Indications, Safety, and Warnings for Bioresorbable Ear Packing and Related Products from Medtronic

MEROGEL

MeroGel Bioresorbable Otologic Packing

MeroGel^® Otologic Packing is a space-occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding, and act as an adjunct to aid in the natural healing process.

Indications

MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery.

Contraindications

MeroGel is contraindicated in patients with hypersensitivity to the product.

Warnings and Precautions

Avoid packing external ear canal with adherent dressings or applying excessive pressure.
It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were to be re-used after first application.

Precaution

Store in a cool, dry place (T<40°C).

MEROGEL INJECTABLE

EPIFILM

EPIDISC

EPIDISC TM PERF PATCH KIT

INDIGO

IPC

NIM

FUSION

OSSICULAR PROSTHESES (MIDDLE EAR AND STAPES IMPLANTS)

Ossicular Prostheses (Middle Ear and Stapes Implants)

Indications for Use

The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. The physician must exercise medical judgement and consider the patient’s complete medical history. Medtronic Xomed ossicular prostheses are indicated for the functional restoration of sound energy conduction in the middle ear as reconstructive devicesor artificial replacement for the natural ossicles of the middle ear. Reconstruction or replacement of all or part of the ossicular chain may be necessary to correct structural damage of the middle ear ossiclesor conductive hearing loss resulting from a number of pathologic conditions, including but not limited to:

Chronic middle ear disease
Otosclerosis
Congenital fixation of the stapes
Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery
Surgically correctable injury to the middle ear from trauma

Contraindications

Certain conditions may preclude the selection of ossicular prostheses implants as a means of restoring conductive hearing loss including:

The presence of middle ear infection which could result in displacement of the implant(s)
Conductive hearing loss which may be restored by non-invasive methods
The operative ear is the better or only hearing ear. Reduced hearing or total deafness is at risk in such cases.

Possible Adverse Effects

Surgery of the middle ear involves manipulation of fragile temporal bones and exposes inner ear structures to the risk of surgical trauma and infections. Serious complications may arise either during or after surgery which may result in irreparable damage to these otologic structures and their functions causing irreversible partial or total loss of hearing. Subsequent surgical procedures may be required to correct these conditions if possible.

Complications which may occur include, but are not limited to:

Sensorineural deafness due to trauma during surgery
Granuloma and perilymph fistula
Post surgery displacement of the implant due to the development of scar tissue
Recurrence of oval window fixation
Vertigo
Incus necrosis
Round window closure
Labyrinthitis
Otitis media

Precautions/Intraoperative

A high degree of surgical skill is required for the proper implantation of any ossicular prostheses. Surgeons performing middle ear surgery should have received specific training in the reconstruction and replacement of the middle ear ossicles prior to attempting implantation of Medtronic Xomed ossicular prostheses. Extreme caution must be exercised by the surgeon during surgery to safeguard against undesirable results and postoperative complications.implant should be trimmed (or a shorter implant selected) if it is too long for the vestibule to avoid any contact with sensitive inner ear structures.

At a minimum, the following precautions must be taken:

To avoid postoperative vertigo and/or loss of inner ear functions, the surgeon should carefully assess the length of the implant in relation to the depth of the middle ear vestibule. The
To safeguard against postoperative sensorineural hearing loss, extreme care must be taken to avoid traumatizing the inner ear structures by unnecessarily contacting the inner ear structures with surgical instruments or the implant(s) or through the removal of perilymph from the vestibule.
As a precaution against implant extrusion through the tympanum, tissue grafts should be used as an interface between the implant and the tympanum. Similarly, a tissue graft should be employed over the stapes footplate, or alternatively, over the oval window in stapedectomy procedures to help prevent perilymph fistula or leakage of perilymph.
To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement.

