The Implant Files articles were produced in coordination with an international investigation spearheaded by the International Consortium of Investigative Journalists (ICIJ). A few years ago, this same consortium launched the Panama Papers investigation. The goal of the Implant Files investigation was to expose various issues within the medical devices industry. Inkyfada covered the Tunisian component of this global investigation, which brought together more than 250 journalists across nearly 30 countries.
The three articles in this series present problems related to the global medical devices industry as well as those related to Tunisia’s local industry. The article \”Implant Files: The Invisible Dangers of Medical Devices\” shows the impact of faulty medical devices on an international scale — more than 80,000 people worldwide have died and nearly 2 million have been wounded from certain medical devices.
The second article, \”Implant Files: Medical Devices in Tunisia and the Flaws of a Global System,\” focuses on issues related to the control of medical devices in general and addresses the faults of the Tunisian system in particular. Strict regulations should protect patients’ health; however, patients are often the last to be informed about risks associated with medical devices.
The third article, \”Implant Files: The Downplayed Risks of Breast Implants and Medical Tourism,\” describes the risks related to medical tourism, a growing industry in Tunisia. In recent years, many scandals related to breast implants have come to light, yet several risky models continue to be used in Tunisia, without patients being properly informed of their risks. As medical tourism in Tunisia grows, it is increasingly difficult to integrate proper medical monitoring as well as accountability systems, should problems arise.
This investigation aims to inform the Tunisian public and facilitate greater regulation of this industry. In Tunisia, as in many other countries, the regulation of medical devices is weaker than that of pharmaceuticals. In addition to publishing these articles, we have also launched a public appeal for information. Any patient, doctor, or person with a connection to a medical institution can contact us to provide information about faulty devices. We also created a search engine on the Inkyfada website. It lists all medical devices potentially available in Tunisia that the FDA (Food and Drugs Administration) has previously flagged in a centralized database. This search engine complements the one created by the ICIJ but is designed with the Tunisian audience in mind.
What makes this project innovative?
As part of an international collaboration, this project has a global reach. The theme that links these investigations is also innovative; unlike pharmaceuticals, medical devices have been the subject of little analysis. In Tunisia, this project is innovative for several reasons. By creating a database that centralizes all of the potentially risky medical devices in Tunisia and by pairing it with a search engine, we facilitated access to all Tunisians interested in understanding otherwise opaque information. To this end, our developers created a user-friendly interface that presents the exact reference number of each product, the problems associated with it, and the decision that the FDA made with regard to each product. In addition to the search engine tool, these investigations feature testimonials and exclusive interviews as well as illustrations and infographics that help the reader understand the complicated medical devices industry.
What was the impact of your project? How did you measure it?
The Implant Files investigation was designed to make an international impact. Thanks to the ICIJ, this investigation made waves around the world. Our article on breast implants was translated into English and featured on the ICIJ’s website. In Tunisia, the investigation’s primary goal was to educate the public about the medical devices system, which is poorly understood and difficult to navigate. Thanks to the Inkyfada team, all flagged medical devices that have the potential to be marketed in Tunisia can be found in a single, user-friendly database. Additionally, the Implant Files texts are published in both Arabic and French to extend the information’s reach, both in Tunisian and abroad. The search engine created by Inkyfada is particularly effective due to its user interface, which clearly organizes and presents the data. Given the mass of data and the lack of a centralized database provided by the state, the Inkyfada team standardized the names of medical devices, created category and subcategory systems, and translated descriptions into French. The developers then integrated this data into an interactive and intuitive interface. The final product provides readers with a simple search tool that allows them to learn more about specific medical devices; it also provides a way for readers to submit testimonials, which support our investigations.
Source and methodology
As part of the partnership with the ICIJ, Inkyfada gained access to the entire FDA recall database. Our journalists then identified which devices had the potential to be exported to Tunisia: more than 900 devices, classified into several categories. Next, our team looked into which devices from this list were actually distributed in Tunisia. We contacted representatives of foreign suppliers and verified which devices were marketed in the Tunisian market by checking each serial number and batch number, as well as product distribution dates. Once this sorting was done, we translated the products descriptions and reasons for recall into French to facilitate comprehension for our readers. There also exist several Tunisian institutions that are tasked with handling recalls of defective devices: The Central Pharmacy, the Directorate of Pharmacy and Medicine (DPM) and the ANCSEP (National Agency for the Control of Health and Environmental Products). The data provided by these institutions’ websites are poorly organized and lack critical information. To integrate their data into our investigation and obtain more information, our team submitted formal requests for access to information. As a result, we were able to add some locally-produced devices to our database; we also wrote an article about these organizations’ lack of transparency.
To have a usable data set, we extracted information available on 2 different websites: the Directorate of Pharmacy and Medicine (DPM) and the Central Pharmacy. These two sources offer different data about medical devices or drugs that have been recalled from the market. Posing a challenge to our developers, the data from the DPM website is not formatted or presented in a table. Information is in lines, which include a date (multiple lines may have the same date), serial number(s), product name(s), firm, country, and type of recall. Given the number of possibilities, we developed code that scans the HTML formatting. We singled out the word "laboratoire" to extract the names of labs. For serial numbers, we looked at the characters that follow them; if it is a ”,” that means that there are several lot numbers. We stopped once we reached the word “AND.” Because the DPM had recently changed its site — the ancient pages didn’t have the same formatting as the more recent pages — we had to adapt the code accordingly. For the Central pharmacy’s database, we found it easier to analyze the data set manually rather than writing code to extract the data. Before finalizing our data charts, we manually verified our information. We also manually researched individual products so as to be able to differentiate the products. The table we constructed from this data contains the following information: year, serial numbers, product, laboratory, and country. Inkylab developers used the JQuery DataTables in server-side to create the search engine for this database. Once a user begins searching through the database, the DataTable sends a request to the server for processing. The developers also used PHP to create a controller that handles received requests. The articles were integrated into the website thanks to Inkylab’s inku.be platform. This platform allows journalists to autonomously integrate interactive multimedia components (videos, innovative graphics, etc.).
Malek Khadhraoui - Publishing Director Monia Ben Hamadi - Editor-in-Chief Hanene Zbiss - Journalist Haifa Mzalouat - Journalist Hortense Lac - Journalist Chayma Mehdi - Technical Direction Houssem El Manaa - Developer Marwen Ben Mustapha - Graphic Designer