POLY IMPLANTS PROTHESES (PIP): TIME LINE
1991: Poly Implant Prothèse(PIP) founded by Jean-Claude Masa former medical sales representative with “very limited scientific training”.
1994: PIP authorised to produce implants from medical silicone.
March 2000: The US Food and Drug Administration (FDA) refuse to approve a type of PIP implant filled with saline on the basis that research to support the safety of the product was “at best unproven”. Sales in the US were halted.
June 2000: The FDA warn that the implants had been found to be adulterated and that during a visit to the PIP plant 11 deviations from “good manufacturing practises” had been found.
December 2000: The UK Medical Devices Agency (MDA) issue an alert over hydrogel implants manufactured by PIPs. 4,000 women had received the implants but the MDA guidance was that only those with concerns should be offered a consultation. No checks or removal of implants were offered. The product was withdrawn from the market after PIP failed to provide adequate data supporting their safety.
January 2001: By purchasing two different types of gel, silicone oils used in the food industry and industrial silicones, one from America and one from Belgium PIP created a “home made budget” formula which was five times cheaper to make then the authorised version and which they manufactured at their factory in La Seyne-sur-Mer. The new product has been described as being the same grade of material as that used in mattresses.
2006: Plastic Surgeon Ruth Walters becomes concerned with patient suffering as a result of PIP implant and writes case notes for British Journal of Plastic Surgery.
2007: Head of the department of plastic surgery at the University Hospital of North Durham Mr Brook Berry writes letter which is published in The British Journal of Plastic Surgery regarding complications from PIP implants.
2009: UK Solicitors acting for those suffering from as a result of PIP implants contacts the Medicines and Healthcare Products Regulatory Agency (MHRA) who had taken over from the MDA with their concerns. MHRA inform solicitor they had no other reports. French surgeons begin to report abnormally high rupture rates.
31st March 2010 : The MHRA issue a Medical Device Alert (MDA/2010/025) on advising UK clinicians not to implant these devices.
THE PLASTIC SURGEON’S VIEW: In 2007 plastic surgeon Brook Berry head of the department of plastic surgery at the University Hospital of North Durham was operating on a 36 year old breast cancer patient who was receiving treatment on the NHS for a “massive failure” of her silicone implants.
The implants, manufactured by Poly Implants Protheses (PIP) had been fitted three years previously. The PIP implants were cheaper than others and so were used by the NHS and many private hospitals. The implant in her right breast had leaked silicone into the lymph nodes in her armpit. This was the second case like this Mr Berry had seen and the rupture had caused such problems and raised such concerns for Mr Berry that he wrote to the British Journal of Plastic Surgery.
The letter was published in 2007 and in it Mr Berry stated:
“That a high cohesive gel implant could have suffered such a massive failure only three years after implantation is very worrying…the reliability of PIP implants must be questioned and, for myself, I intend to discontinue their use in favour of implants from other manufacturers.”
In an interview with the Telegraph in December 2011 Mr Berry felt that the British Regulator (then the Medical Devices Agency (MDA) now the MHRA) just weren’t interested.
Similar problems had been noted by Ruth Walters, a plastic surgeon at Selly Oak Hospital in Birmingham who in 2006 was operating on a 46 years old woman who had received PIP implants from a private clinic. This was her first encounter with PIP implants and like Mr Berry she was so concerned she wrote a report also published in the Journal of Plastic Surgery. At the time she did not know that Pip implants were systemically faulty. She says that she urged her patient to sue the manufacturer and the clinic for negligence.
Getting away with it:
The Sunday Telegraph reported that the plant would be given 15 days notice of each inspection. This gave the managers time to clear away industrial material leaving only medical silicone in use. The two silicones have been described as radically different; the medical gel didn’t run whereas the fake gel was like “soapy water”. No medical trials were carried out on the fake gel. The silicone suppliers were told the products were being used in hand cream. It is reported that vats of the low grade silicone were removed and stored in another secret PIP warehouse.
THE GOVERNMENT’S VIEW: The UK government who have taken the view that the implants do not warrant routine removal. They state they have been advised that there is no significant increased clinical risk in cases where implants are not replaced.
The Government’s Health Secretary, Andrew Lansley has confirmed the NHS will only fund replacement implant operations for NHS patients fitted with PIP implants.
The Government’s view is that there is a “moral duty” on the private clinics that fitted the PIP breast implants to remove them with the NHS only becoming involved if a private clinic refuses or no longer exists and even then only removing the implant and not replacing it.
