PIP Frequently Asked Questions
Please click here for our frequently asked questions
Last Update:
3 February January 2012 13:50PIP Implant Patient Advice - PIP Implants
Report from the House of Commons Health Committee 28 March 2012
On 28 March 2012, the House of Commons Health Committee reported on the PIP Breast implants and regulation of cosmetic interventions, based on oral evidence by the NHS’s Medical Director Sir Bruce Keogh, the MHRA and two members of the Expert Group appointed by the Department of Health to review the risks associated with PIP implants. In addition, the Health Committee took into account written submissions from a variety of sources, including The Harley Medical Group.
http://www.publications.parliament.uk/pa/cm201012/cmselect/cmhealth/1816/181602.htm
We do not agree with all the points raised in the Health Committee’s report but we welcome its overall direction and subscribe to many of its recommendations. In particular:
• “The Department of Health should propose a framework that would allow women in certain circumstances to combine NHS removal of implants with paid-for private surgery to insert replacements.”
• “Sir Bruce’s review into the regulation of cosmetic surgery interventions should consider how the CE mark system can be strengthened, not only to ensure that changes in products are assessed, but also to ensure that the concerns of national regulators regarding implants manufactured and certified elsewhere are acted upon.”
• “There should be the establishment of an effective national register of implants.”
• “The NHS offer must take into account matters of capacity. The overall number of women affected is significant, and single providers are responsible for a significant proportion of that number. There is no point having a policy stance if it cannot reasonably be carried through. The capacity to undertake the surgery must be assessed and the policy response tailored accordingly. The Committee asks the Department of Health to identify how to make the best use of any space capacity, whether public or private.”
We hope that the Department of Health will act on the key recommendations in the Health Committee report. The Harley Medical Group will continue to gather evidence and work with the Expert Group to help inform their ongoing enquiry.
The Care Quality Commission Clinical Governance compliance review March 2012
The Care Quality Commission Clinical Governance compliance review ordered by the government has been underway since January 2012. The review has found The Harley Medical Group to be fully compliant on all counts reviewed. Please see the link for further information click here
What you should do
If you experience symptoms such as pain, heat around the breast area, redness, inflammation or rippling, please call us on 0800 022 3387 (UK) / 1850 211 547 (Ireland).
If you are unable to contact us on this number, please complete the PIP contact form
As a UK healthcare organisation, all our clinics are registered with the Department of Health’s Care Quality Commission and we adhere strictly to the guidance of the Medicines and Healthcare products Regulatory Agency (MHRA) regarding breast implant information. The MHRA is an agency of the Department of Health and the only competent authority in the UK for medical devices such as breast implants. We have been, and continue to be, in close contact with them regarding the situation surrounding PIP breast implants, which the MHRA approved until they withdrew them from the UK market in March 2010.
Statement from the MHRA: pre 2001 PIP 15th March 2012
The MHRA/Department of Health have issued a statement concerning pre 2001 patients that have Pip implants:
“French authorities had previously advised that only PiP breast implants
that were used after 2001 may have been made with unauthorised silicone
gel. Following an investigation by the UK regulator, the Medicines and
Healthcare products Regulatory Agency (MHRA), the French authorities
have this week reported that PiP implants made before 2001 may also
contain unauthorised silicone gel.
This means an extra 7,000 women, who had PiP implants before 2001, could
be affected. About one in five breast implants need replacing within
ten years, whatever the make, so it is unlikely that all these 7,000
women still have the same PiP implants.”
To read the full MHRA statement please click here
For patients pre 2001:
For the limited number of Harley Medical PIP patients pre 2001, please can you update the data capture fields listed PIP contact form.
We can only confirm which implant you have by securing your medical
records. As a UK healthcare organisation, The Harley Medical Group is
registered with the appropriate regulatory body and therefore adheres
strictly to the Data Protection Act 1998 which prohibits the retention
of personal data for longer than is necessary. In line with the NHS we
only keep cosmetic records for a period of 8 years after the conclusion
of treatment.
In line with the Data Protection Act there is a possibility that your
medical records may have been destroyed. We have been and will continue
to look for your medical records and if they are located we will inform
you of your implant type, although we regret that in many cases it may
be impossible.
Please be assured that The MHRA has stated there is no link to cancer, nor is there any health risk associated with the gel.
We believe that many of you may have already had your implants replaced.
