Product Safety

SurgiMend is used and trusted by physicians and institutions around the world. SurgiMend is manufacturer in our ISO 13485/cGMP quality manufacturing facility, located in Boston, Massachusetts.

SurgiMend products are 510K cleared by the FDA and CE marked. Key safety parameters and attributes include:

Clinically Proven: The SurgiMend family of products have been broadly studied and are successfully used in cases ranging from hernia repair to plastic and reconstructive surgery.

Terminally Sterilized: SurgiMend products are terminally sterilized via exposure to ethylene oxide gas to 10-6 SAL (sterility assurance levels), reducing the risk of blood-borne pathogens and transmission of disease. Many tissue repair products from other manufacturers are only aseptically processed and so do not provide the same level of assurances.

Viral Safety: The manufacturing process includes a chemical viral inactivation step validated to ensure inactivation of potentially contaminating virus classes, including enveloped & non-enveloped RNA and enveloped & non-enveloped DNA viruses.

Biocompatibility: The biocompatibility of SurgiMend technology has been evaluated by a third-party laboratory in accordance with ISO 10993, the internationally recognized standard for medical implants intended for long-term use. The results show our technology to be highly biocompatible. The tests are summarized in the “Product Technology Biocompatibility Summary” table at the bottom of this page.

TSE Safety

SurgiMend has been specifically designed to safeguard against the possibility of transmitting prion-related Transmissible Spongiform Encephalopathy (TSE) diseases, including variant Creutzfeldt Jakob Disease (vCJD), the human form of Bovine Spongiform Encephalopathy (BSE), commonly known as Mad Cow Disease.

The product is derived from fetal or neonatal bovine dermis, which has been designated safe by the World Health Organization and EU scientific committees as no detectable levels of infectivity have been identified for this type of tissue.1

 

Non-Inflammatory – Non-Irritant: SurgiMend is made of Type I and Type III collagen; and is without preservatives, denatured proteins, artificial chemical crosslinks, cells, lipids, carbohydrates and other constituents, all of which can induce inflammation.

Source Materials: Our products are derived from only well-defined and characterized fetal or neonatal bovine source tissue with respect to age, mechanical strength, structure, and composition – a young and healthy tissue source of consistent thickness, predictable handling and application.

No Potentially Antigenic Antibiotics: Our products do not put the patient at risk for potential allergies to antibiotics.

No Polysorbate 20: Our products do not put the patient at risk for potential allergies to this cell lysing/preservative chemical.

Product Technology Biocompatibility Summary3

Test Performed Standard Result
Cytotoxicity, MEM Elution ISO 10993-5 No evidence of causing cell lysis or toxicity
Sensitization, Maximization ISO 10993-10 No evidence of causing delayed dermal contact sensitization
Acute Intracutaneous Reactivity ISO 10993-10 No evidence of significant irritation
Acute Systemic Toxicity ISO 10993-11 No mortality or evidence of systemic toxicity
AMES Bacterial Reverse Mutation ISO 10993-11 Nonmutagenic to Salmonella typhimurium test strains TA98, TA100, TA1535, TA1537, and Escherichia coli strain WP2uvrA
Hemolysis, ModifiedASTM Direct Contact Method ISO 10993-3 Nonhemolytic
Hemolysis, ModifiedASTM Extraction Method ISO 10993-4 Nonhemolytic
Surgical Muscle Implantation, 4 & 12 Weeks ISO 10993-6 Macroscopically and microscopically classified as a non-irritant as compared to negative control plastic

For additional information, please download and reference the SurgiMend Safety and Handling data sheet.

1WHO (World Health Organization) Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies — Geneva, Switzerland, (2010).

2EDQM Certificate No. R1-CEP 2004-116 Rev. 00 for Collagen Matrix, Strasbourg, 23 November 2004.

3Data on file, Integra LifeSciences Corporation.

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