澳大利亚研究人员正在进行临床试验,测试一种由聚己内酯制成的3D打印生物可吸收支架作为传统乳房植入物的替代品[1]。该支架具有90%的孔隙率,最小尺寸为100立方厘米,重量仅10克[1]。医生将患者自身脂肪注入支架中,支架在2至3年内逐步被吸收,最终留下再生的脂肪组织[1]。
首次试验涉及42名曾有硅胶植入物的女性,其中19名患者接受了手术,结果显示患者保留了83%的乳房体积,且未出现严重不良反应[1]。第二阶段试验将扩展至106名女性,包括从未植入过乳房植入物的女性[1]。
澳大利亚药品管理局(TGA)的批准仍在等待中[1]。预计2028年后,该技术可供已移除植入物的患者使用[1]。
Australian researchers are conducting clinical trials of a 3D-printed bioabsorbable scaffold designed to replace conventional breast implants [1]. The scaffold, made from polycaprolactone with a 90 percent porosity rate, serves as a framework into which doctors inject patients' own fat tissue [1]. Over a period of two to three years, the scaffold is gradually absorbed by the body, leaving behind regenerated fatty tissue [1]. The device weighs just 10 grams and has a minimum size of 100 cubic centimeters [1].
The initial trial phase involved 19 surgical procedures among women who had previously received silicone implants [1]. Patients retained 83 percent of their breast volume following the procedure, with no serious adverse reactions reported [1]. The second phase of testing will expand to include 106 women, both those with previous implants and those without any prior breast augmentation [1].
Professor Anand Deva, director of plastic and reconstructive surgery at Macquarie University, is leading the research effort [1]. Regulatory approval from Australia's Therapeutic Goods Administration is pending, with the scaffold potentially becoming available to patients who have had their implants removed after 2028 [1].