What you will sign and what you must be given: consent, quotation and implant card

Almost nobody reads what they sign before surgery, and almost nobody knows what they are entitled to be given afterwards.

This page goes through the four documents surrounding a breast augmentation, with the law in front of us: what the consent form must contain, what the implant card is and why you are entitled to a copy, what the quote must say and what you can ask for from your medical record.

1. The consent form

In writing, and not optional

Act 41/2002, which regulates patient autonomy, puts it this way in its article 8.2:

“Consent shall as a general rule be verbal. However, it shall be given in writing in the following cases: surgical procedures, invasive diagnostic and therapeutic procedures and, in general, the application of procedures involving risks or inconveniences of notable and foreseeable negative impact on the patient’s health.”

And article 8.3 adds two points worth knowing: written consent is required for each of those actions — which is why one is signed for the surgery and another for the anaesthetic — and it shall contain sufficient information about the procedure and its risks.

🚨 And in the Valencian Community, 24 hours in advance

This is what almost nobody knows and what is most worth knowing if you have surgery here. The national act sets no interval between signing and operating. The Valencian rules do, in article 43.9 of Act 10/2014, on Health in the Valencian Community:

“The information preceding consent shall be provided sufficiently in advance and, in any case, at least twenty-four hours before the procedure concerned, provided it is not an urgent activity.”

And the same paragraph closes the door on the practice the deadline exists to prevent:

“Under no circumstances shall information be given to the patient when they are drowsy or with their mental faculties impaired, nor when they are already inside the operating theatre or the room where the medical act or diagnosis is to be carried out.”

🔑 Translated: being handed the consent form to sign on the day, in the preparation room or with a cannula already in, is not “how it is always done”. It is contrary to the rules that apply to you. Here the consent form is signed at least 24 hours before surgery.

What the law requires it to contain

Here is the part almost nobody knows and which lets you check whether a consent form is properly done. Article 10.1 lists the basic information the doctor must provide before seeking your signature:

(a) The relevant or significant consequences the procedure produces with certainty. (b) The risks related to the patient’s personal or professional circumstances. (c) The probable risks under normal conditions, according to experience and the state of science or directly related to the type of procedure. (d) The contraindications.

🔑 Point (b) is the most interesting and the most often breached. The generic list of procedure risks is not enough: the law requires information about the risks that have to do with you — your job, your history, your circumstances. A consent form that could be handed identically to any patient is not meeting that point.

And point (a) has a nuance that also gets overlooked: the consequences the procedure produces with certainty. They are not risks: they are certainties. In a breast augmentation, for example, that there will be a scar.

The principle that describes cosmetic surgery

Article 10.2 says:

“The responsible doctor shall weigh in each case that the more uncertain the result of a procedure, the more necessary the patient’s prior written consent becomes.”

🔑 It is hard to find a legal definition that fits elective surgery with a largely aesthetic result better. A short, generic consent form in cosmetic surgery is precisely the opposite of what that article asks for.

⚠️ The cooling-off period that does not exist

The idea circulates that the law requires an interval between signing and having surgery. It is not true: there is no compulsory minimum interval in Act 41/2002 between consent and the procedure.

What does exist is better, and it is in article 8.5:

“The patient may freely withdraw their consent in writing at any time.”

At any time. There is no deadline, no legal penalty for doing so and no need to justify yourself. If you decide the day before that you do not want to, you do not have to.

⚠️ The financial terms are another matter, a separate contractual one. Here there is one condition and it is in writing in the quote: the deposit is forfeited. Nothing more. It is worth reading when you are given it and not when you need it.

2. The implant card

It is the document fewest people know about and the one that proves most useful over the years.

What the law says

Royal Decree 1591/2009, which regulates medical devices, establishes in its article 33:

“The implants listed below that are distributed in Spain must be accompanied by an implant card: (a) Cardiac implants and vascular implants of the central circulatory system. (b) Central nervous system implants. (c) Spinal implants. (d) Hip prostheses. (e) Knee prostheses. (f) Breast implants. (g) Intraocular lenses.”

🔑 Breast implants are on that list in their own right, at the same level as a hip prosthesis or a cardiac implant.

What it must contain

The same article sets it out:

“The implant card, in triplicate, shall include at least the name and model of the product, the batch or serial number, the name and address of the manufacturer, the name of the healthcare premises where the implantation was carried out and its date, as well as the patient’s identification (national identity document, passport number), and shall be completed by the hospital after implantation.”

And who each copy goes to

“One of the copies shall remain filed in the patient’s medical record, another shall be provided to the patient and the third shall be sent to the supplying company.”

