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

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• HeliMend Advanced absorbable collagen membrane has not
been clinically evaluated in patients with conditions involving extremely
severe defects with little remaining periodontium.
• HeliMend Advanced 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 Advanced absorbable collagen
membrane.
• HeliMend Advanced 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 Advanced membrane is not
adequately covered by the mucogingival flap.