First you must determine the correct eyelid implant design and weight for your patient. This can be done using MedDev’s Tantalum Weight Sizing Set. Once the appropriate weight size is determined, the corresponding ThinProfile or Contour eyelid implant in the selected implant material (gold or platinum) can be ordered.

Note: Most MedDev products are in stock and available for immediate delivery.

The easiest way of doing this is to order a Tantalum Weight Sizing Set. The Standard Sizing Set consists of seven testing weights that correspond to the most commonly ordered implant sizes. The set also includes a supply of double-stick, hypoallergenic adhesive strips to adhere the testing weights to the upper lid. Alternatively, any medical grade adhesive can be used for adhesion. The two most commonly used are Mastisol and Benzoin.

Sizing is done preoperatively. Following are MedDev’s sizing instructions:

1. Place the EyeClose Adhesive Strip on the concave side of the 1.0 gram sizing weight. (Note: Instructions for use of the tape are included in the adhesive tape box.)
2. With the patient sitting upright, affix the weight to the upper eyelid approximately 3.0 mm above the lash line, centered at the junction of the medial and central thirds of the eyelid (refer to sizing set instructions). At this point the action of the levator function is maximal.
3. Note the position of the eyelid as the patient looks up and down.
4. Increase or decrease the sizing weight until the best result is achieved. Because the levator seems to strengthen after the weight is added, the optimal weight is usually that which holds the lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.

Once the appropriate weight size is determined, the corresponding implant, in the implant design and implant material (gold or platinum) preference, can then be ordered for the procedure.

The patient who has lagophthalmos with the diagnosis of prolonged or incomplete recovery is a suitable candidate for the procedure. If the facial nerve is felt to be intact and likely to recover, such as in Bell’s palsy, supportive care using a Blinkeze External Lid Weight in conjunction with ocular lubricants can be indicated for the first six months, during which time the facial nerve function can be monitored. If the paralysis resolves after implantation of an Eyelid Weight, the procedure is easily reversed.

In cases of concomitant trigeminal or 5th facial nerve loss, the cornea may become denervated. The insensitive cornea may sustain severe damage without the usual protective warning signs of irritation, pain or foreign body sensation. It is important to recognize and treat this condition early to prevent corneal damage. MedDev eyelid weight implants may be included in the treatment to prevent corneal damage.

Yes, lower lid laxity is an indication for a simultaneously performed lower lid supporting procedure.

For more information, refer to Surgical Technique

1. Jobe, R. P. 1974. A technique for lid loading in the management of lagophthalmos of facial palsy. Plastic and Reconstructive Surgery, 53, 29-32.
2. Seiff, S. R., Sullivan, J. H., Freeman, L. N. & Ahn, J. Pretarsal fixation of gold weights in facial nerve palsy. Ophthalmic Plastic and Reconstructive Surgery, 5, 104-1 09.

Typically, a 5­‑0 polyglactin absorbable or 6‑0 silk or nylon, non-absorbable is used. Sometimes a 4‑0 black silk is used.

Yes, implant placement is typically sutured to the anterior surface of the tarsus. Yet several surgeons place the implant on the edge of the orbicularis inferiorly so that the implant is better hidden in the lid crease and is less conspicuous. The functional postoperative results are the same in either placement. A septal placement may be indicated in cosmetic considerations. A lower pretarsal placement is likely to require implantation of less weight, but may be more visible in patients with thin eyelids.

In both of the surgical techniques for pre-tarsal and septal fixation the implant is placed with the rounded corners down.

The orbital septum that extends from the upper portion of the tarsal plate to the upper orbital rim is a thin sheet of fibrous tissue that attaches to the orbit just below the eyebrow. When the eye is closed lying down, this tissue is relatively flat, preventing the Eyelid Weight from going back into the orbit. If the weight is placed incorrectly behind the orbital septum, it can inadvertently pull the lid open, as the weight falls back towards the orbit on the surface of the levator muscle that is behind the orbital septum.

Eyelid edema and erythema that is experienced postoperative is typically minimal and is usually resolved within the first few weeks. In the unlikely event there remains excessive swelling, the inflammation has been treated successfully in some instances with warm compresses. Prolonged or progressive swelling may indicate a noninfectious inflammatory reaction to the Gold Eyelid Implant or a relatively non-virulent infection. Although gold sensitivities at a 99.99% purity level are rare, known gold allergies should be considered in the preoperative history. Persistent reaction is an indication for implant removal and replacement with a Platinum Implant.

Drs. Bair, Harris, Lyon and Komoroski reported in 1995 in Journal of Ophthalmic Plastic and Reconstructive Surgery on their findings regarding three cases of eyelid inflammation associated with Gold Eyelid Weights¹ The cases were successfully treated with either corticosteroid injection or, in the second patient case, with the replacement of the Gold Weight with a MedDev Implant constructed of pure platinum.

1. Bair, R., Harris, G., Lyon, D. & Komorowski, R. 1995. Noninfectious inflammatory response to gold weight eyelid implants. Ophthalmic Plastic and Reconstructive Surgery, 11, 209-214.

ThinProfile^® Eyelid Weight Implants feature a 35% reduced implant thickness combined with a proprietary three-dimensional design that conforms to the curvature of the ocular globe. ThinProfile implants are less visible than the popular Contour design when implanted because all implant edges are precisely tapered and corners are smoothly rounded.

