Just How Rare Is a ‘Rare' Side Effect of a Fat-Zapping Procedure?

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New York Times investigation found that popular beauty treatments may cause disfigurement in more patients than was previously thought.

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Anna Kode was a New York Times fellow and a reporter in the Real Estate section. She began researching CoolSculpting over a year before. She spent many months reading documents, talking to experts and interviewing doctors and patients.

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Ethan Hauser approached me in early 2022 with a question. Neither of us realized that it would turn into a reporting project lasting a full year. The model Linda Evangelista had revealed publicly a few months earlier that she was disfigured as a result of CoolSculpting. This cosmetic treatment promises to remove fat cells.

P.A.H.

Ethan's initial question was simple: If the side effect is as rare as estimated by the company, wouldn't it be strange that a supermodel of renown got it? The answer was far from simple.

Many publications have covered the story of Ms. Evangelista. We wanted to dig deeper. We combed through Securities and Exchange Commission documents and spoke with dozens doctors and patients. After more than a full year of reporting on CoolSculpting, we finally published our findings last week. Our reporting shows that P.A.H. Our reporting indicates that the risk of P.A.H.

I admit I didn't know where to begin with this project. I was a Styles desk reporting fellow, and had little experience in long-term investigative journalism. It was a great opportunity to get out of my comfort zone and finally use my degree in information science. My fluency in numbers would be useful.

Kirsten Danis approached Ethan and me shortly after we started researching CoolSculpting. She wanted to know how she could assist. She taught me the basics of investigative reporting. One of her favorites is'smile, dial', which she may have borrowed from telemarketing.

I started by calling experts who are familiar with the F.D.A. The regulatory process. I wanted to understand the regulatory process.

I then spent several months researching all documents that I could find about CoolSculpting. These included earnings reports, lawsuits, and medical studies. I looked for information that would surprise readers. In 2011, I discovered from a S.E.C. I learned from a 2011 S.E.C. The study that was used to clear CoolSculpting involved only 60 patients. This was not unusual, as clinical studies for medical devices tend to be small. However, readers who are unfamiliar with the world of medical devices may find the size of this study interesting.

The lawsuits brought against the CoolSculpting manufacturer were another source of information. Reading court transcripts and other documents taught me a lot. I also used the F.D.A. The Manufacturer and User Facility Experience Database is a great resource for finding patient, physician and manufacturers reports on P.A.H.

The Times' research team helped me find the individuals who wrote the correspondences. I learned many technical terms, and how they differ. For instance, approval and clearance are two separate processes at the F.D.A. with approval being the more rigorous. I would mute the computer notifications, print out the documents, and highlight each line.

More than a dozen physicians I spoke to said that the manufacturer's risk estimate was lower than the actual risk they observed. Allergan declined to comment on most of my questions when I contacted them for a response. Allergan has stated that P.A.H. Allergan has stated that P.A.H.

In order to humanize the article I included voices and experiences from patients. It is one thing to learn about P.A.H. It's one thing to read about P.A.H. Ms. Evangelista wrote, for instance, on Instagram that her condition had made her a'recluse.'

Some people were afraid to speak out because they hoped the company would pay for corrective surgery. These payments were often conditional on patients signing confidentiality agreements. Gina D'Addario was one of the women that I spoke to. She had rejected the settlement offer from the company. She shared her story in the hopes that others would benefit from it.

Patients I met through Facebook groups of people with P.A.H. were connected to me by doctors who performed corrective surgery. I did not want anyone to feel pressured into participating in the article. I also tried to make sure those who spoke out felt heard.

My first major Times investigation didn't involve meeting sources late at night in parking garages or listening to important conversations on trains. The process involved reading documents over and over, as well as speaking to dozens of people that had witnessed or experienced P.A.H. firsthand.