Implants are a medical choice, so it is not possible to guarantee XNUMX% safety when interfering with the body with something artificial, a foreign body. The implant may rupture, cause an allergic reaction, or leak, for example.

What is worth knowing about the use of stem cells in aesthetic medicine treatments? Check: Aesthetic medicine treatments with the use of stem cells – how much do they cost?