My FDA-approved Buckle: A Regulated Intervention

Michele Battle-Fisher calls for deeper ethical scrutiny of unregulated and experimental medical interventions.

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I have a right eye that resembles a colander. Years ago, my retina peeled away from the back of my eye. This condition is called a rhegmatogenous retinal detachment. Because of this, I would see floaters that looked like annoying swarms of gnats. The retina is the light-sensitive layer of tissue that lines the inside of the eye and sends visual messages through the optic nerve to the brain. If not treated quickly, retinal detachments can cause permanent vision damage.

My condition led to multiple surgeries and laser treatments to reattach my retina, the insertion of an artificial lens, and lasers to close the retinal tears. One of my surgeries involved the insertion of a “buckle,” which consists of a piece of silicone sponge, rubber, or semi-hard plastic placed on the outside of the white of the eye. This buckle flattens the retina. At the time of this surgery, I was in my 30’s. Medically, this surgery was quite unexpected since the retinal detachment was not due to trauma.

Since I did not get the detachment treated quickly, I was prepared for the possibility that I would not regain my full sight. My doctor never promised me that a buckle would be a perfect cure. However, I chose this surgery that my doctor could do in his sleep. Under the U.S. Food and Drug Administration (FDA) Article 21 Code of Regulations, ophthalmic devices are covered under Subchapter H, under the oversight of “Medical Devices.” I underwent buckle surgery with a medical device covered by §886.3300. My ophthalmologist proposed this surgery as the most viable option for restoring my vision. The FDA regulation supports the view that this buckle surgery gives patients with my retinal condition the best chance of recovering their sight.

Image Description: Brown eye with light reflecting on right side of iris.

Although I took some risks when undergoing my buckle surgery, I often wonder, what would have happened if I had chosen a different treatment for augmenting my vision? I wonder what may have happened if I had chosen an unregulated or experimental intervention, such as adipose stem cell therapy.

In a recent case report published in New England Journal of Medicine, three women who suffered from macular degeneration underwent experimental surgeries to restore their profound vision loss. The women all presented with some vision in the unaffected eye and were injected with adipose (fat) stem cells into the whites of the eyes by a clinic in the United States. The clinic used fat extracted by liposuction. Both eyes of the women were injected. After a year, the patients experienced zero light perception. In the end, all three patients were legally blind in both eyes. These cases illustrate that even at establishments that present themselves as clinics, a procedure that is unproven and not under FDA oversight may lead to unforeseen, adverse results that worsen morbidity and mortality.

Many patients are desperate for a cure or treatment and must make quick decisions. In my case, I had consultations before the surgeries, but I did not have a lot of time to waste. Under such time constraints, patients may be quick to accept recommendations regarding unregulated and experimental interventions, especially if they trust their providers. Understandably, this stem cell intervention offered these patient hope that their sight would be restored. Patients have the right to make educated choices, but it must not be lost that many treatment decisions are often made under pressures and constraints. Having the faculty to discern misconceptions about the chance of success requires ethical and clinical transparency in the medical intervention.

Adipose stem cell treatment, like many unregulated and experimental interventions, would most likely not be on a patient’s radars unless it is proposed or “advertised” by medical professionals or clinics.  Healthcare professionals have an ethical obligation to be transparent about whether interventions are unregulated or experimental and they must disclose all risks to patients.  Medicine must be on high alert because unregulated clinics are a minefield where profit can prevail over accountability, safety, and ethical care.

For me, the FDA-approved buckle surgery saved my impaired eye. Although I constantly fear loss of my one remaining good eye (which is still rather myopic),  I am grateful to my ophthalmologist who increased my chances of keeping as much sight as possible. Moreover,  I am relieved that I did not pursue unregulated or experimental interventions that could have caused me to lose my sight altogether.

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Michele Battle-Fisher is an Adjunct Assistant Professor at Wright State University Boonshoft School of Medicine. @battle_fisher