|
Date
|
Event
|
|
13
September 1999
|
First
application and approval for a PIP silicone gel implant for individual
patient use under the Special Access Scheme (SAS).
|
|
22
September 1998
|
Precise
Medical Supplies lodged application to register three types of breast implant
manufactured by Poly Implant Prothèse (PIP): implants pre-filled with a
polysaccharide solution; implants pre-filled with a silicone gel; and
implants pre-filled with saline.
Applications
to register the polysaccharide-filled and silicone-filled implants were not
pursued due to lack of data from PIP to support registration.
The
application for registration was supported by European Commission (EC)
certification for each implant type issued by TÜV Rheinland in October 1997.
Manufacturer was PIP at 337 Avenue de Bruxelles, La Seyne Cedex, France. EC
certification was based on assessment for Class IIb products.
|
|
15
March 2000
|
PIP
saline prefilled implants, sponsored by Precise Medical Supplies, registered
on ARTG.
|
|
4
October 2002
|
New
medical devices framework introduced in Australia - implantable mammary
prostheses are classified as Class III medical devices.
|
|
16
October 2002
|
Transfer
of sponsorship of all PIP-manufactured products from Precise Medical Products
to Medical Vision Australia.
|
|
31
October 2002
|
First
adverse event report for PIP silicone gel implant (arising from SAS use).
Rupture of implant 2 years post-implantation.
|
|
14
November 2002
|
Medical
Vision Australia applied to include PIP silicone gel implants on the ARTG.
However, the application was not made under the provisions of the new
regulatory framework and was not supported by the correct level of conformity
assessment certification.
|
|
14
April 2003
|
Application
for conformity assessment lodged by Medical Vision Australia for silicone gel
breast implants manufactured by PIP.
|
|
28 May
2003
|
TGA
accepted application for conformity assessment and notifies applicant.
|
|
28 May
2003
|
Evaluation
of application for conformity assessment commences. Application referred
within the TGA for the following evaluations of data provided in the dossier:
a)
microbiological assessment
b)
biocompatibility and biological safety assessment
c)
materials and manufacturing assessment
d)
clinical assessment.
|
|
Date
Event May 2003
|
Arrangements
for onsite audit of the PIP manufacturing facility commenced.
|
|
17-19
November 2003
|
TGA
audit of PIP facilities at 337 Ave de Bruxelles, La Seyne Sur Mer, France.
|
|
15
December 2003
|
Manufacturer
provided additional information relating to non-conformities identified
during the audit.
|
|
March
2004
|
PIP
obtained an EC Conformity Assessment Certificate (covering the necessary
scope for PIP implants) from the European Notified Body, TÜV Rheinland.
|
|
23
August 2004
|
All
non-conformities identified at the TGA onsite audit resolved and the TGA
audit report closed out.
|
|
3
September 2004
|
Application
considered by Medical Devices Evaluation Committee (MDEC) following referral
by the TGA. The MDEC resolution was no objection to the inclusion of these
implants on the ARTG subject to the provision of comprehensive annual
post-market reports to the TGA for a period of 7 years from the date of
inclusion.
|
|
18
October 2004
|
TGA
issued Conformity Assessment Certificates (CAC) to PIP for the manufacture of
a range of silicone gel-filled breast implants. CAC valid for five years.
|
|
3
November 2004
|
Application
by the sponsor Medical Vision Australia for ARTG inclusion of the PIP
implants covered by the TGA Conformity Assessment Certificate.
|
|
30
November 2004
|
PIP
Implants included on ARTG (nine ARTG entries) for the sponsor Medical Vision
Australia.
|
|
4 July
2006
|
First
SAS approval for titanium dioxide coated silicone gel breast implants.
|
|
10
November 2006
|
First
patient enrolled in a clinical trial sponsored by Medical Vision Australia
using PIP titanium dioxide coated silicone gel breast implants.
|
|
4 June
2007
|
TGA
acknowledged clinical trial notification for clinical trial using the PIP
titanium dioxide coated implants.
|
|
31
August 2009
|
TGA
contacted Medical Vision Australia regarding impending expiry of TGA CAC for
PIP implants (expiry on 18 October 2009).
|
|
25
September 2009
|
Medical
Vision Australia submitted an application to vary the manufacturer’s evidence
used to support their ARTG entries for PIP gel-filled implants.
