Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, September 1, 2016

Surgical mesh survey shows 'horrific' patient outcomes.

Wednesday 31 Aug 2016 3:03 p.m.
The severe after effects of surgical mesh implants have been quantified for the first time in a survey, which suggests many problems could go unreported.
Lobby group Mesh Down Under is pushing for change in the way surgeons use the product and is raising awareness for the problems it can cause.
Fifty-seven of the group's 197 members responded to the survey, in which 87 percent said they weren't warned about the potential risks and 91 percent weren't offered an alternative treatment.
The mesh is used in a number of surgeries, including for pelvic organ prolapse and stress urinary incontinence.
The survey's results appear contrary to Medsafe's advice to DHBs and private hospitals last year, which said clinicians should consider research and talk to patients about treatment options, including the risks and benefits "in clear and simple terms".
Mesh Down Under survey results:
  • 70 percent experienced painful sex since surgery
  • 20 percent of cases reported to Medsafe
  • 80 percent needed one or more follow-up surgeries
  • 44 percent had their condition return after surgery
  • Of those who reported complications, 75 percent said GP didn't know about the adverse effects
Group spokesperson and registered nurse Patricia Sullivan said Medsafe had touted the benefits of mesh outweighing the risks.
"The risks are so horrific, that if people knew the risks, really knew how life-changing they are, they wouldn't do it.
"When it goes bad, it goes really bad," she says.
Problems with the mesh can sometimes take years to be felt, with 45 percent of respondents saying they'd had complications between five and nine years after surgery.
Ms Sullivan, who had an implant in 2008, says that makes it difficult for medical professionals to diagnose, with surgeons reluctant to re-operate.
"It took me four years for it to be diagnosed, and in those four years I saw six different specialists."
Ms Sullivan says the implants are faulty products, and pointed to three US states - Kentucky, Washington and California - suing Johnson & Johnson after they allegedly "concealed and misrepresented" the risk of surgical mesh.
Last week, the Government said it would consider creating a registry for the use of surgical mesh along with other recommendations from the health select committee.
The committee recommended:
  • Investigate options for establishing a centralised mesh registry, consistent with international recording of mesh complications;
  • Review best practice around informed consent for surgical mesh patients;
  • Encourage health providers to ensure coding information is consistent so that patients with mesh complications can be identified and monitored;
  • Encourage utilisation of the adverse events reporting system;
  • Endorse ongoing education for surgeons around the use of mesh and mesh removal;
  • Consider expanding Medsafe's role to assess quality and safety of medical devices.
Fellow campaigners Charlotte Korte and Carmel Berry say the recommendations don't go far enough and backed Labour health spokesperson Annette King's call for a full inquiry.
New Zealand First health spokesperson Barbara Stewart says the survey's numbers are concerning and congratulated those who had been "working tirelessly" on the issue.
She urged the Government to adopt all of the committee's recommendations.
"New Zealanders have suffered for long enough. The Government must show leadership," she says.
ACC Minister Nikki Kaye says cost of surgical mesh claims in the 10 years to May 2015 was $7,752,000.
Ms Sullivan says the survey could be considered a pilot study into the effects of surgical mesh because data hasn't been collected by other authorities, including Medsafe.

Wellington, NZ

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