Recommendations
Recommendation 1
2.9 The committee recommends that there be
rigorous systems put in place to ensure that medical practitioners provide
consumers with all the information needed to allow them to give fully informed
consent.
Recommendation 2
2.24 The committee recommends that the TGA review
all cases where sponsors have not met their obligations in relation to their
listing on the Australian Register of Therapeutic Goods to ensure that these
cases do not pose any health risk to the Australian public, and that important
data has not been missed.
Recommendation 3
2.25 The committee recommends that the Department
of Health and Ageing include as part of their annual report process,
information on the TGA's procedures for monitoring requirements placed on Class
III medical devices.
Recommendation 4
2.45 The committee recommends that the TGA put in
place measures to ensure that when recommendations made by the Advisory
Committee on Medical Devices (formally the Medical Devices Evaluation
Committee) are not followed, the delegate needs to set out specific and
compelling reasons why the decision was taken.
Recommendation 5
3.21 The committee recommends that the Therapeutic
Goods Administration include in their updates on PIP breast implants, and as
part of any future recalls on other devices or medications, details of the type
of evidence they are pursuing in order to further inform the Australian public.
Recommendation 6
3.27 The committee recommends that the TGA publish
updates and details of the discussions that have taken place with international
regulators.
Recommendation 7
3.44 The committee recommends that the TGA review
its processes to ensure that faulty explanted devices are available to the TGA
for independent testing.
Recommendation 8
3.54 The committee recommends that the TGA's advice
about PIP breast implants include the limitations of the evidence and data to
ensure that consumers and medical professionals alike are in receipt of as much
information as possible that will enable them to make informed decisions about
any future treatment.
Recommendation 9
3.66 The committee recommends that, in light of the
Poly Implant Prothese breast implant recall, the Department of Health and
Ageing establish an opt-out Breast Implant Registry as a priority. The design
of such a registry should be based on the National Joint Replacement Registry.
Recommendation 10
3.75 The committee recommends that the Australian
Government extend the Medicare rebates for MRIs in accordance with the current
medical advice.
Recommendation 11
3.87 The committee recommends that the Department
of Health and Ageing implement recommendations 13, 14 and 15 of the HTA Review
recommendations as soon as possible. The committee notes this recommendation
was also made in its 2011 report on regulation of medical devices
(recommendation 7).
Recommendation 11
4.15 The committee strongly recommends that
professional bodies, particularly the ASPS and ACCS, ensure through formal
advice that surgeons are aware of their responsibilities to ensure that they
provide an ongoing advisory role to their patients even after medical treatment
has concluded.
Recommendation 12
4.29 The committee recommends that the clinical
advisory committee established by the Chief Medical Officer should develop
advice, based on current evidence regarding breastfeeding and PIP breast
implants, as soon as possible, and that this information be included in future
Chief Medical Officer reports on this issue.
Recommendation 13
5.13 The committee recommends that the TGA include
in their advice that it is unclear whether PIP breast implants rupture more
than other silicone breast implants and that further testing and investigation
of PIP breast implants will continue to inform this advice.
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