Implant Files

The US agency wants stakeholders to chime in on what information should be included in product labels to notify patients about potential side-effects of medical device materials, without being too burdensome for manufacturers.

Bayer launches multi-year campaign “Outsideologist Project” for Claritin to offer parents fun ways to get their children outside. GSK’s “Change the Game” campaign for Flonase as official allergy relief partner of MLB has new spokesman.

National Center for Health Research president Diana Zuckerman is concerned about a new joint notice from the US HHS and the FDA designed to deregulate a slew of devices and tests.

As expected based on retrospective data, new results from an ongoing postmarket study has found Bayer’s Essure birth control device has significantly higher rates of major adverse events compared to women who undergo tubal ligation.

While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.

Following closely on the heels of a medical device tax repeal win, AdvaMed CEO Scott Whitaker sat down with Medtech Insight to discuss how the industry advocacy group ended the Obamacare excise tax and what it has in store for 2020.

The Therapeutic Goods Administration says it now has enough evidence to warrant cancelling, suspending and recalling a number of textured breast implants because of the potential risks of developing anaplastic large cell lymphoma.

March 2019 was a busy month in terms of news for those preparing for the implementation of the MDR and IVDR, while Brexit negotiations spiraled into a new level of madness.

Passing the half-way mark in the transition period to full implementation of the EU's new Medical Device Regulation (MDR) seems to have focused the attention of readers back onto technical regulatory issues.

Weeks after the "Implant Files" journalistic investigation of the device industry was released, EU industry advocate Serge Bernasconi described the results as "unhelpful" and "imbalanced." But might they also be disruptive, threatening the smooth rollout of new EU regulations? We put this and other questions to Bernasconi, chief executive of the EU's largest medtech trade association, MedTech Europe.

With increased pressure on US FDA surrounding its approach to safety and growing concerns with Bayer's Essure birth control device, the agency is now requiring the manufacturer to extend a mandated post-market study of women who have been implanted with the product, among other requirements.

The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.

Europe's biggest medtech industry and market, Germany, was in the crosshairs of the "Implant Files" and its ICIJ reporters, and predictably it caused a major stir. The episode has been a wake-up call for medtech, but industry hasn't let it develop into the crisis it briefly threatened to become, and is now looking beyond it and to the commercial challenges of 2019.

Investigative journalists, tort lawyers, the judicial system and public opinion all provide checks and balances on medical research, industrial innovation and commercial exploitation of health-care technologies. Whether those affected like it or not, these well-intentioned elements of society demand accountability of an industry that has a profound effect on all our lives. The "Implant Files" episode is a reminder for medtech stakeholders across the world that nothing can be taken for granted, says medtech industry and regulatory consultant Trevor Lewis in this guest column for Medtech Insight.

The International Consortium of Investigative Journalists started publishing the findings of its "Implant Files" investigation last month, but the two main industry groups in the US have not picked up any significant political backlash resulting from the reporting so far.

The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.

The Canadian government wants to strengthen its oversight of medical devices, both on the pre-market and post-market sides, partially in response to recent Canadian news reports on safety issues with implantable devices, the country's health minister says.

The Facebook group Essure Problems has sprouted a spin-off, Medical Device Problems, that attempts to serve as a central resource for patients who say they were injured by medical devices. Medtech Insight spoke to two leaders in the group about their ongoing advocacy efforts and the Medical Device Safety Act, and what they think about the "Implant Files" investigative reports that have embarrassed industry.

Nov. 25 was the halfway mark in the three-year transition toward full implementation of the new EU Medical Devices Regulation. It was also the day the International Consortium of Investigative Journalists (ICIJ) dropped a bomb on the medical device sector, and it has been shelling the industry every day since. How are key industry experts reacting?

In the context of a global investigation of the device industry and a change in power in the US House, health-policy experts say oversight by Congress of FDA's regulation of devices in 2019 is likely to swing incrementally away from ensuring innovation of products and easy market access, toward greater assurance of product safety before devices reach the market.