However if you have not please fill in the data capture information: PIP contact form
For any questions and concerns please call our dedicated PIP helpline on: 0800 022 3387 (UK) / 1850 211 547 (Ireland)
We understand and empathise with you and your concerns regarding your
implants and we will continue to help and support you through these
difficult circumstances. The Harley Medical Group understands the need
for all patients to be informed of their specific implant details as
soon as possible, and although this process is taking a long time due to
the high number of patients, we continue to supply this information
wherever possible. To-date we have informed over 12,600 patients
concerning their implant type. We have written to all regarding
information on MRI scan. If you have not received a letter regarding
information on a MRI scan please can you contact our dedicated PIP
helpline on 0800 022 3387 (UK) / 1850 211 547 (Ireland)
The Harley Medical Group
17 February 2012
Dear Patients
We apologise for not having updated you more recently, we have been
focusing on retrieving the remaining archived files and communicating
scanning options to all our concerned patients. To date we have sent out
over 9,400 letters to our patients confirming implant type, if you have
not received this please be assured that our team continue to work hard
in retrieving your information. In addition, we can also confirm that
we have communicated MRI scanning options to all our patients, so if you
have not received this already you should do by the beginning of next
week.
We are continuing to prioritise our rupture patients, they are our
biggest concern at this time, by ensuring they are seen by their surgeon
as quickly as possible. We request that you help us do this by only
booking an appointment with your surgeon when you have a scan confirming
a rupture, your surgeon will need to review your scan information to
help you further.
If you have already filled in the PIP contact form thank you, we have
used this information. If you have not managed to do this yet we ask
that you please submit your details on the PIP contact Form
Once again, please be assured that our teams are working extremely hard
to retrieve files and contact all our patients as quickly as possible.
Thank you
The Harley Medical Group
Statement from The Harley Medical Group 31 January 2012
Dear Patients
We are well underway with organising the archived files for PIP and have
to date sent out over 5,200 letters to our patients. In addition we
have sent out a further 3,000 letters with information detailing how you
can organise to have a MRI scan, with locations, pricing and a referral
letter based on your unique patient identification. This has taken us
some time to organise because we needed to have accessible locations for
all of the UK and Ireland. We do apologise for it taking longer than we
had anticipated but we now have the arrangements in place. If you have
not yet received this information please be assured our teams are
working extremely hard to send this information to you.
We are proposing an MRI scan, however there will be instances as
outlined in our letter to you whereby some women will not be suitable.
In this instance an Ultrasound is the next best alternative.
I am sure that you have all filled in the PIP contact Form or emailed us. But to be double sure if you have not submitted your details please can you do so on the PIP contact Form. This is to ensure that all of our information is 100% accurate.
Once again, if you have not yet received information about PIP or
scanning facilities please be assured our teams are working extremely
hard to send this information to you.
Thank you
The Harley Medical Group
Statement from The Harley Medical Group 25 January 2012
The Department of Health announced on the 24th January two reviews following PIP implant news.
The first review led by Lord Howe, the Minister for Quality, will establish what happened in the UK when the MHRA and the Department of Health learnt about the situation with PIP implants in France. This will be reported by March 2012.
The second review led by Sir Bruce Keogh, the NHS Medical Director will look at whether the Cosmetic Surgery will be regulated. This will take one year and will be reported by March 2013.
The Harley Medical Group is fully supportive of the two reviews. For full details of the two reviews please click here:
Statement from The Harley Medical Group 21 January 2012
Dear Patients
We know that you are waiting for a confirmation letter about your PIP implants. Please accept our apologies if you have not yet received it. Please be assured that we have a dedicated team set up to go through all of the archived records that are still arriving. We are trying to send out as many PIP confirmation letters as possible and have sent 1,900 in the last 4 days. This letter will confirm if you have PIP implants.
In all future PIP confirmation letters we will also confirm the scanning process. Please bear with us and wait for that letter. We are going through the archive records as quickly as we possibly can.
If you are one of the 1,900 patients who have received their PIP letter this week, please bear with us as we will send you the scanning information next week. This was not incorporated into your letter this week because we had not finalised the best options available to our patients.
The scanning information will cover how best to proceed with a scan. It will be very clear with address details and instructions on booking information.
We will continue to update you with any further progress we make. Please rest assured we are all working extremely hard in your best interest.
Yours sincerely,
Statement from The Harley Medical Group 17 January 2012
Dear Patients,
Firstly, thank you to Laura Burgess, Emma Toone and Rachel Oates, who met us on Saturday as representatives of concerned patients and were on the march in London. Thank you also to all our patients who have spoken to our clinics. Your message came across clearly.
We recognise that we should have listened earlier to your individual situations. We would like to say sorry to you all for this and for the experience you are each going through. We really want to help as we know you came to us because we care, and we do care.
We have listened to your worries, the most important one being concern for fellow PIP patients who have discovered that they currently have ruptures and no way to fund their removal and/or replacement.