Silver et al (2009) reported a lower risk of extrusion when ThinProfile Platinum implants were compared with gold implants¹. Patients with clinical characteristics of excessively thin upper eyelid skin with an associated increase in the risk of extrusion may benefit from ThinProfile’s reduced thickness.

Benefits:

• Restores passive eyelid closure
• Improves corneal protection
• Assists blinking
• Excellent cosmetic results

Features:

• 0.65 mm implant thickness (Contour implant thickness 1.0 mm)
• Two implant widths: 6.0 mm and 6.6 mm (6.0 mm in sizes 0.6 g to 1.2 g; 6.6 mm in sizes 1.4 g to 1.8 g) ensures the length of the implant does not exceed the medial third region of the tarsus where the action of the levator is maximal
• 12.7 mm radius of spherical curvature conforms to the shape of the ocular globe
• All edges and corners precisely tapered and smoothly rounded
• 1.0 mm implant holes for operative suture fixation and postoperative fibrous tissue in-growth
• Smoothly blended surface transitions and suture hole edges ensures tissue compatibility
• ThinProfile Gold Eyelid Implants available in six standard sizes (0.6 g to 1.6 g in 0.2 g increments)
• ThinProfile Platinum Eyelid Implants available in seven standard sizes (0.6 g to 1.8 g in 0.2 g increments) and five special sizes (2.0 to 2.8 in 0.2 g increments)

ThinProfile Platinum Eyelid Weight Implants:

• Produced from 99.99% pure platinum, nominal specific gravity 21.5
• Smallest implant available; 11% higher density than gold
• Excellent biocompatibility
• Proven alternative for gold sensitive patients

ThinProfile Gold Eyelid Weight Implants:

• Produced from 99.99% pure gold, nominal specific gravity 19.21
• Gold is a dense, inert, biocompatible metal that does not corrode and rarely causes irritation in the surrounding tissues.

1. Silver, A. L., Lindsay, R. W., Cheney, M. L. & Hadlock, T. A. 2009. Thin-Profile Platinum Eyelid Weighting: A Superior Option in the Paralyzed Eye. Plastic and Reconstructive Surgery, 123, 1697-1703.

MRI safety information for MedDev eyelid closure products was developed using non-clinical testing and received marketing clearance by the FDA in August 2015. The following information provides guidance for physicians, radiologist and MRI technologist with patients using only MedDev products in the MR environment:

MedDev MRI Safety Info – Guidance Document

MedDev Part Numbers/Reference Numbers List – Addendum to MedDev MRI Safety Info

Patient MRI Safety Information

Gold is preferred because it is a dense, inert, biocompatible metal that does not corrode and rarely causes irritation in the surrounding tissues. Dermatitis is the most frequently reported toxic reaction to gold, probably involving allergic mechanisms. Bair et al (1995) reported successfully replacing a gold implant with Platinum as an alternative for gold sensitive patients¹.

Gold is also preferred because its color closely matches the color of the surrounding fatty tissue, making the implant less conspicuous in the eyelid, even in patients with thin eyelid skin.

1. Bair, R., Harris, G., Lyon, D. & Komorowski, R. 1995. Noninfectious inflammatory response to gold weight eyelid implants. Ophthalmic Plastic and Reconstructive Surgery, 11, 209-214.

Drs. Bair, Harris, Lyon and Komoroski reported in 1995 in Journal of Ophthalmic Plastic and Reconstructive Surgery on their findings regarding three cases of eyelid inflammation associated with gold eyelid weights¹. The cases were successfully treated with either corticosteroid injection or, in the second patient case, with the replacement of the gold weight with a MedDev implant constructed of pure platinum.

1. Bair, R., Harris, G., Lyon, D. & Komorowski, R. 1995. Noninfectious inflammatory response to gold weight eyelid implants. Ophthalmic Plastic and Reconstructive Surgery, 11, 209-214.

Platinum has excellent biocompatibility and is a suitable alternative for gold sensitive patients. Platinum has a higher specific gravity than gold so that the same size platinum implant is overall smaller. The less bulky platinum implant creates a lower profile and is less conspicuous in the eyelid.

Prior to production, each lot of gold or platinum is analyzed by an independent laboratory for the purity levels of all known trace elements using ICP-MS (Inductively coupled plasma mass spectrometry) on a sample of the solid material. A broad-spectrum film is read and all impurities seen are reported in their indicated concentrations. While the analysis results may vary from lot to lot, no lot is accepted for production that is not 99.99% pure and has certain trace elements below their specified limits.

It is a standard of the jewelry industry to utilize the Caret system when describing the gold content of jewelry. It should not be considered a statement as to the “purity” of the gold. The jeweler may attempt to enhance the color of the gold by introducing additives and other metals to gold that is considered by the jeweler to be 24-caret gold. Alternately MedDev Eyelid Implants are manufactured from gold that is 99.99% pure. An independent laboratory tests each sample (“lot”) of MedDev’s gold prior to production for the presence of impurities. The levels of twenty trace elements are identified and recorded for each lot. If the sum of the impurities, including trace elements, does not exceed 0.01% or 100 part per million, then the specific testing sample (or “lot”) of gold is accepted as meeting MedDev’s purity standard of 99.99% pure gold.