The health secretary Andrew Lansley told the House of Commons that it was not fair that the taxpayer should pay and that if the NHS removed an implant then the private clinic responsible would be pursued for their costs.
Mr Lansley, in making his decision, hopes to put pressure on private clinics to follow suit but he cannot force private companies to fund replacement breast implants. It is anticipated reputable companies such as Spire Healthcare will treat their clients for free.
It is believed that 95% of the 40,000 women in the UK who received the implants did so as a result of private treatment.
The Welsh government have now stated that as long as a clinical need can be shown the NHS will also replace those received through private treatment.
The decision was taken as Welsh Health Minister Lesley Griffiths confirmed the view that not replacing breast implants could leave women exposed to unnecessary risk.
Ms Griffiths told the BBC:
“Removing the implants and not replacing them could result in unsightly scarring, loose skin and potentially the accumulation of fluids, need for drainage, and risk of infection.”
It is also felt that it is unnecessary to put PIP victims through the risk of complications arising from having to undergo two separate operations.
The Welsh government have stressed that NHS treatment should however be seen as a last resort. Those affected must be able to show that they have approached their private provider first. They must also be registered with a GP in Wales.
An inquiry team will meet in two weeks time to review the date from private clinics about the failure or rupture rate of PIP implants. Tests are also being conducted on the industrial silicone used in the implants to determine how toxic it was.
A Government campaign designed to reduce the pressure on the NHS is being run.
Aimed to limit the demand for NHS surgery to remove the faulty PIP implants the adverts appeared in national newspapers as well as on social media sites. There is also a poster campaign in GP surgeries and hospitals.
The campaign stresses that there is no clear evidence that the PIP implants will cause any more harm then other brands. It is headed "The NHS will support women with PIP breast implants" and reads:
"The latest advice from the NHS and plastic surgery experts is that women with PIP breast implants do not need to have them removed unless they have symptoms such as pain and tenderness. 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."
"The NHS will remove your implants if your doctor agrees, but the NHS will not replace implants unless it is clinically necessary."
If you are concerned about whether you have received PIP implants or not then women are advised to speak to their GP or specialist and "agree what's best for you."
THE MHRA’s VIEW: The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health. They used to be known as the Medical Devices Agency.
Their role in PIP’s:
According to the MHRA website on 29 March 2010, the French medical device regulatory authority (AFSSAPS) informed the MHRA that it had suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer). They also recalled all of these devices in France. Following an inspection of the PIP manufacturing plant, AFFSAPS established that breast implants manufactured since 2001 had been filled with a silicone gel with a composition different from that approved.
The MHRA issued a Medical Device Alert (MDA/2010/025) on 31 March 2010 advising UK clinicians not to implant these devices.
On 04 October 2010 they issued a further Medical Device Alert (MDA/2010/078) advising UK clinicians on the clinical management of women implanted with PIP silicone gel filled implants. This alert related to all devices implanted after 1stJanuary 2001.
In April 2010, AFSSAPS initiated testing of affected implants to look at the genotoxicity (potential for cancer), chemical toxicity and irritation to biological tissues. In addition, mechanical testing of the implant shell was carried out. At the end of June 2010, AFSSAPS told the MHRA of delays to their product testing. The MHRA state that as they were aware of the concerns of implanting women, it decided to commission some limited testing to obtain an early indication of genotoxicity or chemical toxicity. It was recognised that these were not as extensive as the tests being carried out in France, but it was agreed with the relevant experts on the Committee on the Safety of Devices that these would give very good early information on whether there was a safety problem with the filler material.
In early September 2010 the MHRA announced what they stated were encouraging preliminary results of the UK testing on the silicone gel breast implants manufactured by the French company PIP, with no evidence of safety issues associated with the filler material. On 28 September 2010 AFSSAPS published a statement with the findings of their results(external link). The French results confirmed the UK findings reported at the beginning of September 2010 that there is no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material in the implants. Mechanical testing of the implant shells carried out by AFSSAPS also suggested that there may be an increased risk of rupture.
The Therapeutic Goods Administration (TGA) of the Australian government also carried out tests on PIP breast implants. They concluded that these implants conformed to the relevant international standards for this type of product including those for gel cytotoxicity and shell strength.
There has been some confusion because of the role of PIP in the manufacturing of the Hydrogel product in relation to MHRA alerts. The MHRA alert from 2000 does not relate to the PIP silicone implants which are the cause of some much recent concern.
Hydrogel implants consisted of a silicone elastomer shell containing hydrogel filler. Hydrogels are polymeric materials that have the ability to swell in water without dissolving and retain water within their structures.
