Medical concern increases over the safety of AlloClae in breast implants

The introduction in the US market of a new injectable filler for breast augmentation, made from adipose tissue from cadavers and marketed as AlloClae, has generated expectations among those seeking alternatives to traditional implants.

This product, presented by Tiger Aestheticssince the end of 2024, promises immediate results and record-breaking recovery time. However, Tommaso Addona, president of the New York Plastic Surgical Group, has warned about specific risks: the substance can cause anomalous images in studies for breast cancer detection, which in turn could cause false alarms and unnecessary invasive procedures.

The debate over the long-term safety of this technique, disseminated by the American tabloid New York Post, intensifies in the face of the enthusiasm of numerous plastic surgeons who promote it on social media, despite the scarcity of solid clinical data in humans. Currently, the scientific backing for the use of AlloClae is limited. A recent meta-analysis cited by the American tabloid New York Post included only ten human studies, covering 93 patients with follow-up mostly less than two years.

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This limited volume of evidence prevents guaranteeing the safety of the procedure in the long term, especially regarding the potential development of fat necrosis —the death of adipose tissue— or the formation of cysts and calcifications that can be confused with signs of tumors in mammograms.

The very own Addona, who has performed more than 10 thousand breast surgeries during his career, specified: “If the patient's own fat is used, the probability of necrosis is low, but not zero. With a donor's fat, I don't know what the real risk of non-integration would be.” The injectable filler of AlloClae is designed to "maintain the natural three-dimensional structure". According to Tiger Aesthetics, the product is sterilized and the donor's DNA is extracted. Its administration is carried out through a simple outpatient intervention, generally without general anesthesia, allowing for a quick recovery. "Basically, the same day, the person can return to their daily life," Addona explained to the American tabloid New York Post.

The main appeal lies in offering a solution for those patients who do not have enough of their own body fat reserves to perform an autologous transfer — a situation that the surgeon estimates affects only 5% of those interested — and in reducing the rest time, which in a conventional lipotransfer extends up to six weeks.

Concerns about the impact on breast health

The concerns surrounding this procedure focus on its impact on breast health. If the filler of cadaveric origin fails to incorporate properly, it is possible that hard and suspicious masses may arise, which, in imaging exams, mimic cancerous lesions. "That would generate concern, because a radiologist could consider the finding suspicious and recommend more follow-ups, assessments and even biopsies, with additional challenges for the patient and greater anxiety," Addona emphasized to the American tabloid New York Post.

Although preclinical studies in animal models did not show necrosis after six months, Addona warned that the long-term results in humans remain unknown.

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"The body's behavior changes over time; what seems safe after one or two years can be modified in the third, fifth, seventh year or more," he pointed out. Therefore, the specialist demands clinical evaluations of between two and ten years before considering the routine use of the product for breast augmentation viable.

Lipotransfer remains the standard due to the scarcity of human data

Although the rise of autologous lipotransfer has reduced the dependence on traditional implants, this alternative is not suitable for all patients: it requires the existence of significant fat deposits, preferably in the abdomen or thighs

According to Addona, even in cases of thin corporality, sufficient tissue is usually found for the traditional procedure, which has accumulated decades of empirical support. AlloClae, despite complying with the regulations of the Food and Drug Administration (FDA) as a product derived from human tissue, does not require full approval from the US regulatory agency. Unlike with other injectable substances like Botox, its certification is limited to origin and processing control; its use has been left to the medical community itself, which offers it for buttock augmentation and hip remodeling with more enthusiasm than caution. The expectations generated by the ease and speed of the procedure —which allows a return to light activity in 24 hours— have boosted its popularity on social media. However, Addona points out that, until there are longer-term follow-up studies, he will refuse to apply AlloClae in breast augmentations. "I would like to see studies that rule out recurrent complications such as swelling or rejection, which could be interpreted as dead tissue or poorly incorporated necrosis," concluded the specialist. Tiger Aesthetics, the firm behind AlloClae, did not respond to the query made by the American tabloid New York Post about these questions.