In short
- PIP: the AEMPS recommends removing them even when there are no symptoms, and adds that removal is not a matter of urgency and is planned between patient and surgeon.
- 🔑 The reason is rupture, not a risk of disease. The agency itself confirms that there is no greater health risk than with other implants; what there is is a probability of rupture that can exceed 40% at ten years according to the Spanish data.
- Allergan (Biocell and Microcell): preventive explantation is NOT recommended. They left the market because the French notified body did not renew the CE certificate, not because of a safety alert about the ones already implanted.
- If you do not have your PIP implants removed, the follow-up recommended is clinical and radiological every six months, with ultrasound and MRI if the result is inconclusive.
- ⚠️ And if you do not know which implants you have, which is the commonest situation after fifteen years, it can be found out: there is a clinical record, an implant card and a national register.
- Going many years without a check-up is not an emergency, but it is a good reason for a consultation with an ultrasound scan.
Two implant brands left the Spanish market and the official recommendations for the women who carry them are opposite ones. With PIP implants, the AEMPS recommends removing them even when there are no symptoms at all. With Allergan’s textured implants, the same agency does not recommend preventive explantation: it asks women to keep up their check-ups and to seek advice if any problem appears.
It is not a contradiction. They are two different cases: one is a manufacturing fraud with an abnormally high rupture rate, and the other is the expiry of a certificate. Knowing which of the two is yours completely changes what should be done.
This page is the way in to the removal and replacement of breast implants.
PIP implants
What happened
Poly Implant Prothèse was a French manufacturer that filled its breast implants with a silicone gel different from the one declared. The implants were withdrawn from the market in 2010 and the AEMPS published its first safety notice on 31 March 2010.
What the AEMPS recommends
In its notice of 30 October 2013 (reference PS, 18/2013), the agency updates its recommendations and says two things that are worth reading together:
“The absence of greater health risks for women carrying PIP implants compared with women carrying other breast implants is confirmed.”
And at the same time:
It recommends “the removal of PIP breast implants even in the absence of clinical symptoms”, specifying that “the removal of the implants will be planned appropriately by the surgeon and the patient, as it is not a matter of urgency”.
🔑 The two sentences together are the full message, and separately they mislead. It is not that these implants cause illness: it is that they rupture far more often. According to the Spanish data analysed, the probability of rupture can rise to more than 40% by ten years; the European scientific committee SCENIHR estimated up to 30% at ten years, against 2-15% for other breast implants.
What is done if you do not have them removed
The official recommendation for anyone deciding not to be explanted is clinical and radiological follow-up every six months, with ultrasound monitoring and, if the information is inconclusive, magnetic resonance imaging. If rupture is detected or suspected, explantation is indicated.
Allergan’s textured implants
What happened
On 19 December 2018 (reference PS, 26/2018), the AEMPS announced the end of the marketing and use of the textured-surface breast implants and tissue expanders Microcell and Biocell manufactured by Allergan.
The reason was regulatory: the French notified body GMED did not renew the CE marking certificates because it had requested additional information from the company. With no certificate in force, the products could not be marketed in the European Union.
What the AEMPS recommends to the women who carry them
Here is the difference from PIP, and it is explicit:
“Patients should keep up their regular check-ups and, should they experience health problems that they believe may be due to their implant, they should see their doctor.”
⚠️ There is no recommendation for preventive explantation. No regulatory authority, in Spain or outside it, recommends removing textured implants from women without symptoms.
🚨 And a warning about how this information gets used. Fear of implant-associated lymphoma and of withdrawn brands is sometimes used as a sales argument to win explant cases. It is advertising by fear, it is punishable and it goes against the code of professional conduct. This page does not do it and it is as well to be wary of anyone who does. What is known about BIA-ALCL lymphoma, with the official figures, is on its own page.
If you had surgery fifteen or twenty years ago
This is the commonest case and it does not always involve a withdrawn brand. It usually involves something else: that nobody has looked at that implant since.
What changes with time:
- The probability of rupture increases over the years. A silicone gel implant can rupture without giving any symptom at all —silent rupture— and it can only be seen on imaging.
- The capsule thickens and can calcify, which can be felt and changes the shape.
- The breast has changed on its own account. Weight, pregnancies, the menopause: the implant that fitted then may not fit now.
What does not change: there is no expiry date and no obligation to change the implant at ten years. It is set out in full on the page about how long implants really last.
What a check-up involves
It is not surgery and it is not a commitment. It is a consultation with three parts:
- Finding out what you have. Brand, model, volume, plane and date. If you do not know, there are ways of reconstructing it.
- Examining. Shape, symmetry, firmness, the position of the fold, whether the breast has changed and since when.
- Looking. Ultrasound as a first approach and magnetic resonance imaging if there are doubts or if what is being looked for is a silent rupture. The FDA considers MRI the most effective method for detecting it and ultrasound an acceptable alternative for screening in patients without symptoms.
Three possible conclusions come out of that: that everything is fine and there is nothing to do; that the check-up should be repeated at some interval; or that there is a finding that makes surgery advisable. All three are valid outcomes of a check-up.
