Lipoderma FAQ
Lipoderma is a human adipose tissue allograft that retains the native tissue architecture and components
(extracellular matrix and signaling molecules) to restore volume and is intended for use in the repair,
reconstruction, or replacement of adipose defects.
Lipoderma is processed to meet the FDA’s requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) under the Public Health Service (PHS) Act Section 361.
Lipoderma is produced at LifeLink Tissue Bank in Tampa, Florida. LifeLink Tissue Bank is accredited by the American Association of Tissue Banks (AATB), registered with the FDA (FEI: 3008286876) and Health Canada (CTO Certificate # 100144), and licensed or registered in multiple states. The LifeLink Microbiology Laboratory is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified and accredited by the College of American Pathologists (CAP). Licenses and registrations may be found on the LifeLink Tissue Bank website
Lipoderma is produced from adipose tissue recovered from eligible cadaveric donors. Communicable disease testing is performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with CLIA and 42 Code of Federal Regulations (CFR) Part 493 or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). LifeLink Tissue Bank follows strict donor screening criteria, recovery, and processing methods which are designed to prevent the introduction, transmission, or spread of communicable disease. Aseptic tissue processing is performed in a classified cleanroom environment (ISO Class 5), and numerous microbiologic cultures are collected and evaluated. Each lot is tested for sterility per USP<71>. LifeLink Tissue Bank has a comprehensive quality program that monitors standards recognized to be effective in limiting risks associated with using allograft tissue.
Lipoderma is packaged in a cryovial containing 1.5 mL of the human adipose tissue allograft. Lipoderma is shipped either frozen on dry ice or under refrigerated conditions with gel packs.
Lipoderma can be stored at -40C or colder for up to 5 years, between -20C to -40C for up to 6 months, or 0C to 10C (refrigerated conditions) for up to 6 months. When shipped frozen on dry ice, Lipoderma can remain in the dry ice shipper for up to 72 hours.
If stored frozen, Lipoderma must be thawed before use using aseptic practices. Once thawed and the
package is opened, use within 4 hours if not refrigerated or within 24 hours if stored refrigerated with proper precautions to prevent contamination or discard. Lipoderma MUST NOT be refrozen after thawing.
Lipoderma can be implanted subcutaneously using a number of different techniques that depend on the
anatomic location, the clinician’s experience and preference, and the patient characteristics. Retrograde
Page 2 of 3 linear threading is accomplished by fully inserting the cannula or needle into the middle of a fold and implanting the product along the track as a “thread” as the cannula or needle is being withdrawn. Cross-
hatching consists of a series of parallel linear threads implanted at intervals of 5 to 10 mm followed by a series of threads implanted at right angles to the first set to form a grid. This technique is particularly useful in facial contouring when coverage of the implanted region needs to be maximized.
Lipoderma is implanted using a recommended 20G cannula or needle. The use of a smaller bore cannula or
needle may result in clogging. The use of a larger bore cannula or needle is acceptable.
Yes, however, it should not be mixed with Lipoderma.
Depending on the body location and the desired results, a one-time application may be sufficient. Additional product applications may be performed at clinician discretion. For large adipose defects, it is recommended to perform multiple implantations spaced several weeks apart instead of implanting a large volume of the product at one time.
The current data demonstrate that the product remains palpable 10 months after implantation (longer term follow-up is ongoing).
No product-related adverse events have been reported to date.
A liposuction surgical procedure is used to collect adipose tissue from specific areas of the body using a
suction device and a cannula. This adipose tissue can then be processed and transferred to other areas of the body that need volume or contour improvement. However, autologous adipose tissue is not readily available as it requires a surgical procedure for tissue harvesting, which can potentially lead to donor site morbidity. Additionally, clinical outcomes are highly variable due to differences in tissue harvesting and processing techniques as well as variations in tissue quality among patients. Lipoderma is an alternative option to autologous fat grafting without these limitations: it allows for fast preparation and implantation, does not result in donor site morbidity from adipose tissue harvesting, and is produced using a validated manufacturing process that ensures lot-to-lot consistency, which should result in more predictable and consistent clinical outcomes.
Renuva, an allograft adipose matrix, consists of adipose tissue extracellular matrix only. During processing,
adipocytes (the main type of cells in adipose tissue) are removed from Renuva, resulting in the loss of the
native adipose tissue’s ability to provide volume. It can take up to 12 weeks for host (patient’s own) cells to
form new tissue at the Renuva implantation site. Lipoderma retains the native structure of adipose and
provides immediate volume when implanted.
Synthetic dermal fillers have been designed in an attempt to mimic the rheological properties of autologous adipose tissue. Although advancements in product design have occurred, fillers only provide temporary volume augmentation without proper integration with the host tissues. Autologous adipose tissue has excellent biocompatibility, and one of its advantages over dermal fillers is the absence of hypersensitivity and foreign body reactions. Consequently, autologous adipose can integrate into the surrounding tissues, leading to longer-lasting and natural-looking results. Lipoderma provides the same benefits of autologous adipose tissue without the need for a liposuction procedure.
The Future of Natural Volume