Variation
was requested because the manufacturer was changing from TGA certification
(due to expire on 18/10/2009) to European (CE) certification.
CE
certification was issued by EU Notified Body, TÜV Rheinland, and included
Design Exam certification.
|
|
30
September 2009
|
TGA
accepted the variation to the manufacturer’s evidence with result that PIP
implants were included in the ARTG on the basis of CE certification.
|
|
18
October 2009
|
PIP's
TGA Conformity Assessment Certificate expired after 5 years.
|
|
31
March 2010
|
TGA
notified by Agence Française de Sécurité Sanitaire des Produits de Santé
(AFSSAPS) of its decision to recall and suspend the marketing of silicone
breast implants manufactured by PIP because it had “registered” an increase
in reports regarding implant rupture and local complications and had
discovered that the company had used an unauthorised silicone gel in the
products.
|
|
31
March 2010
|
TGA
contacted by Medical Vision Australia regarding the French recall of PIP
implants.
|
|
1
April 2010
|
TGA
wrote to Medical Vision Australia requesting details of the distribution of
PIP implants in Australia.
|
|
2
April 2010
|
AFSSAPS
advised the TGA that further information would be very difficult to obtain
because PIP officially went into receivership on 30 March 2010 and was
“currently dissolved”.
|
|
3
April 2010
|
Medical
Vision Australia advises TGA that it had ceased importation and supply of PIP
implants, and had contacted medical practitioners requesting that the stock
be returned and not used.
|
|
3
April 2010
|
TGA
request sent to UK Medicines and Healthcare products Regulatory Authority
(MHRA) asking for any further information on the reasons for the PIP recall
in France.
|
|
6
April 2010
|
Request
for information from MHRA for implant rupture rates. Request information from
AFSSAPS for implant rupture rates that led to recall action.
Medical
Vision Australia confirmed that all importation and distribution of PIP
products had been halted. It also advised that it will advise all implanting
surgeons to stop any further operations and return stock to the sponsor.
Note: the 7 customers known to have stock were contacted by email and phone.
All customers acknowledged the email.
|
|
6
April 2010
|
Notice
posted on the TGA website advising that Medical Vision Australia was
undertaking the recall of all non-implanted silicone gel breast implants
manufactured by PIP.
A copy
of the recall notice to customers, the web statement and notification to
colleges is attached
|
|
6
April 2010
|
TGA
sent a copy of the recall notice to the Australasian College of Cosmetic
Surgery (ACCS) and the Australian Society of Plastic Surgeons (ASPS).
|
|
6
April 2010
|
TGA
requested information about implant ruptures from AFSSAPS.
|
|
7
April 2010
|
TGA
requested Medical Vision Australia to send a “Product Notification” to all
surgeons who may have purchased PIP implants.
|
|
7
April 2010
|
Medical
Vision Australia advised all surgeons who have implanted PIP implants sourced
from that company about the recall.
|
|
7
April 2010
|
Response
from MHRA with general outline of the issues as understood. MHRA advice that
rupture rate for PIP implants in UK was “not unusual”.
|
|
8
April 2010
|
State
and territory health departments notified of recall of PIP implants
|
|
8
April 2010
|
“Product
Notification” sent to surgeons by Medical Vision Australia advising that all
unused PIP implants were being recalled due to concerns about their failure
rate and that at this time, no action is required other than the normal
follow-up procedures for patients implanted with this product.
|
|
13
April 2010
|
TGA
follow up with AFSSAPS regarding email request of 6 April 2010, concerning
rate of breast implant rupture.
|
|
14
April 2010
|
PIP
implants cancelled from ARTG.
|
|
29
April 2010
|
AFSSAPS
advised the TGA that, while true rates of rupture were not available, it had
observed a relative increase in the rate of rupture of PIP implants over the
period 2007 to 2009 and it was this apparent increase that led to the
discovery of gel substitution and subsequent recall.
