‘I was told this was safe’: Serious concerns over Aquafilling Bodyline (Los Deline)

Gabriela Lenarczyk        06 May 2019        Comments (0)

Aquafilling Bodyline was popularized on the Polish market approximately four years ago. The manufacturer of this polyacrylamide hydrogel (PAAG) promised to perfectly fill up irregularities, improve breasts and buttock volume during a mini-invasive procedure, and all of that with a painless and short post-operative period. If this sounds too good to be true, that is because it is. The potential risks that nobody is mentioning? Asymmetry. Deformity. Hypoechoic nodules. Intravascular leakage. 

Plastic, reconstructive and aesthetic surgeons are sounding the alarm bell about the severity of cases of breast deformity after Aquafilling injections.

Aquafilling’s empty promises

Aquafilling is composed of 2% polyacrylamide and 98% sodium chloride solution 0.9%. It was developed in the Czech Republic as a soft tissue filler for facial contouring, but is currently used for breast and buttock augmentation. The procedure of its injection is short (the gel is injected through the skin by a needle), and performed under local anesthesia. The recovery – as advertised – is expected to take just one day, with the results becoming visible after a week.

Dangers of breast enhancement gels

Asymmetry, deformity, hypoechoic nodules and intravascular leakage are just a few of many potential adverse complications of using this product, as proven with numerous reports since its debut on the market1. Current experience shows that it is virtually never absorbed, and to make matters worse, it is physically impossible to be removed. All the more shocking that it is (to this day!) widely advertised as completely absorbable and perfectly safe.

Plastic, reconstructive and aesthetic surgeons are sounding the alarm bell about the severity of cases of breast deformity after Aquafilling injections: many of them are irreversible, and may even require breast reconstruction. It proves to be a great challenge – even for the most experienced surgeons – to remove the gel completely, even with cannula suction, saline irrigation and manual physical pressure.2

The risk of complications is even higher due to the fact that the gel is injected almost exclusively without imaging guidance of e.g. ultrasonography.

Do not get lead astray: Aquafilling = Los Deline

It therefore comes as no surprise that the U.S. Food and Drug Administration (FDA)3 disallowed the use of the filler back in 2015, or that the Korean Academic Society of Aesthetic and Reconstructive Breast Surgery issued a position statement in 20164 opposing the use of Aquafilling.

However, due to these actions, as well as the high risk of complications, the gel has repeatedly been withdrawn from use, only to later be re-registered under other names. As reported by the Polish Clinic of Plastic Surgery at the Medical Postgraduate Training Centre in Warsaw5, this precedent recently took place in Poland. By the decision of the Polish Department of Surveillance and Clinical Trials of Medical Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Aquafilling Bodyline has been withdrawn from use, but returned to the market a few months ago under a new name – Los Deline. The manufacturer issued a statement informing that the change of name was made due to marketing reasons.

A lawyer’s perspective

Our firm has already been contacted by a growing number of patients suffering from adverse reactions after being injected with Aquafilling/Los Deline. Their cases take on a cross-border dimension, as the gel is manufactured in the Czech Republic, which poses certain investigation and litigation challenges. With the much appreciated help of Klara Dvorakova, in cooperation under PEOPIL, we have been able make findings as to the manufacturer of the product. We are concerned with the lack of media coverage on the topic of complications and advise all potential users of polyacrylamide hydrogels to conduct detailed research prior to deciding whether or not to undergo considered procedures.

 

1 Peters W, Fornasier V. Complications from injectable materials used for breast augmentation. Can J Plast Surg 2009;17:89-96.; Patlazhan G, Unukovych D, Pshenisnov K. Breast reconstruction and treatment algorithm for patients with complications after polyacrylamide gel injections: a 10-year experience. Aesthetic Plast Surg 2013; 37:312-20; Ono S, Ogawa R, Hyakusoku H. Complications after polyacrylamide hydrogel injection for soft-tissue augmentation. Plast Reconstr Surg 2010; 126c:1349-57.

2 Eon Rok Do, Jeong Su Shim. Long-term Complications from Breast Augmentation by Injected Polyacrylamide Hydrogel. Archives of Plastic Surgery, Vol. 39 / No. 3 / May 2012.

3 U S Food and Drug Administration. Soft tissue fillers: Dermal fillers. Silver Spring, MD: U. S. Food and Drug Administration; 2015.

4 https://e-aaps.org/upload/pdf/aaps-22-45.pdf

5 https://www.cmkp.edu.pl/struktura/studium-kliniczno-dydaktyczne/klinika-chirurgii-plastycznej/

 

 

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