Patient Information
The line of products offered by BioMedical Distribution are derived from human amniotic membrane and fluid. These amniotic tissues, or allografts, are transplanted to provide protection and support for native tissues in the body.
The amniotic membrane is the innermost layer of the placenta which encases and protects an unborn child. Amniotic fluid is the liquid that surrounds the baby until delivery. Amniotic membrane is made up of two layers, chorion on the outside and amnion on the inside. The amnion surrounds and contains the amniotic fluid. Amniotic fluid surrounds and protects the growing embryo/fetus.
Amniotic tissue contains vital nutrients and growth factors that are essential for fetal growth, protection, and healing.
Frequently Asked Questions:
Where do the tissues come from?
The amniotic tissues used in BioMedical Distribution allografts are donated by consenting, healthy women between the ages of 18 – 45 who have just delivered a full-term, healthy baby through elective Cesarean section. Donor mothers are thoroughly screened in advance, including a medical and social history to ensure donor mothers meet all eligibility requirements. Donor blood samples are collected and also thoroughly screened for communicable diseases.
Amniotic tissue collection DOES NOT require fetal sacrifice.
At the time of Cesarean delivery (also known as C-section), the baby is delivered and the placenta and fluid, which are typically discarded, are saved. All tissues are then tested to ensure viability and safety.
Tissues are processed in accordance with cGTP, and allografts are subjected to stringent USP testing prior to release.
How are Amniotic Tissue Allografts Classified by the FDA?
The US Food and Drug Administration (FDA) classifies amniotic tissue as a HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products). An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR part 1271 if it meets all the following criteria (21 CFR 1271.10(a)): the tissue is minimally manipulated, intended for homologous use and is not combined with other cells or tissues. There can be no systemic effect or dependence on the metabolic activity of living cells to achieve its primary function and the tissue has to have a localized effect in vivo.”
If an HCT/P does not meet all of the criteria in 21 CFR 1271.10(a) it will be regulated as a drug, device, and/or biological product and a pre-market review would be required.
What are the product risks?
BioMedical Distribution products may not provide an improvement in your condition or injury. There is a possibility of an adverse immune reaction.
This is not a complete list of risks. Discuss the potential risks and benefits of product use with your doctor or health professional.
References:
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Complements and the Wound Healing Cascade: An Updated Review. Hani Sinno and Satya Prakash. Plast Surg Int. 2013; 2013: 146764
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The Grafting of Preserved Amniotic Membrane to Burned and Ulcerated Surfaces, Substituting Skin Grafts: A Preliminary Report. Maximilian Stern. JAMA. 1913; 60(13): 973-974
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Amniotic Fluid: Not Just Fetal Urine Anymore. Mark A Underwood, William M Gilbert, Michael P Sherman. Journal of Perinatology. 2005; 25:341-348
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Growth factors and cytokines in wound healing. Barrientos S, Stojadinovic O, Golinko MS, Brem H, Tomic-Canic M. Wound Repair Regen. 2008; 16(5): 585-601
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Immunological characteristics of amniotic epithelium. Hori J, Wang M, Kamiya K, TakahashiH, Sakuragawa N. Cornea. 2006; 25(10): S53-58