You also identified that we need to improve communications with all our patients as well as our own staff so that there is continuity with what we are saying overall.
As discussed on Saturday we really want to do our best for our patients. We are working hard to find additional surgeons and hospitals to operate on our PIP patients. We know you will understand our first priority must be in managing patients with confirmed ruptures. We can confirm the following:
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For any patient of The Harley Medical Group with PIP implants who has a confirmed rupture accompanied by a scan within 10 years of implantation, we will remove the implants free of charge.
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For any patient of The Harley Medical Group with PIP implants who has a confirmed rupture accompanied by a scan within 6 years of implantation, we will replace the implants free of charge.
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For any patient of The Harley Medical Group with PIP implants who has a confirmed rupture accompanied by a scan between 6 years and 10 years of implantation, we will replace the implants at cost price. Please note that cost price is dependent on the type of surgery required, which your surgeon will discuss with you during your consultation.
Please note that this aftercare is effective from 17 January 2012 and may be subject to future modifications.
We continue to follow the latest advice available from the NHS, the DoH
and the MHRA. They state that there is no link to cancer and there is no
clear evidence of an increased risk of harm compared to other brands of
breast implants.
They advise that you should:
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Find out if you have PIP implants by checking your medical notes. You can get this information for free from your clinic or through your GP. If you had PIP implants on the NHS, you will receive a letter in the next few weeks.
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Speak to your specialist or GP, if you had them done on the NHS, or your clinic if you had them done privately.
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Agree what’s best for you. Get advice on whether or not you need a scan then discuss appropriate action with your doctor.”
We need to be able to talk to our patients with confirmed ruptures who
have a report from their radiologist as a priority. We fully appreciate
that all of you want to talk to us at once. But we would kindly ask
that you help us give priority to our patients with confirmed ruptures
so that they can get through to us on the telephone.
Please bear with us. We understand your frustrations and worries and we are doing all we can to get back to you as quickly as possible. We will continue to update you with any further relevant information on our website.
Yours sincerely,
The Harley Medical Group
Statement from The Harley Medical Group 13 January 2012
Dear Patients,
We fully understand just how anxious, angry and concerned you are. We are sorry and apologise sincerely.
Our top priority is you.
Although the official government advice from The Chief Medical Officer, Dame Sally Davies remains “there is not enough evidence to recommend routine explantation (removal) of these breast implants” we understand from speaking to many of you would like to have your implants replaced as soon as possible.
Unfortunately The Harley Medical Group does not have enough hospitals, surgeons and staff to manage this alone. Nor does it have scanning facilities.
We will require help. We have spoken today to the NHS again and plan to meet them again next week.
Our first task is to identify those of you with PIP implants. Almost 14,000 of you are involved in this situation. We currently treat around 4,000 patients a year so I hope you will understand the scale of the problem we are seeking to resolve.
We also need your help and patience. Many of you have already helped by filling in the information requested on our website.
We know you want us to come back to you as quickly as possible. However to give you the information you need, we have to match the information you give us with paper files secured in medical archives in different buildings and hospitals around the country. This is a difficult, time consuming task.
Our staff are currently trying to contact those patients who have called or emailed us and have not been spoken to yet. We would like to ask those of you who have already called to bear with us as we increase our capacity to come back to you.
Our best information is available on our website which is constantly updated please visit it regularly.
We recognise our responsibility and are determined to help everyone who has been in our care. In order to do this, we need to be here not only today but also tomorrow. Because of that responsibility, we must be realistic in the promises we make.
We would like to thank you for your understanding and patience in this very difficult time.
We will be meeting some of you tomorrow to listen to your concerns and will communicate to you after that.
Yours sincerely
The Harley Medical Group
Statement from The Harley Medical Group 8 January 2012
The advice from the Department of Health continues to be that there is not sufficient evidence to recommend routine implant removal and women who are concerned should speak to their GP. The Department of Health’s expert review has not established if the rupture rate is higher for PIP implants than for other implants. It has also confirmed that there is no evidence of any cancer risk from the materials used.
PIP implants were licensed in the UK by the MHRA, an agency of the Department of Health, for use in the UK. As a result, the NHS, private clinics, private hospitals and private surgeons used these implants in cosmetic and reconstructive surgery.
Today, some media have quoted inaccurate numbers of operations carried out by our Group involving PIP implants. We have been auditing our rupture records for many years now and have not found, to date, cause for concern. As a large user of PIP implants in the UK, we communicated this data to the MHRA in order to help them put things in the right context. The data we submitted to the MHRA is as follows:
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In total, we conducted 13,900 operations with PIP implants in the UK between September 2001 and March 2010.
