As early as in May 2000 the US Food and Drug Administration performed an inspection of the PIP production site in Southern France. As a result of this inspection the sale of PIP implants was stopped in the US. In a letter to Jean-Claude Mas, the owner of PIP, the FDA stated that the implants were “adulterated” along with eleven other deviations from good manufacturing practices such as lack of sufficient investigation of deflation rate and failure of reporting 120 complaints.
Whether the French Health Authority AFSSAPS was informed by the FDA, about the results of their inspection or not, is unclear.
PIP must have started to exchange the medical grade silicone for industrial silicone probably in 2003. For a while, PIP used both types of gel but probably stopped using medical grade gel around 2005. From that time on, most likely they only used industrial silicone. Roughly estimated: there must have been around 200 000 kilograms of industrial silicone delivered to PIP and nobody considered this suspicious!
Inspections were performed by TÜV Rheinland regularly but they all were announced ten days prior to their visit, which is in accordance with the requirements of the European Medical Device Law.
Starting in 2008, more and more plastic surgeons reported a high failure rate in PIP implants. After an investigation by AFSSAPS, the French Health Authorities banned PIP implants in spring of 2010.
Obviously the PIP implant stock or at least part of it was sold to the Netherlands and the distribution was continued by Rofil Medical under the name “M-implant”. When the Dutch health authorities found out that PIP and M were identical, M-implants were banned in June 2010.
Obviously, it was still possible to continue with the distribution of M-implants. The last report we received was about an M-implant inserted as late as October 2011! The distributing company claims that this M-implant has nothing to do with PIP. Only the name would be the same, but the new product would be produced in Cyprus. The report from our colleagues in Cyprus revealed that there was no production site in Cyprus. Subsequently, the company claimed that the production site was in Korea (North Korea??).
There are also hints that these products were sold to Middle and South America. Hopefully through our well functioning network with the help of our colleagues we can trace them down.
In November of 2011 a patient with PIP implants in France died from Anaplastic Large Cell Lymphoma, which developed in the scar capsular tissue around the implants.
Subsequently, AFSSAPS released a warning that patients with PIP implants should be examined regularly but they did not suggest a prophylactic implant removal. After thorough evaluations the French Society of Plastic Surgery decided to recommend a prophylactic explantation of all PIP implants.
Finally, on December 23rd 2011, AFSSAPS also announced, that all PIP implants should be removed prophylactically. Most of the Health Authorities in Europe were hesitant to follow this recommendation, while plastic surgery societies took the lead and recommended explantation. For example, the German Association of Plastic, Reconstructive and Aesthetic Surgeons convinced the German Cancer Society and the Gynaecological Society to hold a press conference together on January 6, 2012 to announce the recommendation for explantation. BfArM, the German Health Authorities followed and released a recommendation for explantation a few hours later. In many other countries, health authorities are still hesitant to come up with a recommendation for explantation. In a telephone conference of most of the European Health Authorities the majority recommended to wait for more data. They claim that the potential risks of surgery and anaesthesia might be higher than the potential risk of leaving the implants in. There is an error in this logic: considering the high failure rate of these implants, the probability, that these implants rupture within the next few years is extremely high, which means that there is an almost 100% probability that these implants will have to be removed within the life span of the patient, but then under much worse conditions.
What do we know about the health risks of PIP implants?
We can only estimate the number of PIP implant patients to be around 500.000 worldwide. We know that PIP also produced other implants such as Testicle implants, buttock implants and chest implants for men. We know that the industrial gel which was used by PIP has been tested and found not to be toxic. However, there are signs that the gel might have been manipulated after it was delivered to PIP. So, in fact, we do not know for sure whether or not it contains toxic elements. This issue is still under investigation.
We know that the rupture rate of these implants is considerably higher than the normal rupture rate for breast implants which is considered to be 1%.
Most of the Health Authorities declared rupture rates between 5 and 10% for PIP, but the declarations vary. We also know that the inflammatory reaction in PIP implants seems to be unusually high in case of rupture. But even without rupture, patients may develop lymphadenopathy with painful and enlarged lymph nodes as far away as in the groin, mediastinum and neck. Axillary lymph nodes are enlarged in many patients.
Although there were 16 cases of breast carcinoma reported in France in PIP implant patients, there seems to be no relation between PIP and breast cancer. These cases are within the range of statistically expected cases.
Anaplastic Large Cell Lymphoma (ALCL) is a tumor of the immune system. Worldwide 75 patients with breast implants out of an estimated number of more than 10 million patients with breast implants have developed this disease. Four of these patients died.
It seems that the pre-disposition to develop this very rare disease is multi-factorial and not yet completely understood. Chronic inflammation usually plays a role in the development of an ALCL. The risk of developing ALCL for patients with breast implants is, according to the FDA, 1 in 500 000 to 1 million patients. The FDA states: “Patients with breast implants may have a small but increased risk in developing this disease”.
What we still need to find out:
We still don`t know the exact number of patients with PIP implants and M-implants.
The estimation is around 500 000 worldwide.
We still do not know whether more M-implants are still in use, may be even under a third name, either in Europe or South America.
1. There is no further room for discussion. It is mandatory to recommend the explantation of PIP and M-implants.
2. Law suits against plastic surgeons should not be successful according to our legal advisors, since a stockholder must rely on the quality of a product that has been granted a CE mark.
3. It is unnecessary to call for new laws. The existing Medical Device Laws are sufficient. The policies, however, should be changed e.g. inspections without previous announcements.
The European Commission invited me today to join their SCIENTIFIC COMMITTEE ON EMERGING AND NEWLY IDENTIFIED HEALTH RISKS WORKING GROUP ON PIP IMPLANTS.
The first teleconference will be held tomorrow. I am very impressed by the ambitious time table of our chairman Philippe Martin, with a deadline for the scientific opinion to be completed by January 30.
4. This is not a scandal of the breast implant industry. This is a scandal of a group of criminal individuals who don`t mind to harm the health of 500 000 women.
The high quality and safety standards of our breast implant industry deserve to be relied on.
5. We have to negotiate with health insurance companies and convince them to provide the expenses for explantation. We also have to negotiate with our managers to provide replacement of implants at the lowest possible expenses.
6. We all need to cooperate in order to implement patient registries in order to get reliable data and to have a tool for postmarket surveillance.
7. Please bear in mind that our patients have to undergo a period of fear and insecurity. It is essential that we avoid public controversies regarding this issue.
Therefore we appeal to all of you to accept the following organizations as the legitimate representation of all plastic surgeons in the world:
1. On national level: the national society of plastic surgery exclusively. The national societies should also look for partners e.g. medical associations, health care providers, government, cancer societies, other scientific societies and consumer groups, which could be involved. The President of the German Association of Plastic, Reconstructive and Aesthetic Surgeons, Prof. Peter Vogt, was very successful in presenting the statement of the society together with the German Cancer Society and the Gynaecological Society in a press conference.
2. On regional level (such as African, Asian Pacific, European, Ibero-Latin-American, Pan-Arab): the section to which this area belongs should be responsible for statements.
3. For global activities and cooperation with WHO: IPRAS and its quality assurance committee, IQUAM, are the legitimate representatives of plastic surgeons.
IPRAS is committed to serve the national societies and the sections with its network and expertise. We continue to prepare drafts for media releases and send them to you. We shall only approach the media if you ask us to do so.
Thank you all for reporting back to us. All the useful information we received from you helped to clarify the situation and come up with important information which no other institution or organization can provide. Please continue to inform us!
Cordial thanks to all of you who supported our work. We are very grateful for your cooperation and proud of our network excellency!
IPRAS General Secretary
IQUAM General Secretary