Mr. Tonio Borg
Health Commissioner EC
B-1049 Brussels BELGIUM
October 14 , 2013
Honorability Comissioner Mr. Tonio Borg
My name is Jaume Serra, I´m Plastic Surgeon from Barcelona.
29 days before the French authorities should give the alarm PIP, I had reported the same problem to the Spanish Health Authorities. Also on 01 march 2010, I contacted with europarliamantery Miss Catherine Stihler.
The reason was raise her attention the following situation regarding health complications in relation with silicone implants.
I asked her if she could ask the Commission about rates% of medical complications as rupture, infection, or contracture of silicon implants used in Europe.
She did it 10 march
I recived a email from her, confirming that asked the question.
Question : ” With reference to my question of 21 st july 2009 can the Commission provide me with the percentage of medical complications as ruptures, infections or contracture of silicone implants used in Europe, Can the Commission also provide a breakdown of these complications by Member State?.
Also march 01, 2010, I communicate her that in Spain were occurring irregularities with PIP prostheses.
PIP warning was given March 29, 2010, by French Autorities.
Is a big scandal, but there is irrefutable evidence that the Spanish health authorities knew about problems with PIP prostheses from mid February 2010.
On 01 march 2010, I send official letter addressed to the health authorities informing them about PIP ruptures, asking them to convene a meeting as soon as possible to treat the problem PIP, also requested as soon as possible inform the European Parliament of the PIP problem.
Never received response.
Spanish health authorities were the first in the EU to have data and information on the PIP prostheses, yet not consider it necessary do anything.
September 24, 2013 EC adopted measures to improve the safety of medical implants fulfilling its commitment to restore patient confidence.
If EC wants to improve TRANSPARENCY must know all the irregularities that caused the problem PIP.
How many PIP prostheses broke in the UK, Ireland , Scotland, France or Spain before march 29, 2010?
How many of those breaks were reported to health authorities by the doctors?
Doctors must do their duty and report when things go wrong, but they didn’t.
Why do not surgeons warned of the problems observed?
Why do not surgeons do their duty?
if health professionals did not reported of problems ,¿Can anyone tell me?, How the warning system worked?.
So the lack of data, lack of notification, was unable to detect the very high frequency of PIP, s breaks and act accordingly
Who is responsible for checking the correct operation of the surveillance system?
Surveillance System breast implants was inoperative since its inception.
On October 2006, I alerted Spanish health authorities, that health professionals who were not doing notifications of incidents.
If neither health professionals nor the clinics , notified to the Surveillance Point , complications associated breast implants, Surveillance System did not have data, for this reason the EU could not answer miss Stihtler questions, and most serious was unable to detect the problems PIP.
Main task Surveillance System is the analysis and management of data.
But if there is the fact as proven, that no medical professional, notifying the complications and ruptures, ¿What Data analyzed the Surveillance System? none
It was an open secret since 2008, for plastic surgeons – In Spain – that PIP prostheses broke at an alarming rate.
As medical professionals -the paradigm of scientific method – it is strange to think that none of those who observed ruptures, fell into the account, that this material could be fraudulent, since this was an extremely liquid silicone.
But what also is quite strange is that having observed these breaks, none notified the Health Authorities.
I speak on behalf of women affected by the PIP scandal, as Enilda – spoon photo-, women who are disappointed with the EC.
Many women do not feel heard, and wonder that consisted EU engagement in February 2003 to ensure the safety of breast implants
I speak on behalf of patients who do not feel heard, as it was not Ms. Margot Cameron on 2003, patients who think that you could do more of what you did.
Ten years ago, EC pledged to protect patients, EC pledged to ensure the safety of the implants, unfortunately , words fell on deaf ears.
“Thursday, 13 February 2003 – Strasbourg . DEBATES. A5-0008/2003
Stihler: How did we get to this stage? Over eight years ago a woman called Margot Cameron attended a surgery held by my colleague, Mr Miller. She said that nobody would listen to her. Her story so inspired my colleague that a petition was lodged with the European Parliament
which showed that Margot was not alone. There are many Margots in the UK and across the EU with similar stories concerning problems with silicone.
We must ensure that people make informed choices and we must put patient safety first.
The report recommends Member States to take measures to increase and improve information for patients through tracking and surveillance, quality control and assurance.
This issue will not go away. I hope that in the future more women will be able to make informed choices and they will not have to suffer in the way that so many women like Margot have in the past. I hope that the Commission will be able to report back to Parliament on how far the Member States have gone in implementing this reclassification, and will continue to monitor the issue of silicone-gel breast implants, always putting patient safety first.
Jöns: The constant physical and emotional suffering caused by the implant operations is often immense. As a rule this ought to be avoidable, as the cause is not the implants per se. This has been confirmed in studies, and particularly impressively by the STOA study from the year 2000.
Ries: The truth is that women tempted to undergo this sort of operation which – as has been said – is becoming increasingly common, need to be informed and protected, and that is what we have tried to do.
González Álvarez: I believe that this is an extreme case, and something which obviously does not usually happen, but it is vital that the Member States exercise rigorous control over all clinics and over all products that serve as implants, so improving the situation of those women who, for one reason or another, feel obliged to undergo implant operations.
Van Brempt: Our main aim is to see patients protected. We do not want to patronise them; we want to protect them. That is crucial. We do not want a ban; a woman must be able to decide for herself in good faith whether she wants breast implants or not. What we do want is to ensure that she is properly informed and that she knows what the disadvantages and potential dangers of a breast implant are. We want to guarantee that.
Finally, protecting the patient.”
¿Can the EC, explain to patients what they meant you on 2003, when spoke of protecting them?
None of you verified if the 2003 resolutions were fulfilled?.
If YOUR GOALS are make Europe a healthier, safer place, where consumers can be confident that their interests are protected.
Is If EC want greater transparency, it is necessary to answer these women in the final dossier about PIP scandal.
Many Thanks in advance.
Dr. Jaume Serra