Integra LifeSciences Collagen Membrane, HeliMend - Manual (Page 6)

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• HeliMend absorbable collagen membrane has not been
clinically evaluated in patients with conditions involving
extremely severe defects with little remaining periodontium.
• HeliMend absorbable collagen membrane has not been
clinically tested for use in regeneration of alveolar bone, either in
preparation for or in conjunction with the placement of
endosseous (dental) implants, or in the treatment of failing implants.
• The template material is NOT TO BE IMPLANTED. It is to be
used only as an aid in shaping the HeliMend absorbable
collagen membrane.
• HeliMend is supplied in a single-use package and is guaranteed to be sterile
and non-pyrogenic unless opened or damaged and product has not
expired. The product is intended for use as an absorbable implant and
is not to be reused. Any attempt to resterilize or reuse the product/
components will damage the matrix and impair its ability to function as
intended. All unused pieces must be discarded.
Adverse Reactions
• Possible complications which can occur with any periodontal
surgery include swelling of the intraoral tissue, thermal
sensitivity, gingival recession, excessive gingival bleeding, flap
sloughing, resorption or ankylosis of the treated root, some loss of
crestal bone height, infection, pain or complications associated with
the use of anesthesia.
• As with any type of surgical therapy, the patient may
experience minor discomfort for a few days.
• Spontaneous exfoliation of the material may occur in the
immediate postoperative period if the HeliMend membrane is
not adequately covered by the mucogingival flap.