Introduction

Webcast archive: The pelvic mesh, medical device failures, and AS/E

This week, we discuss the use of women as "guinea pigs" in the healthcare system (especially for contraceptives), and the resulting side effects driving them to seek euthanasia.

Webcast archive: The pelvic mesh, medical device failures, and AS/E

In this episode of Euthanasia & Disability, Amy Hasbrouck and Taylor Hyatt discuss:

  • The pelvic mesh, medical device failures, and AS/E
  • Britain’s Royal College of Physicians goes neutral on AS/E … sort of

Please note that this text is only a script and that our webcast contains additional commentary.

THE PELVIC MESH, MEDICAL DEVICE FAILURES AND AS/E

  • In January we heard a news report on Radio Canada that mentioned an unnamed woman who applied for euthanasia due to pain caused by a pelvic mesh she’d had implanted to control stress urinary incontinence (SUI).  The story focused on a study published in the Journal of the American Medical Association (JAMA) Surgery showing higher rates of depression in women who had surgery for complications from the pelvic mesh devices.
  • Though we weren’t able to find any more information about the unnamed woman, we have learned a lot about the problems caused by the pelvic mesh, how hard it is to get help when something goes wrong, the surprisingly lax approval process, the lack of informed consent, and how the pelvic mesh is just the tip of the iceberg in terms of medical device failures.
  • For more than 20 years, companies such as Johnson & Johnson and Boston Scientific have been aggressively marketing devices to treat women’s incontinence and pelvic organ prolapse (POP); a condition where the muscles that hold the bladder and reproductive organs in place become weak, allowing the organs to sag or stretch out of shape.  The pelvic mesh is a band of plastic netting that acts like a sling to support the organs.
  • After the mesh is implanted, tissue grows around and through it to form a solid barrier.  Problems can occur if the mesh is strung too tightly, it shrinks, moves, rubs up against muscles or nerves, pokes through the walls of the vagina or rectum, erodes, falls apart, or traps bacteria that cause infections.  This can cause severe pain, bleeding, incontinence, fevers and even death.  The U.S. Food and Drug Administration has reported 77 deaths from the meshes, and at least one Canadian, Chrissy Brajcic, died from infections related to the mesh.
  • The reported rate of complications varies widely, and depends on the source.  While one doctor from the University of California at Los Angeles claims the complication rate is about 1 in 20, a 2017 study of 92,000 records of pelvic mesh surgeries in the U.K. published in Scientific Reports found that nearly 10% of women had complications.  The U.S. Food and Drug Administration issued a report in February of this year that looked at multiple studies and found that “exposure and erosion” of the mesh is “a fairly common (approximately 11-18%) complication” among women who receive the mesh for POP.
  • Women who’ve had problems with the device have had a very hard time getting treatment
    • Many women report being told that their physical pain and symptoms are due to depression or that they are exaggerating their pain.  One woman’s doctor refused to look at samples of threads from the mesh that she collected from her urine.
    • Even when the women are believed, most doctors don’t know what to do about the problem.  A Radio Canada “Enquête” report followed one woman who was advised to try four different treatments by four doctors; she ultimately chose to have the device removed by a fifth doctor (in the United States) who has done more than 1,000 of the procedures.
    • It’s worth noting that the JAMA depression study focused only on women who’d had surgery to deal with problems with the pelvic mesh; it didn’t discuss women who were not believed or treated for the problem.  In other words, the depression rates are probably much higher than those reported in the study.
    • Apparently, once implanted, the mesh is very difficult to remove.  One doctor described it as like trying to get bubble gum out of hair.
  • Most of the products currently on the market were approved through a process common to the U.S. and Canada that allows the sale of new devices that are similar to (“substantially equivalent”) ones already being sold, even if those products are later recalled.
    • One study traced 61 devices back to a pelvic mesh approved in 1996 which was later recalled. “Testing” of such products was done by collecting reports of any problems with the implants. A Toronto surgeon, Dr. David Urbach, pointed out that, once the devices are on the market, it’s “sort of like a large clinical trial, within which we’re all participants.”
    • If it’s a clinical trial, it’s not well run.