|
|
April
– May – June 2010
|
TGA
performed laboratory testing of samples of PIP implants.
|
|
19 May
2010
|
TGA
website updated with information for consumers stating it was continuing its
investigation into issues relating to overseas reports of increased rupture
rates of PIP implants and that the TGA was awaiting the results of tests
being conducted internationally on the implants.
|
|
10
June 2010
|
TGA
requested AFSSAPS to provide information on the unauthorised gel composition
used by PIP and their test results.
|
|
11
June 2010
|
Outline
of tests to be performed provided by AFSSAPS. No formulation details provided
for unapproved gel other than “the silicone included in PIP implants are
issued from known European industrial suppliers”.
|
|
12
June 2010
|
TGA
requested AFSSAPS to provide production records to match with lots supplied
in Australia.
|
|
22
June 2010
|
AFSSAPS
unable to provide information on production records but advised that they
believed that implants of the types with “MX and Asymmetric references
produced after 2006” would have had the approved gel.
|
|
29
June 2010
|
Email
from AFSSAPS indicating that test results “have been delayed”.
|
|
2 July
2010
|
TGA
website updated with laboratory test results indicating that PIP implants
supplied in Australia conform to the relevant international standards for gel
cytotoxicity and shell strength.
|
|
28
July 2010
|
Email
from AFSSAPS providing information when test results would be available, and
seeking information about the laboratory testing performed by the TGA.
|
|
4
September 2010
|
AFSSAPS
email advising that they had seized implants and raw materials from PIP.
|
|
20
September 2010
|
Request
from MHRA to share the results of the TGA’s laboratory testing.
|
|
28
September 2010
|
AFSSAPS
provided advice about their test results and a copy of the accompanying press
statement.
|
|
8
April 2010
|
State
and territory health departments notified of recall of PIP implants
|
|
8
April 2010
|
“Product
Notification” sent to surgeons by Medical Vision Australia advising that all
unused PIP implants were being recalled due to concerns about their failure
rate and that at this time, no action is required other than the normal
follow-up procedures for patients implanted with this product.
|
|
13
April 2010
|
TGA
follow up with AFSSAPS regarding email request of 6 April 2010, concerning
rate of breast implant rupture.
|
|
14
April 2010
|
PIP
implants cancelled from ARTG.
|
|
29
April 2010
|
AFSSAPS
advised the TGA that, while true rates of rupture were not available, it had
observed a relative increase in the rate of rupture of PIP implants over the
period 2007 to 2009 and it was this apparent increase that led to the
discovery of gel substitution and subsequent recall.
|
|
April
– May – June 2010
|
TGA
performed laboratory testing of samples of PIP implants.
|
|
19 May
2010
|
TGA
website updated with information for consumers stating it was continuing its
investigation into issues relating to overseas reports of increased rupture
rates of PIP implants and that the TGA was awaiting the results of tests
being conducted internationally on the implants.
|
|
10
June 2010
|
TGA
requested AFSSAPS to provide information on the unauthorised gel composition
used by PIP and their test results.
|
|
11
June 2010
|
Outline
of tests to be performed provided by AFSSAPS. No formulation details provided
for unapproved gel other than “the silicone included in PIP implants are
issued from known European industrial suppliers”.
|
|
12
June 2010
|
TGA
requested AFSSAPS to provide production records to match with lots supplied
in Australia.
|
|
22
June 2010
|
AFSSAPS
unable to provide information on production records but advised that they
believed that implants of the types with “MX and Asymmetric references
produced after 2006” would have had the approved gel.
|
|
29
June 2010
|
Email
from AFSSAPS indicating that test results “have been delayed”.
|
|
2 July
2010
|
TGA
website updated with laboratory test results indicating that PIP implants
supplied in Australia conform to the relevant international standards for gel
cytotoxicity and shell strength.
|
|
28
July 2010
|
Email
from AFSSAPS providing information when test results would be available, and
seeking information about the laboratory testing performed by the TGA.
