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• W2023009718 abstract "Sir: Polyacrylamide hydrogel, also called Interfall (Gel Interfall; Ukraine Interfall Co., Ltd., Kiev, Ukraine) or Amazing Gel (Jilin Fuhua, sole producer and distributor, China), has been widely used for breast augmentation and facial soft-tissue contouring in the former Soviet Union, Eastern Europe, and China. The gel—more commonly known as PAAG in Hong Kong and China—is estimated to have been used on more than 300,000 mainland Chinese women in cosmetic procedures such as breast and nose augmentation. The figure in Hong Kong is uncertain, although it is estimated to be in the hundreds or thousands, with most of them having injections performed across the border in mainland China. Christensen et al.1 reported good results in augmentation mammaplasty in thousands of women using polyacrylamide gel injection and concluded that the gel is “non toxic, well tolerated by the breast and does not give rise to severe pain, fibrosis, and capsular shrinkage.” On the contrary, several authors have reported complications such as indurations, palpable lumps, gel migration and loss of contour, hematoma, and subsequent infection associated with breast augmentation using this product.2,3 We likewise have seen devastating complications associated with the use of injected polyacrylamide hydrogel in breast enhancement. Over the past 3 years, 11 female patients aged 25 to 45 years were referred to us for management of complications associated with the use of polyacrylamide hydrogel. Seven of them presented with gel migration to the upper abdomen, lateral chest wall, and lower neck, all proven with magnetic resonance imaging studies. Four patients presented with intractable infection, breast abscesses, chronic sinuses, or subsequent complete loss of breast tissue following serial debridement. Some form of psychological stress, anger, and anxiety to the extent of depression was evident in all the patients. Another cause of concern was fear of malignant change associated with the injection of polyacrylamide hydrogel. Acrylamide is classified as a group 2A substance (probably carcinogenic to humans) by the International Agency for Research on Cancer. It has inherent toxic properties such as neurotoxicity, genotoxicity (to both somatic and germ cells), carcinogenicity, and reproductive toxicity in rodent models.4 Acrylamide undergoes epoxidation and produces glycinamide; both compounds are genotoxic and carcinogenic in mice.5 Injected polyacrylamide gel enhances breast tissue density homogenously in mammograms. Moreover, foreign body reaction or recurrent infection can also confuse detection of microcalcification, rendering breast screening extremely difficult. The Consumer Council of Hong Kong issued a warning regarding the possible complications associated with the use of polyacrylamide hydrogel in April of 2006. After this, 243 women called its hotline and expressed concern about having received polyacrylamide hydrogel injections to their breasts. Sixty-three of these women complained of complications associated with the injection and six women have lost their breasts as a result. In mainland China, the exact number of patients who have suffered from complications associated with polyacrylamide hydrogel injection to the breast is unknown. However, realizing the magnitude of the problem and the rising number of lawsuits seeking compensation in courts, the Chinese State Food and Drug Administration called for an immediate ban on the production, sale, and use of polyacrylamide hydrogel on April 30, 2006. After this, a Shenzhen hospital sued by patients for using polyacrylamide hydrogel in plastic surgery procedures was shut down by local authorities. More class-action lawsuits related to polyacrylamide hydrogel are expected in mainland China. Polyacrylamide gel injection for breast enhancement is probably being practiced elsewhere in many parts of the world where the local regulatory authorities have not prohibited the use of the substance. We would therefore like to bring a word of caution to those who might consider using polyacrylamide gel as a means of augmentation mammaplasty, namely, that this material has uncertain toxicity and oncogenicity and is associated with the possibility of devastating infective complications and migration that cannot be overlooked. The procedure is irreversible and it is impossible to completely remove the gel once injected and should complications arise. For patients who have had polyacrylamide gel injection and remain asymptomatic, no further action other than documentation of possible migration by imaging studies such as magnetic resonance imaging or computed tomographic scanning is recommended. Ming S. Cheng, F.R.C.S.Ed., F.C.S.H.K. Chiu M. Ho, M.S., F.A.C.S. Wing Y. Cheung, F.R.C.S.Ed., F.C.S.H.K. Division of Plastic Surgery Department of Surgery Kwong Wah Hospital Kowloon, Hong Kong" @default.
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• W2023009718 date "2008-08-01" @default.
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• W2023009718 title "Polyacrylamide Hydrogel Injection for Breast Enhancement: Should It Be Banned?" @default.
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• W2023009718 doi "https://doi.org/10.1097/prs.0b013e31817d6604" @default.
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