The Swedish Medicines Agency is now acting to completely stop filler injections for breast and butt augmentation. The reason is the complications that have arisen in people who have been treated with the preparations.
– If we focus on the individual products, we will always be one step behind, says Helena Dzojic, unit manager for medical technology at the Medical Products Agency.
Earlier this year, Kalla Fakta revealed how a number of women suffered serious complications such as leakage and severe infections after the agent Los Deline was injected into the buttocks and breasts.
Recently, Los Deline was stopped from the European market as it was considered that the risks of the product overshadowed the benefits.
After investigating Los Deline, the Swedish Medicines Agency concluded that all types of injected body fillers entail major risks. They are now collaborating with the corresponding authorities in other EU countries to take a greater approach and review the entire product group.
– At the Swedish Medicines Agency, we saw during the investigation that it is not enough to just look at the individual products, but we have to see what we can do further, together with other national authorities, says Helena Dzojic, unit manager for medical technology at the Swedish Medicines Agency.
Discontinued products change name
Over the years, Los Deline has been on the market under a number of different names. It has been noticed that when a product is discontinued, it is relaunched with a new name.
– It would not surprise me if there are more products of this kind on the market, says Helena Dzojic.
When the investigation into a new set of regulations can be completed is still unclear. But Helena Dzojic believes that it can contribute to clarity in the industry in the long term.
– Even if it would take a little longer than pursuing an individual case, we win in the long run.