|
|
4
September 2010
|
AFSSAPS
email advising that they had seized implants and raw materials from PIP.
|
|
20
September 2010
|
Request
from MHRA to share the results of the TGA’s laboratory testing.
|
|
28
September 2010
|
AFSSAPS
provided advice about their test results and a copy of the accompanying press
statement.
|
|
29
September 2010
|
TGA
provided advice to MHRA regarding the TGA laboratory test results.
|
|
30
September 2010
|
TGA
requested additional information from AFSSAPS regarding their test results.
|
|
30
September 2010
|
MHRA
requested permission to use information provided by TGA.
|
|
1
October 2010
|
TGA
received advice from MHRA about its web statement.
|
|
1
October 2010
|
TGA
website updated to reference AFSSAPS and MHRA websites for additional
information and confirming TGA test results.
TGA
sent notification of update to TGA’s website to the Australian Society of
Plastic Surgeons and the Australasian College of Cosmetic Surgeons.
|
|
5
October 2010
|
TGA
requested information from MHRA about their awareness of any testing being
undertaken in other countries.
|
|
12
October 2010
|
Medical
Vision Australia advises the TGA that all recalled stock, which had not been
provided to the TGA for testing, had been destroyed.
|
|
12
October 2010
|
Request
from AFSSAPS for information regarding batches of breast implants tested by
TGA.
|
|
22
October 2010
|
TGA
responded to AFSSAPS with requested test information.
|
|
25
October 2010
|
Request
from AFSSAPS for further clarification of TGA’s test results.
|
|
25
November 2010
|
Recall
was closed on TGA database following confirmation from Medical Vision
Australia that all returned product had been destroyed.
|
|
27
January 2011
|
TGA
coordinated simultaneous release of web statement with FDA in the USA
regarding the issue of lymphoma associated with breast implants. TGA
continued to consult the FDA on this issue.
|
|
7
February 2011
|
TGA
held teleconference with Australian Society of Plastic Surgeons to discuss
enhancing the breast implant registry and providing an update regarding PIP
and also regarding ALCL.
|
|
7
December 2011
|
TGA
received information from AFSSAPS about a case of ALCL associated with a PIP
implant and confirming its previous advice to patients. AFSSAPS requested
specific information about breast implants and cases of ALCL in Australia
|
|
21
December 2011
|
TGA
provided advice to AFSSAPS in response to their questions about breast
implants and reported cases of ALCL in Australia.
|
|
21
December 2011
|
AFSSAPS
advised the TGA that in France, media coverage states health authorities were
considering recommending removal of PIP implants from 30,000 women in France.
|
|
21
December 2011
|
TGA
web statement posted regarding media coverage in France linking PIP with
ALCL.
|
|
22
December 2011
|
Updated
web statement from MHRA regarding consultations with other European agencies
and TGA. MHRA stated that there is no evidence of any increase in incidence
of cancer associated with PIP breast implants and no evidence of any
disproportionate rupture rates other than in France.
|
|
23
December 2011
|
Announcement
by the French Minister of Health recommending that women in France have their
PIP implants removed although there is no urgency to do this. Recommendation
was due to the increased rupture rate not to do with any association with
cancer.
|
|
3
January 2012
|
TGA
contacted ASPS, ACCS and RACS and members of TGA’s statutory expert advisory
committees regarding PIP breast implants and establishment of an expert
advisory panel.
|
|
3
January 2012
|
TGA
contacted all state and territory CHOs regarding PIP implants and requested
data from their jurisdictions.
|
|
3
January 2012
|
TGA
contacted regulatory authorities in Switzerland, Canada, Singapore, USA,
Brazil, European Commission and Japan seeking further information on PIP
available in their jurisdictions.
|
|
3
January 2012
|
TGA
contacted Private Health Insurance Administration Council seeking information
on private health insurance data on PIP implants.
|
|
4
January 2012
|
First
meeting of TGA expert advisory panel.
|
|
4
January 2012
|
TGA
website updated with media release and “PIP implants – the Australian
perspective”.