Until December 2000, there were two models of hydrogel filled breast implants on the UK market – PIP Hydrogel and NovaGold. Because of continuing concern over the safety of breast implants, the Medical Devices Agency (a forerunner to the MHRA) carried out a series of investigations into the safety of the various filler materials used in the implants available in the UK. The agency's investigations into hydrogel-filled breast implants revealed inadequacies in the manufacturers' biological safety assessments and concluded that there was not enough information to fully assess the safety of either of the hydrogel filler materials. When they were made aware of the results of these reviews, both manufacturers decided to withdraw their hydrogel-filled breast implants from the UK market in December 2000 as a precautionary measure, pending further studies to establish the safety of the filler materials. The Medical Devices Agency issued two alerts at the time: DA 2000(07)- Breast Implants: PIP Hydrogel and DA 2000(08)- Breast Implants: NovaGold.
The MHRA state on their website that it must be emphasised that no definite risk has been identified. The concern lay only with the way the safety of the hydrogel fillers had been assessed. The MHRA is continuing to monitor the safety of these implants and, based on the currently available evidence, does not recommend that women with hydrogel-filled breast implants have them removed unless they are experiencing problems. The MHRA advise that women who think that they may have hydrogel breast implants and are concerned, should contact the surgeon who carried out their operation. Clinicians and members of the public should continue to report adverse incidents to the MHRA.
THE DEPARTMENT OF HEALTH: Below is the guidance currently being given by the NHS to GPs and Surgeons. Patients with any of the symptoms listed below should be referred for a specialist opinion.
Many women who have no physical symptoms are being referred to breast clinics and are then being charged for scans.
GPs should not be refusing to see patients with an initial appointment. Our reading of these guidelines is that this suggestion is only on the basis that clinics will provide similar treatment for free. Patients who have spoken with the clinic or checked their website and who have confirmation that their clinic is not dealing with queries other then on a privately paying basis then you need to make your GP aware of this.
ANNEX E: CLINICAL GUIDANCE FOR GPs AND SURGEONS
Patients: Any patient with breast implants is advised to check the details of their implant with
their surgeon or clinic.
GPs consulted by patients with PIP implants should explore the patient symptoms and examine the breast and locoregional lymph nodes.
Patients with local signs and symptoms should be referred for a specialist opinion.
Signs will include
•Lumpiness of the breast
•Lumpiness/ swelling of the regional lymph nodes
•Change in shape of the breast
•Deflation of the breast
•Tenderness of the breast
•Swelling of the breast
Symptoms may include
Guidance for GPs for NHS specialist referrals
Patients with PIP implants who experience lumpiness within the breast and lymph nodes : In cases where there is concern regarding the nature of the lumpiness, referral should be made to a rapid access breast service. In cases where the practitioner is happy that the lumps are associated with the implant or gel, referral should be made to the regional reconstructive breast surgery department
Patients with changes in shape or feel of the breast, for instance discomfort, deflation or asymmetry should be referred to their regional breast reconstructive unit. These patients do not require fast track referral.
Surgeons: Surgeons and hospital specialists reviewing patients with PIP implants should carefully assess the patient for the possibility of rupture or leak. Those patients who have evidence of implant rupture should be advised regarding the implications of implant removal/ exchange. If it is felt that the risk benefit ratio favours explanation/ exchange then this procedure should be advised. For NHS patients the patient may be offered re-implantation. For patients from the private sector who have been unable to secure help from their original provider, the NHS will offer implant removal where it is felt to be clinically appropriate, but no
re-implantation will be offered.
This guidance may change after consultation with relevant parties.
Guidance for GP referrals for private patients
General Practitioners may be approached by patients who underwent their surgery in the private sector. These patients should be advised to contact their original provider. It is expected by the expert group and the professional bodies represented on it that these providers will offer the same service as the NHS without cost to the patient.
Where a patient decides, after consultation with her GP or specialist, not to have an explanation, she should be followed up on an annual basis. This review would normally be carried out by the GP (for NHS patients) or by the clinic which carried out the original implant (for private patients).
Getting Medical Records
Under the Data Protection Act, requests for access to records should be met within 40 days. However, government guidance for healthcare organizations says they should aim to respond within 21 days. Also some surgeries may try and charge a fee for giving copies. If they do the absolute maximum they can charge is £50. And that includes postage and packaging. Full details of fees can be found at http://www.nhs.uk/chq/Pages/fees-for-accessing-medical-or-health-records.aspx
THE PRIVATE CLINIC’S VIEW: The three main private clinics in the UK who used PIP products are Transform, The Harley Medical Group and Surgicare.
