According to the Invima health alert, it is the Bioglue surgical adhesive in Colombia.
The National Food and Drug Surveillance Institute (Invima) issued a health alert aimed at health personnel, medical institutions and citizens in general for the fraudulent marketing of the surgical adhesive Bioglue® Surgical Adhesive.
According to Invima, this product is used in critical procedures that, in its falsified version, represents a serious risk to the lives of patients.
Invima pointed out that, according to the official statement, the company CTP Médica SA, exclusive importer and conditioner of the product in Colombianotified the health authority about the illegal circulation of units not officially authorized.
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“These correspond to references BG3510-5-US and BG3515-5-US, with lot numbers BG000737, BG000762 and HT22671D, which were not imported through the official channel nor do they have a current health registration,” said.
The report reveals that fraudulent products present multiple irregularities, including:
- Counterfeit labels that simulate those issued by CTP Médica SA
- Expiration dates altered and different from the manufacturer’s original ones.
- Lots that do not exist or are not recognized by the official producer, Artivion, Inc.
- Branded packaging “CryoLife”, name already discontinued by the manufacturer.
Lack of traceability and guarantee, which makes it impossible to verify its origin and storage conditions. “These characteristics show unauthorized intervention of the product and the complete loss of control over its quality, which could lead to failures during complex surgical procedures and even lead to patient death,” he says.
He noted that Bioglue® surgical adhesive is used as a complement in surgical repairs of soft tissues, especially in cardiac, vascular, pulmonary and dural structures. “References ending in “-US” do not have a current health registration in Colombia and, therefore, their use or commercialization is illegal.
Invima reiterated that the only safe and traceable units are those purchased directly through the authorized distributor CTP Médica SA, who guarantees the authenticity, traceability and technical support of the product”, he explained.
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The institute formulated specific recommendations for different actors in the health system:
- For users and patients: Immediately discontinue use of any suspicious unit.
- Report the situation to the local Ministry of Health or directly to Invima.
Report incidents or adverse events through the National Tecnovigilance Program (https://farmacoweb.invima.gov.co/TecnoVigilancia/). For health care institutions (IPS) and medical professionals: Refrain from using products with unofficial references, batches or packaging. Immediately report any detection of irregular products to the technovigilance program.
“The use of counterfeit products in surgical procedures can seriously deteriorate the patient’s health status or even cause death. We invite all actors in the system to report any suspicion and ensure safety in medical care, he pointed out. the Invima.
Source: Integrated Information System