|
|
4
January 2012
|
TGA
contacted NSW Clinical Excellence Commission requesting PIP implant
information.
|
|
4
January 2012
|
TGA
sent letter to all current sponsors of breast implants requesting information
about ruptures, other complaints and number of implants supplied.
|
|
6
January 2012
|
TGA
requested ASPS, ACCS and RACS to instruct their members to assemble lists of
their patients who have received a PIP implant.
|
|
6
January 2012
|
Telephone
discussion with the offices of state and territory CHOs regarding any use of
PIP implants in their jurisdictions.
|
|
6
January 2012
|
TGA
sent further requests for information to regulatory authorities in
Switzerland, USA, Japan, France, Singapore, Canada and EC.
|
|
7
January 2012
|
Breast
Implant Information Line established at 6am.
|
|
7
January 2012
|
Media
release by the Gillard Government announcing new hotline for women concerned
about their breast implants.
|
|
7
January 2012
|
Further
request from TGA To AFSSAPS and MHRA regarding testing requirements/results.
|
|
7
January 2012
|
TGA
web statements on PIP implant Questions and Answers.
|
|
7
January 2012
|
TGA
began contacting surgeons who were supplied with PIP implants.
|
|
7
January 2012
|
TGA
contacted sponsors who may have supplied PIP implants under SAS.
|
|
8
January 2012
|
TGA
discussed with ASPS and ACCS the information being conveyed to their members
by the TGA.
|
|
9
January 2012
|
DoHA
Chief Medical Officer convened a Clinical Advisory Committee to provide him
with regular and frequent advice related to PIP breast implants.
|
|
9
January 2012
|
TGA
requested from European Commission copies of TÜV Rheinland audit reports.
Referred to AFSSAPS.
|
|
9
January 2012
|
TGA
requested information from AFSSAPS on audits of breast implant manufacturers.
|
|
9
January 2012
|
TGA
received response from AFSSAPS to regarding audit reports.
|
|
9
January 2012
|
TGA
received response from AFSSAPS in response to email of 7 January 2012
requesting information regarding testing.
|
|
9
January 2012
|
TGA
contacted Australian Commission on Safety and Quality in Health Care
requesting data on PIP implants.
|
|
9
January 2012
|
TGA
contacted CHOs of each state and territory advising them of the surgeons in
their state who had used PIP implants.
|
|
10
January 2012
|
TGA
sent registered letters to surgeons who may have supplied PIP implants.
Letters also sent to ASPS and ACCS as part of mail out.
|
|
10
January 2012
|
TGA
contacted Chair of Advisory Committee on Safety of Medicines to request
advice on possible study designs that could be used to detect rupture rate of
PIP compared to other prostheses.
|
|
10
January 2012
|
Letter
to ASPS, ACCS and RACS requesting further data on PIP implants for analysis
by TGA and to also request data from the Breast Implant Registry.
|
|
10
January 2012
|
TGA
convened teleconference with state and territory CHOs.
|
|
11
January 2012
|
Communication
with French Government seeking clarification of allegations of fraudulent
activity by manufacturers of PIP implants.
|
|
11
January 2012
|
TGA
convened teleconference of overseas regulators.
|
|
12
January 2012
|
TGA
website updated with information regarding the TGA’s testing of PIP implants,
and an update to Questions and Answers.
|
|
12
January 2012
|
TGA
contacted Medical Vision Australia requesting additional information
regarding supply of PIP implants under SAS.
|
|
12
January 2012
|
TGA
website updated to reflect changes to Questions and Answers on DoHA website
and provide the latest results of laboratory testing.
|
|
12
January 2012
|
Email
to AFSSAPS requesting information about breast implant samples and the
introduction of the gel.
|
|
13
January 2012
|
TGA
requested advice from the MHRA and the European Commission on European wide
plans to ensure the safety of breast implants currently on the market.
|
|
13
January 2012
|
A
summary of TGA’s Laboratory testing results circulated to overseas
regulators.
|
|
13
January 2012
|
Communication
from French Government noting advice from the French Authorities has not been
received regarding allegations of fraudulent activities by manufacturers of
PIP implants, and seeking information on Australian implant rupture rates.