- The clinic has set up a PIP enquiry line 08000 214 102. As of 9thJanuary 2012 it was taking between 7-10 working days to return calls.
- They state they did not use PIP implants before January 2001. They were used between 2001 and 2005. Since 2005 the majority of their implants were supplied by US company Allergan.
- 108 women received PIP implants after 2005. Of these 7 ruptured. The company feels this figure is too small to provide a robust statistical analysis.
- Their view as to why patients were not made aware of potential problems earlier is that it was only in March 2010 that the MHRA announced that PIP implants should no longer be used.
- Their website stresses that to date the UK government has found no evidence to support routine removal of PIP implants.
- Patients’ whose records indicate they received PIP implants are being offered a review appointment with a Transform surgeon free of charge. They state there will be priority access for PIP patients but to expect waiting times of 2 weeks.
- There is no charge for access to medical records but requests must be made I writing to:
Transform Medical Group
- They are not offering any free treatment as “the Government’s stance is there is no requirement for routine removal of PIP implants. They state they are charging a cost price.
- Price of PIP implant removal – £1,850
- Price of removal and replacement with Allergan CUI implant - £2,650
- They are currently refusing to involve insurers as neither the Department of Health or MHRA have deemed the implants faulty.
The Harley Medical Group:
- Mel Braham chairman of the Harley Medical Group feels that as the Medicines and Healthcare products Regulatory Agency (MHRA) approved the implants the moral responsibility should lie with the Government themselves. Mr Braham did however confirm that in his opinion the implants should be removed and replaced if the patient requests it.
- 13,900 HMG patients received PIP implants between September 2001 and March 2010.
- The clinic started collecting rupture date from September 2004.
- Between September 2004 and March 2010 they conducted 11,837 operations with PIP implants.
- Of these 213 ruptures were reported as of 30 November 2011, an aggregate rate of 1.8%.
- 6,010 of these operations are more than four years old and of these 79 ruptures were reported. The clinic believes this is within reasonable statistics.
- PIP patients are asked to call on 0800 022 3387
- Those unable to contact the clinic by phone are asked to complete the PIP contact form
- Alternatively, patients can email PIPpatientIDdata@harleymedical.com
- On 17thJanuary 2012 they posted the following open letter on their website:
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:
- 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.
- 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.
- 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:
- Findout 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.
- Speakto your specialist or GP, if you had them done on the NHS, or your clinic if you had them done privately.
- Agreewhat’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.
The Harley Medical Group
- Their current advice to women with questions about PIP breast implants remains to seek advice from their consulting surgeon.
- Their website displays the following open letter to PIP patients:
We have added a significant amount of resources to enable us to prioritise your request for information around your personal situation and to establish whether you have in fact had PIP implants, we aim to get back to you with information within 7 days of your initial enquiry or submission of your request for that information.
Please note that the make and model of your implants will be on your original discharge document and all patients receive this. We are working through all of our enquiries as quickly as possible and appreciate your co-operation and patience.
SurgicareMedicalGroup’s current advice on PIP implants is the same as that of Prof Bruce Keogh, the NHS medical director who led the expert group review on PIP implants, who concluded that, “we do not think it is necessary to recommend the routine removal of these implants.”
Health Secretary Andrew Lansley also stated that the advice to patients with PIP implants remains the same, and that there is no evidence to suggest routine removal.
The Department of Health’s expert group also concluded “there is no evidence that PIP implants are associated with a higher risk of breast cancer than other silicone gel implants”. “Toxicology tests on samples of filler material in both France and the UK suggested that there was no significant health risk to women who had already received the implants.”
SurgicareMedicalGroupare not recommending routine removal of any PIP implants unless they have ruptured, however we do recognise that many of our patients who have these implants are anxious . We have been auditing our rupture rates for many years in both PIP and other implants that we have now used for several years. We have not found in our data any cause for concern, all our data is routinely reported to the MHRA.
We have collated a number of options for our PIP patients.
Our Clinic's business hours are Monday - Friday 8:00 - 20:00.
We envisage you'll receive a response to your enquiry within 7-10 days.
We are offering free removal on all PIP implants.
We are offering a breast implant replacement procedure with Allergan CUI implants at £2,500. If you want your implants replacing with Allergan Natrelle implants this will cost £2,995.
This option is for patients who no longer want to have implants but want their volume restored, and breasts reshaped after their PIP implants have been removed.