Precautions/Postoperative

Following surgery, both surgeon and patient must be alert to any sign of adverse effects from surgery and the patient should be advised of the proper care of the operative ear. The following postoperative precautionary measures are recommended:

If there is any suspicion of oval window granuloma or fistula during the postoperative recovery period, an emergency exploratory tympanotomy and correction of the condition should be performed immediately.
The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient.
Magnetic Resonance Imaging (MRI) PRECAUTIONS:For ossicular prostheses with metal components:
Medtronic Xomed manufactures metal ossicular prostheses only from non-ferromagnetic metals and Austenitic medical grade stainless steel; however, slight magnetism can be characteristic of Austenitic stainless steel. While there are no known reports of MRI-related adverse effects to a patient due to any Medtronic Xomed ossicular prostheses, caution is advised when administering MRI procedures. Caution is particularly advised when magnetic fields above 1.5 Tesla are used, as the effects at such levels have not been thoroughly studied. Additionally, image artifact can occur due to the material composition of the prosthesis. Because of the potential for such artifact, alternative imaging techniques, such as CT scanning, should be considered.

Additional Information

Hydroxylapatite is the basic inorganic constituent of living bone tissue. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. In the event that minor modifications of a dense H/A head or shaft are required, it is advisable to perform all trimming or contouring with a diamond burr using copious amounts of irrigation. Smooth, even brushing strokes should prevent inadvertent breakage. Reults, based on almost 10 years of clinical experience using dense hydroxylapatite in the middle ear, suggest that implants can be placed in direct contact with the tympanic membrane without the added risk of extrusion.

However,the use of cartilage or other suitable autogenous tissue as an interface between the implant and the tympanic membrane should be left to the surgeon’s experiences and preferences.

FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain.

VENT TUBES

Ventilation Tubes

Indications

The surgeon must use medical judgment and consider the patient’s medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but are not limited to:

Chronic otitis media with effusion characterized as serous, mucoid, or purulent
Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus
Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction

Contraindications

Some conditions for which ventilation tubes may not be the therapy of choice include:

Cases of otitis media which respond favorably to drug therapy alone
Cases involving chronic otitis medica with effuctions should not be treated by insertion of membrane-style tubes
Cases of otitis media in which, in the medical judgment of the surgeon, a myringotomy alone or tympanocentesis will suffice as treatment for the condition

Possible Adverse Effects

The middle ear may develop subsequent secondary infections from either water or airborne pathogens. (Care should be taken to avoid water entering the ear.)
Clogging of the tube which may require removal and replacement (membrane-style tubes are more susceptible to this complication and only for use in ears evacuated of effusion)
Persistent perforation of the tympanum after tube extrusion
Granulomatosis reaction of the tympanum necessitating tube removal
Premature extrusion of the tube
Failure of the tube to self-extrude requiring medical intervention for removal
Allergic reaction may occur in patients with metals sensitivity
Dislocation of the tube into the middle ear cavity
Tympanosclerosis
Localized or diffuse membrane atrophy

The Medtronic Xomed Activent^® Antimicrobial Ventilation Tube was evaluated in a 12-month study in the middle ear of animals.1 While the Activent tube was formed of silicone and silver oxide and was shown to be bacteriocidal/bacteriostatic, the study showed that the material produced no significant adverse effects compared to silicone control material. Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown.

Precautions

The surgeon is encouraged to carefully choose a tube size, style, and material to meet the needs of each specific clinical situation, while minimizing adverse effects
Larger tube diameters and increasing flange size may increase the chances of prolonged tube retention and/or residual perforation
MAGNETIC RESONANCE IMAGING (MRI): For metal ventilation tubes: Medtronic Xomed manufactures metal ventilation tubes only from titanium alloys and Austenitic medical grade stainless steel; however, slight magnetism can be characteristic of Austenitic stainless steel. While there are no known reports of MRI-related adverse effects to a patient due to any Medtronic Xomed ventilation tubes, caution is advised when administering MRI procedures. Caution is particularly advised when magnetic fields above 1.5 Tesla are used, as the effects at such levels have not been thoroughly studied. Additionally, image artifact can occur due to the material composition of the tube. Because of the potential for such artifact, alternative imaging techniques, such as CT scanning, should be considered.

References

¹

Chole RA and Brummet RE, et al. Safety of silver oxide-impregnated Silastic tympanostomy tubes. Am J Oto. 1995; 16(6):722-724.

Bioresorbable Ear Packing and Patching Products