Integra LifeSciences Collagen Membrane, HeliMend - Manual (Page 5)

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• Hypersensitivity reactions have been noted with the use of
other products containing bovine collagen; therefore, the
possibility exists of developing a local sensitivity response to
HeliMend absorbable collagen membrane.
• It is the responsibility of the clinician to instruct the patient on
all appropriate contraindications, side effects, and precautions as
well as to seek the services of a trained dental professional if there
are any changes in the performance of the membrane (e.g.,
infection, pain, any other unusual symptoms that the patient has
not been told to expect). If these conditions occur, the patient
should be instructed to see a trained dental professional immediately.
Precautions
• As with all surgical procedures, caution should be exercised
when treating medically compromised patients such as
patients receiving long-term steroidal therapy or currently
taking anticoagulants.
• Patients with clinically significant diseases, indicating a history
of anaphylactic reactions, autoimmune disease, uncontrolled
diabetes or severe hypertension have not been implanted with
the device; therefore the safety and effectiveness for these
patients has not been demonstrated.
• The safety and effectiveness of the device has not been evaluated
in pregnant women or children. Therefore, caution should be used
in these patients.
• HeliMend absorbable collagen membrane cannot be resterilized.
Opened, unused HeliMend membrane must be discarded.
• HeliMend absorbable collagen membrane is not intended for use
on defects outside the indications stated.