Photo/IllutrationMisty Holliman reads a book to her children. (Can Turkyilmaz)

  • Photo/Illustraion

People around the world are suffering painful and potentially life-threatening effects from implants of defective medical equipment, unaware the devices were banned or recalled in other countries, an international survey has found.

The problem is that information on problems with such medical devices is not shared sufficiently across borders, according to the survey conducted by the International Consortium of Investigative Journalists (ICIJ), a Washington-based nonprofit media organization.

The ICIJ said the problem could expand because demand for such medical devices is rising in aging populations around the world and companies are continuing to rush to get their products on the market.

The ICIJ has cooperative relations with 59 media organizations in 36 countries, including The Asahi Shimbun.

The 59 organizations made more than 1,500 information disclosure requests and obtained more than 8 million records. More than 70,000 records obtained from 10 countries, including the United States, Australia, Canada, India, Spain, Mexico and Finland, concerned recall information or safety warnings about the medical devices.

The ICIJ has compiled the information into a database, the first in a series. Records from Japan will be added later.

ARTIFICIAL HIP JOINT SCRAPES BONE

The ICIJ is still analyzing the data, but it has already found one victim who was victimized by the lack of information sharing.

“A defective hip joint is still buried in my body,” said Jeong Sang-ho, 47, a former staff member of a garbage disposal facility in South Korea.

In July 2008, his thigh bone was found to have become necrotic, so he underwent surgery to install a metal artificial hip joint manufactured by a subsidiary of U.S.-based pharmaceutical and medical equipment company Johnson & Johnson (J&J).

About one-and-a-half years after the operation, he began to feel intermittent pain in his right leg.

“It felt as if a needle was always stabbing my leg,” he said.

A medical check found that the artificial hip joint had broken and was scraping against his thigh bone.

Sales of that and other artificial hip joints produced by the manufacturer were banned by the Australian government in December 2009 because the number of patients who received those joints and complained of bad physical conditions was larger than expected.

However, the information was apparently not shared, and Jeong was not informed of Australia’s ban. In August 2010, he underwent another operation to replace the broken artificial joint. But the replacement hip joint was also on Australia’s list of banned products.

Twelve days after the re-surgery, the manufacturer announced a global recall of those artificial hip joints.

Jeong received $600 (about 68,000 yen) in compensation from J&J.

But his pain remained, and it became difficult for him to work long hours. He eventually lost his job and now cannot even lift an infant in his arms.

The artificial hip joint is still in his body although it is subject to the recall.

He and other patients filed a lawsuit in the United States against the manufacturer, demanding compensation.

J&J told the ICIJ that it refrains from commenting about individual patients out of respect for their privacy. But the company said that the artificial hip joints that Jeong received are not sold in Japan.

In addition to requesting information disclosure from various governments around the world, the ICIJ interviewed more than 200 patients and companies.

It confirmed another case involving different medical equipment.

Misty Holliman, a 26-year-old mother of four children in Texas, told reporters that she has been troubled by pain in her pelvis and extreme fatigue.

In May this year, she underwent surgery to install a metal, coil-shaped intrauterine contraceptive device (IUCD), manufactured by a German pharmaceutical and medical equipment company.

However, reports had surfaced around the world that the device created holes in the womb and uterine tubes. In the worst-case scenario, the entire womb must be removed.

The German manufacturer suspended sales of the device in Europe in September 2017. But eight months later, Holliman underwent the IUCD operation.

In July, two months after her surgery, the German company announced it would suspend sales of the IUCD in the United States by the end of this year.

Holliman told the ICIJ that she had not been told by her doctors about the sales suspension in Europe before her surgery.

She said her daily life is now filled with anxiety and pain.

COUNTRIES WITH NO REGULATION INSTITUTIONS

Global sales of medical equipment have increased and are estimated to reach about $400 billion this year.

The increase is partly attributable to aging populations throughout the world and the rise in diseases such as heart ailments and cerebral strokes.

The medical equipment can improve the quality of life of these patients, but defects could lead to serious disabilities and even death.

In the same way as medicine, companies must obtain approval from governments or other authorities to sell medical equipment.

However, regulation criteria are said to be looser in Europe than in Japan or the United States. Therefore, many companies first seek approval in Europe to put their products on the market as early as possible.

In Africa and some other regions, many countries do not even have their own regulation institutions for medical equipment. Instead, they use approval given by European countries or the United States.

Information about problems with such medical equipment used throughout the world is not easily conveyed, resulting in the same medical accidents occurring in different countries, according to the survey.

To prevent such accidents, the ICIJ is gathering information about those problems and revealing them as early as possible.

The information is available at the ICIJ’s website (https://medicaldevices.icij.org).

(This article was compiled from reports by Kenta Iijima, Rihito Karube and Kenji Tamura, a senior staff writer.)