This option is for non Surgicare Ltd. patients who have PIP implants but are unable to have them removed or replaced with their original provider. We can replace their implants with Allergan CUI implants for £3,500 or alternatively Allergan Natrelle will cost £4,000.
Please note that the above 3 options are all available to patients of Surgicare Ltd with Option 4 being available to all patients outside of Surgicare Ltd and Surgicare Medical Group
*These are not limited offers
Symptoms of Rupturing:
Symptoms of ruptures can include pain, heat around the breast area, redness, inflammation or rippling.
THE LAWYERS VIEW: The general opinion expressed by lawyers dealing with these PIP compensation claims is that clinics have a "statutory duty" to do so.
Sam Robson, partner at Slee Blackwell and head of the firms Cosmetic Surgery Claims Team explains:
"Under the Supply of Goods and Services Act clinics have a duty to ensure that the products they supplied were of "satisfactory quality". Quite clearly the PIP implants weren't. The clinics may choose to argue that they weren't aware of this and weren't responsible for the product itself but frankly that's irrelevant. It is the same law for the PIP implants as it is for any product you buy and they just can't get out of it that easily. They are legally bound to put things right and that means either carrying out the replacement surgery or providing funds so it can be carried out elsewhere.
A lot people are asking why are HMG for example, only replacing implants fitted within the last 6 years. The reason is a legal one. If you are going to sue someone for breach of contract you should really do it within 6 years. If you don't then your claim can be "statue barred" which means that the Defendant can get it struck out. So HMG are trying to limit their liability. They are dealing with those who are still within time to bring a claim under breach of contract and I suspect will then look to defend claims over the 6 years on the basis that they are out of time.
Their plan is by no means fool proof as there are many arguments to get round that 6 year time limit to bring a claim but it seems those are the tactics they may be using. For those within the 6 year period even if they do removal and replacement for free there is a claim against the clinic as thanks to them giving your PIPS you've had to undergo an unnecessary surgical procedure. There's also recovery of any other expenses and losses (such as child care, loss of earnings) during your recovery. For those beyond the 6 years don't worry - get the right solicitor and they'll know what to do. There are arguments which are relevant in relation to the date of knowledge and these can and will be raised.
As I say, in terms of compensation when you claim you'll be looking at an award for the fact that you've had to have an unnecessary operation as well as compensation for any complications that may arise from having the PIPs in the first place - so regardless of where you get the OP done of how much you pay etc that's still part of the claim. You are also looking at recovery of any financial losses you've suffered because of having PIPs. Think of this almost as a separate award from the compensation for the implants. Recovery of financial losses means that if you spend money on scans or surgery or lose earnings or have to pay for childcare then that becomes part of the claim as well. The amount of this aspect of the claim depends on the financial impact having PIPs has had on you. The only effect choosing to have free surgery or paying say £4,000 is that this financial part of your claim is worth £4,000 less. Perhaps at some point a private clinic may argue that they won't pay you back the cost of surgery elsewhere because they were offering it for free but there is a view that a patient could not be criticised for choosing to have surgery elsewhere if they’ve lost faith with that clinic.
Many of those bringing a claim are worried about paying for legal fees and are asking exactly what "No Win No Fee" means. On the cosmetic surgery law website Sam Robson has written an article which tries to explains everything. In a nutshell what you are responsible for depends on the agreement you sign with the law firm or claims management company. The general view is that if you're looking into getting legal advice you want to:
1. Contact a solicitor direct not a claims management company.
2. Make sure that you are not going to have to pay anything towards legal fees at any time during your claim.
3. Make sure that you are not going to have to pay anything towards disbursements at any time during your claim.
4. Make sure that the firm will pay for an insurance policy on your behalf.
5. Make sure that if you win nothing will be deducted from your damages.
6. Make sure that if you lose you won’t have to pay anything at all.
Slee Blackwell Solicitors offer a genuine No Win No Fee. This means that if you win you get your compensation and get to keep all of it 100%. We get paid by the defendant. We don't bill the client and we pay for all disbursements including the insurance policy and we recover the costs of these from the defendant as well. If we lose then you won’t get any compensation but we won’t get paid. We won’t bill you for the work that we have done or for the disbursements. The insurance we take out will mean that if you do lose the defendant will get their costs paid and you won’t have to worry about them. We offer this scheme because we feel that our client’s have enough to worry about already without panicking that they’re going to get a massive legal bill on their door mat.
Hopefully We’ve addressed all your concerns and queries about No Win No Fee. If you any questions at all then email me on email@example.com or phone our free phone helpline on 0808 139 1592.