Integra LifeSciences Collagen Membrane, HeliMend Advanced - 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 Advanced 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 Advanced absorbable collagen membrane cannot be
resterilized. Opened, unused HeliMend Advanced membrane must
be discarded.
• HeliMend Advanced absorbable collagen membrane is not intended
for use on defects outside the indications stated.