Confidentiality agreements can also make patients think twice before even talking about PAH with friends — let alone social media, an important forum for sharing such information, said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who directs the regulatory process for medical devices.
A supermodel is suing
In 2021, Ms. Evangelista, one of the most recognizable supermodels of the 1980s and 1990s, said she had gone into long isolation after developing PAH. She sued Zeltiq and announced last summer that she had settled with the company. Ms. Evangelista declined to comment on this article.
In the year it went public, the FDA received more than 1,100 reports of side effects from CoolSculpting treatments — more than in the entire previous decade. Last year, the agency received more than 1,900. A majority of all reports refer to hyperplasia.
Ms Kinard said the spike, which she says can be partially attributed to Ms Evangelista, “is alarming because the device has been around for many years”.
Ms. D’Addario, who reported her condition to the FDA, said that before she knew what PAH was, she would train constantly to lose the fat that had accumulated after CoolSculpting. Now, years later, she said, she understands it wasn’t her fault.
But the “mental trauma” of the mysterious ways her body became disfigured, and the months of not knowing what was happening remain with her, she said: “I’m struggling to this day.” Probably worse.”
Christina Jewett And Valeria Safronova reporting contributed.
Research contributed by Sheelagh McNeill, Kitty Bennett, Alain Delaqueriere, Kirsten Noyes And Jack Begg.
