If you have a CyPass micro-stent implanted in your eye, you need to know about the voluntary removal of the medical device from the market. In the article below, our CyPass lawsuit attorneys discuss why the manufacturer removed the device from the market and what you should do if you have already had the CyPass micro-stent procedure.
Why is the CyPass Micro-Stent Implanted in the Eye?
The FDA approved the CyPass Micro-Stent as a potential treatment for some patients diagnosed with primary open-angle glaucoma. The stent is implanted in the eye during cataract surgery to drain fluid from the eye. By allowing the fluid to drain, the stent helps lower the eye pressure. However, loss of cornea cells was observed in post-surgery follow-ups.
FDA Requires Additional Follow-ups
The FDA required the manufacturer to follow the patients in the clinical trial for a total of five years post-surgery. During the first two years after having the eye stent implanted, patients did not appear to suffer corneal cell loss at a different rate compared to patients who had cataract surgery alone.
However, within five years after surgery, patients with the CyPass Micro-Stent had lost more endothelial cells in the cornea compared to patients who did not have the stent implanted. Cataract surgery can lead to a slow loss of endothelial cells, but the patients with the implant appeared to have a higher loss of endothelial cells.
Endothelial cells are critical to eye health. The cells are part of the process of pumping fluid out of the cornea so that the cornea remains clear. These cells do not regenerate, and damage to these cells can result in loss of vision. Endothelial cells can be replaced, but it requires a partial corneal transplant.
Removal of the CyPass Micro-Stent from the Market
After the data was gathered from the five-year follow-up of patients with the eye stent, the device’s manufacturer decided to withdraw the device from the market. The CyPass Micro-Stents are not currently being used, but many patients still have the stents implanted in their eyes.
The company nor the FDA has recommended that the stents be removed as of this date. However, it is unknown whether some patients may have complications in the future.
If you have a CyPass Micro-Stent implanted in your eye, you can make an appointment with your ophthalmologist to assess whether you have experienced any endothelial cell loss. You can also discuss how to monitor cell loss and cornea health in the future. Following up with your ophthalmologist and keeping all future appointments is one of the best ways to monitor eye health and identify complications or injuries as soon as possible.
Contact a CyPass Micro-Stent Lawsuit Attorney for More Information
If you believe you have been injured because of the CyPass Micro-Stent, contact our office to discuss claims against the manufacturer for damages. Contact Attorney Fred Olinde of The Olinde Firm for a free consultation by calling (504) 587-1440 or 1-800-587-1889.