Justice will investigate the blindness caused by the medical product Ala Octa

2024-02-01 16:50:55

The State Attorney General’s Office has asked the National audience to investigate several German companies for manufacturing and marketing of the Ala Octa medical productapplied in retinal operations, and which produced loss of vision and other adverse effects in patients.

The product caused patients who were given adverse health effects such as amaurosis (a situation of non-perception of light in the operated eye), atrophy of the optic nerve (optic atrophy), necrosis retiniana and retinal vascular occlusion phenomena with possible sheathing of the retinal blood vessel wall.

It has been documented the existence of manufacturing deficiencies and deficiencies in the safety controls of raw materials and manufactured batches.

The product was used in 28 Spanish health centers with a total number of 125 reported cases.

Photo by Varvara Kurochkina.

It all started in 2016, when we learned the news that at least 32 personas they had stayed blind by an ophthalmological product, perfluorooctane, marketed under the brand name Ala Octa.

They entered the operating room for a retinal detachment and not only did they not cure it, but they remained blind. Forever.

The number of patients with sequelae was initially 32 people who As time went by it rose to 41. But later the severity of the case was multiplied by four. He Canary Islands University Hospital An exhaustive review of the retinal operations carried out with batches of the product was completed and the result raised the incidence on the Island from the eight cases revealed at the time to a total of 32.

What the Prosecutor’s Office now requests is that all centers that used the product report possible cases of damage.

All of them lost vision in the eye in which they underwent surgery, which in many cases is equivalent to total blindness during surgery of both or suffer some damage to the other eye.

Toxicological analyzes were carried out in the University Institute of Applied Ophthalmobiology (IOBA) of Valladolid. The lots were considered potentially cytotoxic for eye cells based on the differences observed in terms of degeneration and cell death with respect to the controls used.

To the very high percentage of negative results in Spain are added those of France, Belgium or Germanywhere these damages were also detected.

The tip of the iceberg of this problem had already appeared before. In 2013, both in Spain and in Chilecases resulting in loss of vision in patients who underwent retinal surgery in which it was used perfluorooctano (then it was marketed under another brand).

In fact, in September 2013, the Spanish Medicines Agency itself alerted about four incidents in a center in Navarra related to the product Meroctane made by Meran Türkiye.

In it seven cases were reported in the American country. But perfluoroctane returned to the hospitals Spanish, both public and private, months later, under the brand Octa Wing from the German manufacturer Alamedics.

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