Carrera hacia el fondo: La investigación revela el costo de las leyes débiles sobre dispositivos médicos

Vicki Kelly, a 69-year-old Victorian mother of three, was looking forward to spending her time relaxing on a cruise ship's sunlit deck, sipping a pink drink with an umbrella. Instead, she has spent 17 months in hospital, paralyzed from the waist down following complications from a medical pump implanted to treat her back pain. The device, which cost a fortune, led to a blood clot that blocked a spinal cord artery. Her doctor described the incident as catastrophic, claiming it was unprecedented. Kelly, unable to move or even get herself out of bed, expresses frustration over the lack of transparency regarding the cause of her condition. She doubts the claim that such an occurrence is one in a million and fears the device might fail again, endangering others. More than 150,000 medical device-related incidents requiring hospitalization occur annually in Australia, according to the Australian Institute of Health and Welfare. The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, does not disclose the number of injury or death reports it receives yearly. An investigative effort by this publication and 60 Minutes uncovered over 81,000 government logs detailing device side effects, recalls, and hazard alerts. The team interviewed over 70 individuals, including patients, doctors, researchers, TGA staff, and industry consultants, while reviewing legal cases and coroner reports. Internal regulator documents were also obtained. Data analysis revealed a consistent rise in deaths, injuries, and adverse event reports. The investigation uncovered critical flaws in the TGA’s database, with numerous fatalities prior to October 2019 remaining unrecorded. After inquiries from this publication, the TGA issued a notice about a “technical issue” affecting its database. The findings exposed a regulatory process where only a small fraction, just 4.3 percent, of the 55,223 devices approved since 2016 underwent thorough scrutiny. Over the past decade, only 830 devices were rejected. Medical devices in Australia can receive approval without human trials. Over 85 percent of devices rely on European certification from for-profit notified bodies, rather than direct oversight by a regulatory body. A confidential TGA source described this practice as a “race to the bottom,” suggesting that manufacturers could choose the most lenient certifying entity. This approach allows for faster product registration but increases the likelihood of recalls or safety alerts compared to U.S.-approved devices. A 2016 study in the British Medical Journal found that devices certified via European routes were 2.9 times more likely to face recalls or warnings than those approved by the FDA. When devices begin causing harm, the TGA faces challenges in identifying issues due to outdated technology and occasional staffing shortages, as revealed by freedom-of-information disclosures. Wendy Bonython, an associate professor at Bond University specializing in medical device regulation, noted that the regulatory framework has historically been less rigorous than drug regulation. She highlighted a long-standing pattern where faulty devices often bypass scrutiny. Internal communications from the TGA have raised alarms among staff. Screenshots from an online briefing in November, acquired by this publication, showed employees expressing concerns about industry influence, non-compliance, and the regulator’s effectiveness. One TGA employee questioned whether the organization was fulfilling its duty as a regulator or had become complicit in overlooking its responsibilities. Another lamented that the agency appeared to prioritize industry interests over public health. The pump in question, a Medtro model, became the focal point of Kelly’s ordeal. Its failure underscores broader systemic vulnerabilities within Australia’s medical device oversight. As investigations continue, the implications extend beyond individual cases, highlighting urgent gaps in regulatory practices that demand reform.