IMPORTANT SAFETY INFORMATION
- PROLARYN GEL or PROLARYN PLUS is contraindicated in the presence of foreign bodies, acute inflammation, infection, inadequately controlled malignancy or rapidly advancing disease when
these involve the laryngeal or upper respiratory tract.
- Do not use PROLARYN GEL or PROLARYN PLUS in patients with bilateral laryngeal paralysis and vocal disorders of psychogenic or emotional origin.
- PROLARYN GEL (injectable implant) is a resorbable implant indicated to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
PROLARYN GEL is a temporary implant and resorbs within a period of 3-6 months.
- PROLARYN PLUS (injectable implant) is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent.
PROLARYN GEL and PROLARYN PLUS injections augment the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation.
Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.
Warnings and Precautions:
- PROLARYN GEL should be administered by a trained otolaryngologist or experienced head and neck surgeon.
PROLARYN GEL and PROLARYN PLUS should not be injected into blood vessels. Injection into blood vessels may cause platelet aggregation, vascular occlusion, infarction, embolic phenomena or hemolysis.
Do not over-inject the vocal fold. In extreme cases site rupture could occur.
- PROLARYN GEL and PROLARYN PLUS must be injected into viable tissue for effectiveness. Scar tissue and significantly compromised tissue may not coapt appropriately.
Patients who have had multiple surgeries may not be appropriate candidates for bulking injection treatment.
- Airway obstruction can occur immediately and up to 7 days following injection. This results from aggressive vocal fold injection, over-injection or laryngeal edema from trauma and manipulation of the larynx.
- For PROLARYN PLUS, therapy should be delayed at least 6 months following the onset of the paralysis and /or until an adequate trial of voice rehabilitation has been made.
- For PROLARYN PLUS, some injectable implants have been associated with hardening of the tissues at an injection site, migration of particles from an injection site to other parts of the body and/or allergic or autoimmune reactions.
- For PROLARYN GEL, the injection procedure and the associated instrumentation procedures have an inherent risk of infection and/or bleeding.
- For PROLARYN GEL, lack of effect is possible. In some cases, initial treatment may not be effective and additional injections may be indicated.
- Safety and effectiveness of PROLARYN GEL and PROLARYN PLUS during pregnancy has not been established.
The following adverse events were received from post marketing surveillance for PROLARYN PLUS: infection, over-injection/under-injection, ineffective treatment,
tissue displacement, exposed material, superficial injection, edema, pain, stiffness at injection site and extraction of material.
Please see Instructions for Use for PROLARYN GEL and PROLARYN PLUS or call Merz Customer Service at 866-862-1209