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We started collecting rupture data from September 2004.
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Between September 2004 and March 2010, we conducted 11,837 operations with PIP implants in the UK.
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Of these 11,837 operations, we had recorded 213 ruptures at 30 November 2011, resulting in an aggregate rupture rate of 1.8%.
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Of these 11,837 operations 6,010 are four years old or more.
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Of these 6,010 operations, we recorded 79 ruptures four years post implantation, resulting in a rupture rate four years post implantation of 1.3%. This is well within available measurements.
IHAS responds to Government advice on PIP Implants
"IHAS, which represents the majority of healthcare providers affected by
the MHRA failure to detect the faulty PIP implants, welcomed much of
the Secretary of State’s announcement.
Members of IHAS are as much a victim of this fraud as the NHS and the
patients. We all trusted the standards regulator, the MHRA, and the
Department of Health.
The IHAS welcomes the intention for CQC to carry out unannounced
inspections of independent providers. All our members comply with the
CQC guidance framework and are registered by the CQC."
Click here to view full statement
Source: Sally Taber, Director of The Independent Healthcare Advisory Services dated 11 January 2012
IHAS responds to Government advice on PIP Implants
"The IHAS applauds the Department of Health’s decision not to cause women unnecessary worry and trauma by advising immediate explantation of PIP implants. We welcome the clarification of advice today but we now want the Government to face up to their responsibility as regulators of PIP implants. All public and private sector surgeons used these implants, which were not the cheapest on the market, in good faith with the knowledge that they had been approved by the Department of Health agency, the MHRA.
“Our current advice to patients is to visit the website of their clinic provider and follow the advice detailed there. Patients can be assured that all of our member organisations are prioritising patient care above all else and all have all undertaken to provide free consultations for women who would like to consult a surgeon.”
The Department of Health says that their main concern is the safety of and compassion for women who have had PIP implants and are seeking to offer them as much advice and evidence as is available. The government’s expert review has not been able to establish if the rupture rate is higher for PIP implants than for others. It has also confirmed that there is no evidence of cancer risk from the materials used. Therefore their advice remains the same: that there is not sufficient evidence to recommend routine removal and women who are concerned should speak to their GP or surgeon.
“Well before this issue emerged we were encouraging the MHRA development of a national, compulsory, device-based Register, following the dissolution of the breast register in 2006 and we continue to champion this course of action."
Source: Sally Taber, Director of The Independent Healthcare Advisory Services dated 6 January 2012
Statement by Dame Sally Davies
On 23 December 2011, the UK's Chief Medical Officer Dame Sally Davies said: "Women with Poly Implant Prosthese (PIP) implants should not be unduly worries. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned they should speak to their surgeon." Click here to view full statement
Source: Chief Medical Officer Release dated 23 December 2011
Irish Medicines Board Update
The advice of the IMB remains unchanged and it reassures women that there is no current evidence of health risks associated with PIP implants. The IMB continues to advise women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon.
Click here to view full statement
Source: IMB Release dated 23 December 2011
MHRA Statement - 23 December 2011:
“PIP breast implants – UK medical devices regulator says no evidence to support routine removal
Following the announcement in France today, the Medicines and Healthcare
products Regulatory Agency (MHRA) is not recommending routine removal
of PIP silicone gel breast implants in the UK.
We recognise the concern that some women who have these implants may be
feeling but we currently have no evidence of any increase in incidents
of cancer associated with these implants and no evidence of any
disproportionate rupture rates other than in France.
We therefore do not believe that the associated risks of surgery from
breast implant removal can be justified without further evidence.
We will continue liaising with the French medicines and medical devices
regulator and we are awaiting the evidence to support the decision made
in France. This will be evaluated as a matter of priority by our
clinical and toxicological experts and we will issue further advice if
necessary.
In the absence of strong clear evidence to the contrary, we see no
reason to alter our current advice that there is no need to routinely
remove these PIP breast implants.
In the meantime we would recommend that all patients who have questions
about their PIP breast implants should seek advice from their implanting
surgeon.
We had discussions on 21 December 2011 with other health or regulatory
experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary,
Austria, Denmark and Malta. They all agreed that there was no evidence
of any increase in incidents of cancer associated with PIP breast
implants and no evidence of any disproportionate rupture rates other
than in France. Information obtained from the Australian Regulatory
Authority (TGA) is consistent with the figures from all the above
European countries other than France in terms of rupture. They have no
reported cases of lymphoma.
