BLOG: Approved products for challenging cases needed

ByJohn A. Hovanesian, MD, FACS

I have a message for the FDA: What surgeons really need in practicing medicine in the U.S. are approved products for unusual cases.

How many orphan procedures would benefit from approved products? Besides sutureless IOL fixation, we also need approved intracameral antibiotics, artificial iris implants, corneal tattoo ink, sutures approved for permanent scleral fixation, fibrin glue designed for the eye and many more. And those examples just apply to the anterior segment.

What would it take for us to have an approved implant for sutureless (glued) fixation?

First, the FDA would need to create a streamlined path for approving a modified IOL. The cost to achieve approval would need to be in the thousands rather than the millions of dollars. The newly approved design would have flexible, difficult-to-break haptics with a larger overall diameter (at least 14 mm) than current models. The optic would be at least 6 mm with rounded edges to prevent iris chafing.

The approval process could, if the FDA chose to be cooperative, take into consideration the large collection of data already existing on procedures using unapproved IOLs. Would such a study meet the typical rigor of FDA device approval? Of course not, but what is the risk to the few patients who will be treated with these lenses? We already know that lenses designed for bag placement can work for sutureless scleral fixation, and how much better would be the results with a lens designed around this procedure?

For device companies, embarking on approval of a scleral-fixated lens would take some bravery and trust in the FDA not to make the project impossibly onerous. It’s difficult to estimate exactly how many lenses could be sold for this purpose. According to Market Scope, approximately 3,000 secondary IOL procedures are performed annually in the U.S., but we don’t know how many of those have absent capsular support and would involve sutureless IOL fixation. In other words, the business case for pursuing such an approval is quite difficult to make.

To patients, what is the value of having a lens approved for sutureless scleral fixation? With approval, device makers could promote these lenses and teach surgeons proper technique through educational events. While many of us think of promotional meetings as being too salesy, they do allow the most expert source (the company that makes the product) to teach best practices for the safest surgery. Without company-sponsored education, we surgeons must learn techniques piecemeal through peer-to-peer discussion, which leaves many novices more confused than confident in trying a new procedure. How much bravery does it take for a surgeon to offer a needy patient a procedure in which every step and every product is off-label?

If both the FDA and device companies want to give doctors what they really need, approved products for our most unusual and challenging patients would be high on their lists. However, we live in a world where it takes a small fortune to get a device approved, so the only devices pursued are those that are expected to generate a large fortune. Meanwhile, we surgeons do our best, and we should be extremely grateful to pioneers like Amar Agarwal, Frank Price, Thomas John, Chris Rapuano and many others who have shared their own pearls for how to best serve our patients.