ICIJ's Asian partners met up in Seoul, before publication.
ICIJ's Asian partners

ASIAN REPORTING

Implant Files in Asia: Regulation and transparency on medical devices remains patchy while patients suffer

On a stormy Seoul morning in early October, local reporters met with visiting journalists from Tokyo, New Delhi, Islamabad, Beijing, Stockholm, New York and Washington D.C. at a quiet cafe.

The group had snuck away from a journalism conference to discuss the final details of the Implant Files, a global investigation into the medical device industry.

With just two months to go ‘till publication, ICIJ partners shared newly-uncovered incident data from Korea, leads on overtreatment allegations in Pakistan and the harrowing accounts of Japanese patients suffering the side effects of gel fillers.

The reporters interrogated the international relevance of their findings on faulty stents, breast implants and other medical devices.

Their stories, which began appearing on November 26 (Asia time), helped to paint a complex international picture of the $400 billion industry and regulatory oversight of it.

Japanese Olympus fined $85 million

Japanese news agency Kyodo News reported that some endoscopes manufactured by Olympus caused bacterial infections in about 190 patients in Europe and the U.S. between 2012 and 2015.

Executives of the Tokyo-based company allegedly knew about infection risks but failed to warn U.S. authorities, according to court records cited in the report. (The product was never sold in Japan.)

On Monday, a U.S. Federal judge ordered Olympus pay an $85 million fine for failing to report infections connected to its endoscopes. As part of a plea deal with the Justice Department, the company and a former executive also pled guilty to continuing to sell the products in the U.S.

The Japanese reporters also found that patients who got gel filler injections in breast-augmentation surgeries had been reporting complications including lumps and suspicious tumors.

Unlike in Japan, gel fillers are banned in the U.S. and France, and experts have criticized the procedure in neighboring South Korea, the Asahi Shimbun reported.

Chart 1: Adverse events reported to US regulator. Data analysis by ICIJ, analyzed by ICIJ. Chart 2: Adverse events reported to the Japanese regulator from 2008 to 2017.

In the past decade, about 90,000 incidents were reported to Japan’s health ministry as potentially linked to medical devices, an ICIJ analysis of ministry data shows. Coronary stents were responsible for most of the adverse events.

Device incidents found in Korea

In South Korea, where the government doesn’t disclose detailed adverse event data, Newstapa reporters found that nearly 4,900 incidents were reported as caused by devices over the past four years. Most reports were related to silicone breast implants.

Newstapa also reported that often patients were not informed about the potential risks associated with an implant before undergoing surgery, nor were they notified when their product was recalled.

Medical device companies were also found to finance South Korean doctors’ trips and attendance at medical conferences. Every year they pay an estimated $2.4 million to doctors through dozens of overseas academic conferences. Manufacturers don’t pay physicians directly, according to Newstapa. Instead, they cover the operating expenses of the company that organizes the conference so the link between the manufacturer and the physician remains secret, the report said.

A public hospital in New Delhi, India.
New Delhi hospital

Payment to doctors and weak rules in India

In India, authorities are currently examining the tax-exempt status of such payments, as well as gifts, training fees and trips to conferences for doctors provided by pharmaceutical and device makers.

An Indian Express investigation found that, over the last decade, multinationals such as Abbott Laboratories, Medtronic and Johnson & Johnson were flagged by the Indian government for allegedly claiming such expenses as tax-deductible “invention”, “advertisement”, “publicity”, “propaganda” and “customer relationship” items. Courts are still debating whether restrictions on such tax benefits apply only to physicians or to companies too.

India has yet to enact a Medical Device Regulation Bill that was drafted in 2006. In 2016, the government issued a set of rules on design and manufacturing requirements, saying stronger legislation would “curtail competition.” Experts and industry insiders interviewed by the Indian Express described the new rules “as an easy way out for politicians of the day.”

Indian patients are seldom informed about device safety issues or potential risks. The Indian government has published recalls for just 23 devices, despite data from U.S. regulators showing three times that a number of devices sold into India were recalled overseas between 2016 and 2017 over serious safety concerns.

The Implant Files, the Indian Express said, “exposed how almost every medical device is advertised, sold, and surgically implanted under regulatory systems that, effectively, don’t exist.”

 

India began requiring hospitals to report adverse events only in 2014, according to previously undisclosed information obtained by the Indian Express. Most of the incidents reported so far — about 900, more than half of them this year — were associated with stents, orthopedic implants, and intrauterine devices.

Patient’s ‘eventual casualties’ in Pakistan

On the other side of the northern border, in Pakistan, no regulatory body checks the safety of medical devices that are imported from the U.S., Canada, Australia, and Europe, ICIJ’s media partner, The News, reported.

After a scandal over unregistered stents, in January this year, Pakistan’s Supreme Court began requiring the licensing of device importers and their registration with the regulatory agency. Yet, the government doesn’t require hospitals to report incidents caused by implants, a task that is left to device distributors and manufacturers, with poor results.

Despite recent inquiries by the National Investigation Agency that have shed light on the health risks of corruption, abuse of stents by unscrupulous doctors continues. One patient interviewed by the Pakistani outlet described how he became sick after an interventional cardiologist implanted a stent which was later deemed unnecessary. Another patient died after a stent caused a blood clot.

The News report concluded: “As records of adverse events are not kept, and the investigation of such occurrences is not carried out by the hospital in absence of a strong regulator, the patients are eventual casualties.”