We have continually monitored the safety of these breast implants. In
March 2010 we advised clinicians not to implant these devices and at the
same time advised patients who were concerned about their PIP implants
to consult their implanting surgeon. MHRA commissioned toxicity testing
on the unapproved silicone gel used to
fill PIP breast implants, including genotoxicity and chemical toxicity.
The results of these tests have been discussed with relevant experts and
we have concluded that there is no safety issue related to this filler
material. Similar testing carried out by the French medicines and
medical devices regulator confirmed these conclusions.”
Please click here for more information on the MHRA website
Health or regulatory experts re-affirm no evidence of any increase in incidents of cancer
The MHRA had discussions yesterday (Wednesday) with other health or
regulatory experts from France, the Netherlands, Portugal, Italy,
Ireland, Hungary, Austria, Denmark and Malta. They all agreed that there
was no evidence of any increase in incidents of cancer associated with
PIP breast implants and no evidence of any disproportionate rupture
rates other than in France. Information obtained from the Australian
Regulatory Authority (TGA)
is consistent with with the figures from all the above European
countries other than France in terms of rupture. They have no reported
cases of lymphoma.
We are currently advising that women with any concerns should make an
appointment with their implanting surgeon and have a full discussion.
The MHRA and its experts will be looking carefully at the French safety
statement when it comes out as a matter of priority and issue further
advice as necessary."
Background
Based on reports to the MHRA approximately 1% of women in the UK with
PIP breast implants have suffered implant failure, including rupture.
This contrasts with information from the French medical device
regulatory authority, AFSSAPS, which suggests a failure rate, including
rupture, of around 5% in France.
Source: MHRA Release dated 22 December 2011
Irish Medicines Board Quote
"There is no current evidence of health risks associated with the implants.
The IMB advice
to women with PIP implants continues to be that if they have any
concerns about their breasts or implants they should seek clinical
advice from their implanting surgeon."
Source: IMB Release dated 22 December 2011
MHRA re-affirms non-toxicity of PIP breast implants
“The MHRA is aware of the recent report in France of the death of a woman implanted with Poly Implant Prosthese (PIP) breast implants from Anaplastic Large Cell Lymphoma (ALCL). ALCL is a rare form of cancer which affects cells from the immune system.
The MHRA commissioned testing in 2010 on PIP silicone gel breast implants. Results from this testing confirmed that there was no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material inside these implants. Please note there is no contraindication to pregnancy or breast feeding.
In addition the MHRA is also aware of the US FDA's January 2011 Medical Device Safety Communication entitled "FDA Medical Device Safety Communication: Reports of Anaplastic (ALCL) in Women with Breast Implants". The MHRA informed UK healthcare professionals about the FDA's communication via Medical Device Alert MDA/2011/017, which was issued in February 2011. (http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON108774)
The MHRA has reviewed available evidence for association of cancers for women with breast implants in consultation with the relevant UK professional bodies for breast surgery and surgical oncology and has concluded that there is insufficient evidence to indicate any association with cancer. Additionally the MHRA worked with the Cancer Registry and could find no evidence for any association. The MHRA has not received any reports of women with breast implants of any types in the UK with a diagnosis of ALCL.
The MHRA continues to monitor for any associations of all types of breast implants, including PIP, with cancers and any other health implications. We will continue to liaise with Afssaps and will consider any new evidence which comes to light as a priority. The MHRA's current advice to women with any type of breast implant continues to be that women who have questions about their breasts or think that their implants may have ruptured, should seek clinical advice from their implanting surgeon. There is currently no evidence to support routine removal of PIP or any other type of silicone gel breast implants.
Background
The MHRA was informed in March 2010 by Afssaps that they had suspended
the company’s marketing, distribution and export of PIP silicone gel
breast implants. This was due to an inspection of PIP’s manufacturing
plant which found that most implants manufactured since 2001 had been
filled with an unauthorised silicone gel which differed from the
originally approved material. The MHRA immediately issued advice that
these implants should not be used in the UK and commissioned testing to
evaluate the safety of the implants. UK testing confirmed that there was
no evidence of genotoxicity (potential for cancer) or chemical toxicity
of the filler material inside these implants. “
Source: MHRA Release dated 21 December 2011
Since March 2010 The Harley Medical Group has only been using Allergan implants.
Media Queries
Media queries for UK only:
Hannah Walsh
Rain Communications
Tel: 020 7828 0118
Mobile 07966 468 307
Media queries for ROI only:
Sharon Plunkett
Plunkett Public Relations
62b York Road
Dun Laoghaire
Co Dublin
Tel: 012807873
Mobile 087 8260833
Flexible Finance Available
To help make treatments even more affordable. The Harley Medical Group offers a range of flexible finance options for you to choose from to help spread your cosmetic surgery cost.
