Long-Term Effects of Polyacrylamide Hydrogel on Human Breast Tissue

Abstract

Polyacrylamide hydrogel is an atoxic, stable, nonresorbable sterile watery gel consisting of approximately 2.5% cross-linked polyacrylamide and nonpyrogenic water. Polyacrylamide hydrogel is widely used in ophthalmic operations, drug treatment, food packaging products, and water purification. In the former Soviet Union, polyacrylamide hydrogel has been used in plastic and aesthetic surgery for more than 10 years, and Kiev City Hospital treats approximately 300 women a year for breast augmentation using the polyacrylamide hydrogel Interfall (Contura SA, Montreux, Switzerland). Capsule shrinkage following these injections has never been observed. The authors examined breast tissue samples from a total of 27 women who had polyacrylamide hydrogel injected at Kiev City Hospital up to 8 years and 10 months earlier. Age at operation, duration of polyacrylamide hydrogel implantation, history of possible side effects to the gel injection, other intercurrent diseases, the reason for present open breast operation, and breast palpation findings before operation were in each case compared with the histological findings on samples taken from breast tissue bordering the gel. The gel presented itself as a dark violet, homogenous mass with a rounded or ragged outline in large or medium-size deposits and as elongated strands, which mimicked the extracellular matrix, in small deposits. Histological findings of the breast tissue bordering the gel showed three different patterns: large collections of gel gave rise to a thick, soft-looking cellular membrane of macrophages and foreign-body giant cells; medium-size deposits were surrounded by just a thin layer of macrophages; and small deposits were not associated with any reaction in the surrounding tissue. Projections of the cellular soft membrane, known as granulomas, were seen in six patients. The granulomas were composed of macrophages, foreign-body giant cells, lymphocytes, and blood cells. A thin layer of fibrous connective tissue was occasionally present around the foreign-body membrane, but the thick fibrous capsule, which has been described in connection with silicone implants, was completely absent. The gel changes could be correlated to neither time since gel injection nor a history of recent injury or inflammation. It is concluded that the polyacrylamide hydrogel Interfall, which has been used in the former Soviet Union, is stable over time, nondegradable, confined to the breast, and diffusion and migration resistant. When the hydrogel is injected in medium-size or large quantities a cellular foreign-body reaction occurs, but in small amounts it is capable of splitting up individual connective tissue fibers and fat cells, substituting for the extracellular connective tissue matrix without eliciting any foreign-body reaction. As far as these data are concerned, polyacrylamide hydrogel is well tolerated by the breast and does not give rise to severe fibrosis, pain, or capsule shrinkage. However, to determine safety with more certainty, a larger sample size would be necessary.

Regenerative and innovative joint medication in the horse – Part 2: Efficacy and adverse effects of joint medication in the horse - A review of the literature - The pathogenesis of osteoarthritis in the horse

“…Es wird beim Menschen seit einigen Jahren zur Unterstützung von subkutanem Gewebe, sowie zur Therapie der stressbedingten Inkontinenz der Frau eingesetzt (Lose et al 2006, Pallua und Wolters 2010. Humanmedizinische Studien zeigen eine gute Gewebeverträglichkeit und einen lang anhaltenden Effekt, da die Substanz in das Weichteilgewebe integriert werden soll (Fer-nández-Cossio und Castano-Oreja 2006, Christensen et al 2003, Christensen et al 2008, Bello et al 2007 …”

Complications from injectable materials used for breast augmentation

“…PAH is an extensively cross-linked polymeric soft tissue filler substance (25) that has been used in Ukraine, Russia and China for the past 15 to 20 years (26)(27)(28). PAH was originally introduced to aesthetic surgery under the name of Royamid in Ukraine in the late 1980s.…”

Peculiarities of the course, diagnosis and surgical treatment of non-lactating mastitis

“…В связи с распространением пластической и эстетической хирургии молочной железы, особенно тогда, когда речь идет об увеличивающей маммо-пластике, предполагающей имплантацию чужерод-ных материалов, возникающие в ряде наблюдений гнойные осложнения могут не только свести на нет эффект операции, но и создать угрозу для жизни и здоровья пациенток [22][23][24]. Уходя из сферы ответ-ственности пластических хирургов, больные с гной-ными осложнениями после маммопластики попада-ют в отделения гнойной хирургии, где и проводится дальнейшее лечение [24,25].…”

“…Уходя из сферы ответ-ственности пластических хирургов, больные с гной-ными осложнениями после маммопластики попада-ют в отделения гнойной хирургии, где и проводится дальнейшее лечение [24,25]. Однако в связи со сравнительно небольшим числом подобных ослож-нений врачи этих отделений часто недостаточно хо-рошо знакомы с таким осложнением, что негативно отражается и на качестве лечения.…”