Cold facts can today reveal that a preparation used for breast and butt augmentation in Sweden has injured several women. Even though doctors raised the alarm, the Swedish Medicines Agency has not stopped the preparation. Johanna Stensland is one of those affected. In the marketing it was stated that the filler was harmless, only local anesthesia was required. – When I was at the consultation, I asked what the risks look like. Then I got the answer that it is highly unusual and this is one of the safest things you can do, says Johanna Stensland. What she didn’t know, and what the clinic didn’t tell her either, was that a number of women in Sweden and in other countries had suffered complications. The product can clump inside the chest and create serious inflammation. The material can also migrate, i.e. move in the body and penetrate other body parts and organs. The preparation has been reported to Ivo and the Swedish Medicines Agency Johanna Stensland’s right breast swelled and turned red shortly after the procedure. Two years after the procedure, the breast ruptured and a white sticky fluid oozed out. The wound quickly turned into a large open hole. There was blood everywhere and she had to go to the hospital urgently. – I get a high fever in just a few minutes and my daughter, who was with me, gets really worried and thinks I’m going to die, says Johanna Stensland. About ten women and several doctors have reported the preparation Los Deline to the Health Care Inspectorate, IVO and to the Medical Products Agency. According to several researchers, the product is almost identical to PAAG fillers, which for decades have harmed thousands of women around the world. In Poland, Los Deline has been banned on the grounds that it is the same product, but the clinic that uses Los Deline here in Sweden claims that it is completely harmless. Ongoing investigation The Swedish Medicines Agency decided in November 2021 not to investigate the preparation. – We could of course have done a deeper investigation, but we have a responsibility to prioritize among all the other tens of thousands of reports about other products, says Helena Dzojic, unit manager for medical technology at the Medical Products Agency. A few days ago, Los Deline was suddenly stopped, when their CE certificate was temporarily withdrawn by the Turkish company that issued it. The Swedish Medicines Agency now has an ongoing investigation, but no decision on a ban has yet been made. In the player at the top of the article: See the interview with Johanna Stensland Here you can see the entire Cold Facts review on TV4 Play.
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