|
|
13
January 2012
|
Email
from AFSSAPS in response email 12 January 2012, regarding tests carried out
on PIP implants.
|
|
13
January 2012
|
Email
to AFSSAPS requesting sample of implant containing each type of gel.
|
|
16
January 2012
|
Teleconference
with state and territory CHOs to discuss available prostheses implant and
removal data that could potentially be used to assess rupture rates.
|
|
17
January 2012
|
TGA
sent letter to ASPS, ACCS and RACS requesting they send further information
to their members in case some PIP implanting surgeons could not be contacted
from the TGA mail-out on 10 January 2012.
|
|
19
January 2012
|
TGA
convened International Laboratory Testing Panel for PIP breast implants to
confer about laboratory testing for the scientific analysis of the quality
and safety of PIP implants: this panel includes Australia, Brazil, the Czech
Republic, European Commission, Germany, Ireland, UK and the Netherlands.
|
|
20
January 2012
|
Second
meeting (teleconference) of TGA’s expert advisory panel on PIP implants.
|
|
20
January 2012
|
TGA
website updated
|
|
20
January 2012
|
Response
from AFSSAPS to email of 13 Jan 2012 re providing samples of gel for testing.
|
|
27
January 2012
|
TGA
website updated.
|
|
30
January 2012
|
Communication
from French Government regarding the use of a different silicone gel and the
outcome of criminal proceedings against PIP founder.
|
|
1
February 2012
|
AFSSAPS
advised TGA of detailed reports (in French) of work undertaken by AFSSAPS.
|
|
3
February 2012
|
Communication
with French Government responding to request for information on the number of
cases of implant rupture rates in Australia, and seeking advice from AFSSAPS
to assist Australian testing program.
|
|
3
February 2012
|
TGA
website updated.
|
|
7
February 2012
|
Intra-dermal
irritation testing on PIP gel and shell commenced.
|
|
9
February 2012
|
TGA
hosted second teleconference of International Laboratory Testing Panel for
PIP breast implants.
|
|
10
February 2012
|
Communication
with European governments (Czech Republic, French, German and Netherlands)
regarding respective policy decisions on PIP implants.
|
|
10
February 2012
|
TGA
website updated.
|
|
17
February 2012
|
TGA
website updated.
|
|
20
February 2012
|
Communication
from Czech Ministry of Health regarding policy decisions on PIP implants.
|
|
23
February 2012
|
Third
teleconference of TGA’s expert advisory panel on PIP implants.
|
|
24
February 2012
|
TGA
website updated.
|
|
1
March 2012
|
Questionnaires
sent to surgeons who have reported ruptures of PIP implants, with the aim of
gathering detailed information about the rupture, the gel, the actual or
potential issues of the rupture and the contra-lateral implant if there is
one.
|
|
2
March 2012
|
TGA
website updated.
|
|
7
March 2012
|
DoHA
received detailed reports of the AFSSAPS chemical, mechanical and biological
testing.
|
|
8
March 2012
|
TGA
hosted 3rd meeting of the International Laboratory Testing Panel for PIP
breast implants (ITPP).
|
|
9
March 2012
|
TGA
website updated.
|
|
10
March 2012
|
Media
release by the Minister for Health, the Hon Tanya Plibersek MP, announcing
access to subsidised MRI scans for women with PIP breast implants from 12
March 2012.
|
|
10
March 2012
|
TGA
website updated with advice on subsidised MRI scans.
|
|
12
March 2012
|
Breast
Implant Information Line script updated with information regarding subsidised
MRI scans for women with PIP breast implants.
|
|
13
March 2012
|
Fourth
teleconference of TGA’s expert advisory panel on PIP implants.
|
|
16
March 2012
|
TGA
website updated.
|
|
23
March 2012
|
TGA
website updated.
|
|
30
March 2012
|
TGA
website updated.
|
|
2
April 2012
|
TGA
website updated.
|
|
5
April 2012
|
TGA
website updated.
|
|
13
April 2012
|
TGA
website updated.
|