Doctors blame media for scaring patients off vaginal mesh implants

The Guardian, 6 October 2017
Author: Melissa Davey
“Inaccurate media reporting about vaginal mesh implants and the lawsuits associated with them has caused patients to become fearful of mesh procedures that may be essential to improving their health, New Zealand general surgeon Dr Steven Kelly says.”
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Vaginal mesh scandal: women don’t need body-shaming on top of their pain

The Guardian, 1 October 2017
Author: Barbara Ellen
“The ongoing vaginal mesh implant scandal is a complex affair, with group lawsuits erupting all around the world, including the US, the UK and Australia. Last week, Johnson & Johnson’s Ethicon unit was ordered to pay a record $57m in damages to a woman called Ella Ebaugh. The J&J implant, launched without a clinical trial, is still marketed, often in cases involving traumatic births, years after it was known to cause appalling problems to women such as Ebaugh, including intense pelvic pain and torn bladders and vaginas, leading to agonising sex and incontinence.”
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Direct-to-Consumer Medical Testing in the Era of Value-Based Care

JAMA. 2017; 317(24): 2485-2486.
Author: Kimberly Lovett Rockwell
“This Viewpoint documents the growing market share of direct-to-consumer (DTC) medical testing despite growing recognition that it represents low-value or harmful care and proposes policy options to increase accountability and protect patients from adverse consequences of DTC testing.”
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Medical devices face tougher premarket testing under new EU laws

BMJ 2017; 357: j1870
Author: Deborah Cohen
“The European Parliament has passed new legislation to tighten regulation of medical devices that will require high risk devices, such as hip implants, to undergo more premarket testing and assessment. European device regulation has come in for criticism after a series of high profile failures—including hip replacements, breast implants, and pelvic meshes—that have resulted in harm to patients.”
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Smart homes, private homes? An empirical study of technology researchers’ perceptions of ethical issues in developing smart-home health technologies

BMC Medical Ethics 2017 18:23
Authors: Giles Birchley, Richard Huxtable, Madeleine Murtagh, Ruud ter Meulen, Peter Flach, Rachael Gooberman-Hill
“Smart-home technologies, comprising environmental sensors, wearables and video are attracting interest in home healthcare delivery. Development of such technology is usually justified on the basis of the technology’s potential to increase the autonomy of people living with long-term conditions. Studies of the ethics of smart-homes raise concerns about privacy, consent, social isolation and equity of access. Few studies have investigated the ethical perspectives of smart-home engineers themselves. By exploring the views of engineering researchers in a large smart-home project, we sought to contribute to dialogue between ethics and the engineering community.”
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Weak Reporting System Let Risky Surgical Device Stay in Use

NYT Health, 8 February 2017
Author: Denise Grady
“Doctors and hospitals failed to tell the Food and Drug Administration about cases in which cancer was spread around inside women’s bodies by a surgical tool used to operate on the uterus, according to a report issued on Wednesday by the Government Accountability Office.”
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Remote monitoring of medical devices in Australia

Med J Aust 2017; 206 (2): 62-63
Authors: Bradley Wilsmore, James Leitch
“The collection, storage and distribution of remote monitoring information by industry are not clearly regulated. Regulation is complex, given all current industry providers have offshore servers and local distribution of data. While some companies have adopted a worldwide information security management system standard (ISO 27001), regulation has been company dependent and the current system is largely self-regulated by industry at the local level. This raises further issues and may exacerbate the potential for a conflict of interest regarding industry involvement.”
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Thousands of pacemakers and defibrillators ‘at risk of hacking’

SMH, 6 February 2017
Author: Julia Medew
“Thousands of Australians with pacemakers and defibrillators in their hearts are at risk of cyber security breaches that could allow somebody to kill them, doctors say. Some cardiologists are also concerned that the multi-billion dollar medical device industry has too much control over devices being implanted in Australians, and that this could lead to over-servicing to boost profits.”
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