And if you do not know which implants you have
It is the usual situation when fifteen years have gone by, and more so if the clinic where you had surgery has closed. It can be reconstructed, and there are several ways: the implant card that must be given to the patient, the clinic’s medical record, the surgical discharge report and the national register of breast implants. It is set out in full on the page about the implant card and the SREIM register.
🔑 And if it does not turn up by any route, that is not a dead end either: the imaging says whether the implant is intact and in which plane it sits, which is what decides what to do. What cannot be known without the documentary record is the brand.
How often check-ups are done here
🔑 An annual check-up with ultrasound. It is the follow-up test of choice for availability, for cost and because it involves no radiation, and it detects the changes that matter well.
And if something appears that raises a suspicion of rupture, it is confirmed with magnetic resonance imaging. That is the order: ultrasound keeps watch, MRI confirms.
⚠️ It is not the same as the agencies’ recommendations, which are addressed to whole populations and not to one particular patient: the FDA’s for gel implants starts at 5-6 years and is repeated every 2-3, and the AEMPS’s for PIP was at 6 months. This practice’s rule is tighter and simpler to remember.
Book an appointment
You can book your own appointment. Pick the day and time from the free slots in the diary, in a panel that opens right here, without leaving this page.
Frequently asked questions
I have PIP implants — are they dangerous? Should I change them now?
The AEMPS recommends removing them even if you have no symptoms, and at the same time confirms that they do not carry a greater health risk than other implants. The reason for the recommendation is the rupture rate, which in the Spanish data can exceed 40% at ten years. The agency itself says that removal is not a matter of urgency and that it is planned between the patient and the surgeon.
I have Allergan textured implants — do I have to have them taken out?
There is no official recommendation for preventive explantation. The AEMPS asks women to keep up their regular check-ups and to see their doctor if any problem appears that they believe is related to the implant. The withdrawal from the market in December 2018 was because the CE certificate was not renewed, not because of an alert about the implants already in place.
I had surgery 15 years ago and have never changed the implants — do I have to do anything?
You are not obliged to change them because time has passed. It does make sense to have them checked, because the probability of rupture increases over the years and a gel rupture may give no symptom at all. A consultation with an ultrasound scan settles the question.
What does an implant check-up involve and how often is it done?
Consultation, examination and ultrasound, with MRI if there are doubts. On how often, there is no single consensus: the FDA recommends imaging to detect silent rupture, and in the particular case of PIP the AEMPS specifies clinical and radiological follow-up every six months for anyone who is not explanted.
If a PIP implant of mine ruptured, am I entitled to anything?
That is a legal question and not a medical one, and it depends on your case, on the clinic where you had surgery and on the time limits. This page cannot advise you on that; what it can tell you is that keeping the implant documentation is what makes any claim possible, and that is why it is worth asking for it and keeping it.
Is it true that old implants cause more cancer?
No. No health authority says so, and the AEMPS expressly rules out a greater health risk with PIP compared with other implants. Implant-associated lymphoma exists, it is very rare and it has its own official figures, which are on its page.
Can I use the check-up to think about having them taken out?
Yes, and it is a frequent conversation at that consultation. Having a check-up commits you to nothing: of the three possible outcomes, two do not involve surgery.
Sources
- Update of the information and recommendations on Poly Implant Prothèse (PIP) breast implants. Information notice PS, 18/2013 of the Spanish Agency of Medicines and Medical Devices, 30 October 2013. aemps.gob.es — It recommends removal “even in the absence of clinical symptoms”, not as a matter of urgency; it confirms the absence of greater health risks compared with other implants; it puts the probability of rupture at more than 40% at ten years according to the Spanish data and records SCENIHR’s estimate of up to 30% against 2-15% for the rest; and it establishes clinical and radiological follow-up every six months for anyone who is not explanted, with ultrasound and MRI if it is inconclusive. Checked on 05-09-2026.
- End of the marketing and use of certain breast implants from the company Allergan. Information notice PS, 26/2018 of the Spanish Agency of Medicines and Medical Devices, 19 December 2018. aemps.gob.es — End of the marketing of the textured implants and expanders Microcell and Biocell because the French notified body GMED did not renew the CE marking certificates. For the women who carry them: “they should keep up their regular check-ups and, should they experience health problems that they believe may be due to their implant, they should see their doctor”. There is no recommendation for preventive explantation. Checked on 05-09-2026.
- Risks and Complications of Breast Implants. U.S. Food and Drug Administration, updated 14 December 2023. fda.gov — Magnetic resonance imaging is the most effective method for detecting silent rupture of silicone gel implants and ultrasound is an acceptable alternative for screening in asymptomatic patients. Checked on 05-09-2026.
- Follow-up of the protocol for the detection in Spain of anaplastic large cell lymphoma (ALCL) associated with breast implants. Sixth report. Spanish Agency of Medicines and Medical Devices, 3 June 2026. aemps.gob.es — 146 suspected notifications and 111 confirmed cases up to 2025. Checked on 05-09-2026.
Book your consultation
If you have gone years without a check-up or you do not know which implants you have, a consultation with an ultrasound scan settles most of the uncertainty. Three possible answers come out of it, and two of them do not involve an operating theatre.
Clinical confirmation by the surgeon
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