Madrid: A faulty substance used in eye operations has cost 13 Spaniards their sight in one eye and left 28 other patients also suffering injuries, health authorities announced Saturday.
Government medical agency AEMPS said in a statement that it was "aware of 41 cases of people affected by usage of the surgical product Ala Octa, which was recalled by the Spanish health ministry in June and is suspected of causing loss of vision in several people".
The agency said there had been 13 confirmed cases of patients being completely blinded in the eye that was being operated on using Ala Octa, which is made by German company Alamedics.
Other complications included damage to retinal tissue and the optic nerve, inflammations and a loss of sharpness of vision.
The 41 cases were reported at 11 health facilities in Spain, primarily in the Basque region on the French border, while Alamedics has pointed to a further case in Italy.
Christian Lingenfelder of Alamedics wrote to distributors on July 13 stating that "the product Ala Octa is suspected of being at the origin of degenerative processes in the retina".
"Sales have been stopped until the circumstances can be completely clarified," he added.
The Alamedics website describes Ala Octa as "chemically and physiologically inert and absolutely non-toxic".
The website describes the compound as a medical aid used in the treatment of several eye conditions, including detached retinas.
Spanish authorities announced a recall of Ala Octa on June 26, several days after a distributor raised the alarm over 20 suspect cases in the country.
"Samples were sent to a Spanish research institute specialised in ophthalmology for chemical and toxicological analysis," AEMPS said, adding that it was working with the pharmaceutical company and German authorities.
France also announced on September 23 that the product would be pulled from the shelves.
Spanish newspaper El Pais hit out at the drug company and at doctors, saying it had taken them too long to raise their concerns over the product.
The paper cited the testimony of Mikel Gonzalez, a 44-year-old from Renteria in the Basque region, who was blinded in his left eye by surgery on June 2.
Gonzales said his doctor had told him July "that one of the products had been revealed to be toxic and had caused atrophy of the optic nerve and damaged the retina".
AFP