      • For instance, doctors and hospitals don’t have to report issues with medical devices.  The materials we looked at  suggested that Health Canada has been unresponsive to doctors and patients who’ve tried to report problems with medical devices.
      • In Canada, only companies that make the devices are required to report problems with their products.
      • So when a woman reports pain or infections, her doctor doesn’t have a data base of mesh-failure reports from other doctors to draw on to help in making the diagnosis.
      • And since the doctor doesn’t have to report the mesh failure, it’s unlikely anyone else will learn about it.
    • As well, information is hard to come by.  Unlike in other countries, information submitted for approval of medical devices, like post-approval studies, inspection reports and warning letters, is not available to the public in Canada.
    • Even where the medical devices are restricted in developed countries (the pelvic mesh has been banned in Australia) companies simply market them in other countries where regulations are less strict.
  • In May of 2014, Health Canada issued advisories about the “potential risk of complications associated with transvaginal implantation of surgical mesh devices…”
    • The advisory for the general public says the mesh devices have “been associated with reports of” a list of symptoms that does not communicate the seriousness of the problems.
    • The advisory suggests that people “review … the patient information that comes with the mesh product, if available,” and “understand the pros and cons” of the procedure.
    • But even the notice to hospitals issued at the same time failed to mention deaths caused by the mesh, referring only to “life-altering events.”
  • Many women have successfully sued the companies that make the pelvic mesh devices, because they were not informed of the risk they were taking when they chose the surgery:
    • They didn’t know how often complications occurred;
    • They were not informed how serious the complications could be (including death);
    • They were not told how difficult it was to treat problems caused by the device;
    • They were not informed that it was difficult or impossible to remove the implant, or that even if the mesh were removed, the damage might be irreversible.
  • The pelvic mesh controversy is similar to scandals linked with other medical devices, and to other women’s health issues.
    • The reporting on the pelvic mesh was part of a global collaboration of journalists looking at medical devices called the Implant Files. The investigation found that many other medical devices have benefited from the same permissive approval schemes, caused injuries and deaths, been dumped in poor countries whose rules are less strict, have been the subject of lawsuits and have prompted calls for increased regulations.  This includes artificial joints, heart valves, Insulin pumps, implanted pain medication delivery systems, and spinal fusion devices.
    • For many women, the pelvic mesh is a grim reminder of the many Intra-Uterine Device contraceptives that have been marketed and recalled over the years, causing injury and death to thousands of women.  It also brings to mind the controversial breast implants that rupture and cause cancer or other illnesses.  Having one’s reproductive system used as a proving ground for experimental devices, then not being believed when those products turn out to be harmful, is yet another example of adding a gender-biased insult to injury.
  • But more important for our purposes: how is it that a person isn’t provided enough information to give informed consent, about a medical device that, once implanted is nearly impossible to remove, and that has a nearly 20% failure rate, which can cause extreme pain, permanent damage, and even death?  And how is it that a person in that position turns to euthanasia as the only way out, and no one bats an eye?

BRITAIN’S ROYAL COLLEGE OF PHYSICIAN GOES NEUTRAL ON AS/E … SORT OF

  • It’s been reported that Britain’s Royal College of Physicians has gone neutral on Assisted suicide.  But as so often happens when the subject is AS/E, you have to look a little deeper to figure out what’s really going on.
  • Bioedge reported that “[b]efore the poll the RCP leadership set the threshold impossibly high” by requiring euthanasia opponents to produce a 60% majority for keeping with the RCP’s current position against AS/E.
  • The vote was taken via an online poll which (not surprisingly) only drew 19% of the RCP’s 36,000 members. The respondents were probably also skewed toward younger members, in that older doctors might be less likely to participate in an online poll.
  • Though 43% of those who voted opposed AS/E, this majority wasn’t large enough to maintain the status quo, even though only 32% supported AS/E.  The remaining 25% of respondents said they felt the College should take a neutral position; this was added to the 32% who supported AS/E, to form a majority.