Toxic hydrolysis product from a biodegradable foam implant

Abstract

A commercially available mammary implant containing a soft polyester polyurethane foam shell has been examined for possible diamine hydrolysis products. Fourier Transform Infrared (FT-IR) analysis has shown ester and aromatic structures present in the intact foam shell. Vigorous hydrolysis conditions using NaOH have produced a mixture with large amounts of toluene diamine (TDA) present as determined by Gas Chromatography-Mass Spectrometry (GC/MS), and GC/FT-IR. There are numerous clinical reports of the degradation of this implant shell after implantation with incorporation of fragments into phagocytic cells at the implantation site. Recent reports have discussed late pain and other allergic reactions to this implant. Release of the known toxic material, TDA, is consistent with these observations and strongly suggests that an alternative material be used in this application.

A physiologically based pharmacokinetic model for 2,4-toluenediamine leached from polyurethane foam-covered breast implants.

“…One of the degradation products of TDI is 2,4-toluenediamine (2,4-TDA). Data in experimental animals showed that the PU foam cover degraded within [6][7][8][9][10][11][12] months of implantation (2). This result was consistent with the clinical observations in patients with Meme breast implants (3,4).…”

“…Our own in vitro studies indicated that 2,4-TDA was slowly released over time by hydrolytic degradation when PU foam samples were incubated under mild physiological conditions (5,6). The amount and rate of 2,4-TDA production observed in vitro varied with the conditions of PU foam exposure (7)(8)(9). The carcinogenicity of 2,4-TDA was studied extensively in mice, rats, and other species (10)(11)(12)(13)(14)(15)(16)(17)(18)(19).…”

A long‐term in vitro biocompatibility study of a biodegradable polyurethane and its degradation products

“…These aromatic diisocyanates can be converted into aromatic diamines that are toxic and potentially carcinogenic to humans. 20,21 In clinical practice durable PUs degrade very slowly, and the risk of a toxic effect is negligible. 19,22 However, with biodegradable PUs the risk of relevant levels of toxic degradation products is higher.…”

Back to the Future: A 15-Year Experience With Polyurethane Foam-Covered Breast Implants Using the Partial-Subfascial Technique

“…In the late 1980s, there was concern that a relationship between the components derived from the degradation of polyurethane (especially 2,4 toluenediamine [TDA]) and breast cancer could exist [4]. This relation has since been disproved by many studies [18,32] including reports from the Food and Drug Administration (FDA) [18,32] stating the conclusion that the polyurethane foam is safe, that the concentration of TDA in the urine of patients with polyurethane-covered implants is minimal, and that no statistical difference in TDA concentration was found between patients with polyurethane-covered implants and a control group [16].…”