Where a national implant register exists, the supplying company sends a copy of its own to that register. The rules also provide for all of this to be done electronically with the proper safeguards, and for the AEMPS to have access to the data for the purposes of Order SCO/3603/2003, which created the National Implant Registers.

Why it matters to you, a great deal

Because the day you need to know exactly what you have inside you, that card is the answer. It is useful for:

• An imaging check, where knowing the model and the volume guides the interpretation.
• A suspected rupture, to identify the batch.
• A safety notice or a market withdrawal affecting a particular batch.
• A second opinion or replacement surgery, especially if you have it at another practice or in another country.
• Claiming a manufacturer’s guarantee.

⚠️ Keep it the way you keep your ID. If you have lost it, ask: the other copy is in your medical record.

🔑 And if you are about to have surgery: ask about it expressly beforehand. It is an obligation of the premises, it is free and its absence says quite a lot.

When we give it to you here: after the surgery. It is not an administrative delay: the card is taken from the box of the implant that was used, and until the surgery has finished the information to go on it — the model and batch of what you now have — does not exist.

3. The quote

It is not a clinical document, and it is the one that prevents the most upset.

It must be in writing and it must itemise what it includes. In a breast augmentation, the items that have to be clear are: the implants, the theatre, the surgical team’s fees, the anaesthetist, the follow-up appointments, the compression garment and VAT.

At ICPM the quote is fixed and all-inclusive — implants, theatre, anaesthetist, appointments, garment and VAT — and it is given in writing after the first consultation. What it does not include is optional post-operative treatments, which are quoted separately.

And one thing worth asking with the quote in front of you: if a complication arises or a revision is needed, what is covered and what is not. Here the follow-up appointments are included; a reoperation is a separate conversation and is quoted separately.

4. Your medical record

Article 18 of Act 41/2002 recognises the right of access:

“The patient has the right of access […] to the documentation in their medical record and to obtain a copy of the data it contains. Healthcare premises shall put in place a procedure guaranteeing observance of these rights.”

With one limit worth knowing about: professionals may withhold their subjective annotations from the right of access, and access cannot be exercised to the detriment of third parties’ confidentiality.

What is worth having a copy of after a breast augmentation:

• The surgical report, which says what was done, with which implant, in which plane and by which route.
• The implant card.
• The discharge summary and the care instructions.
• The pre-operative photographs. Here they are provided if you ask, on completing the relevant form.
• The signed consent form, of which you should keep a copy.

🔑 The surgical report is the document you will be most grateful for in ten years’ time, and it is the first thing any surgeon you consult later will ask for.

Frequently asked questions

Is it compulsory to sign a written consent form?

Yes. Act 41/2002 establishes that consent is given in writing for a surgical procedure, and that it is required for each of those actions — which is why one is signed for the surgery and another for the anaesthetic.

What must the consent form say?

By law, four things before you sign: the relevant consequences the procedure produces with certainty, the risks related to your personal or professional circumstances, the probable risks under normal conditions and the contraindications.

Do you have to wait a while between signing and having surgery?

In Act 41/2002, the national one, there is no minimum interval. But in the Valencian Community there is: at least 24 hours before the procedure, under article 43.9 of Act 10/2014 — which also expressly prohibits informing the patient once they are already inside the operating theatre. If you have surgery here, that deadline applies to you.

Can I change my mind after signing?

Yes. Article 8.5 recognises free withdrawal, in writing and at any time. The financial terms are a separate contractual matter: here the deposit is forfeited, and that is set out in writing in the quote.

What is the implant card and do they have to give it to me?

It is a document in triplicate that must accompany certain implants, among them breast implants, and which includes the model, the batch or serial number, the manufacturer, the premises, the date and your identification. One copy is filed in your medical record, another is provided to you and the third goes to the supplying company.

I have lost my implant card. What do I do?

Ask for it at the premises where you had surgery: there is a copy filed in your medical record.

Can I ask for my medical record?

Yes. Article 18 of Act 41/2002 recognises the right of access and to obtain a copy of the data it contains, subject to the limit of professionals’ subjective annotations and third parties’ confidentiality.

Which document should I keep without fail?

The surgical report and the implant card. They are the two any professional who treats you later will ask for, and the ones with the most value as the years pass.

Sources

• Act 41/2002 of 14 November, the basic act regulating patient autonomy and rights and obligations regarding clinical information and documentation. Consolidated text, BOE. boe.es. — Article 8.2: consent shall be given in writing for surgical procedures, invasive procedures and procedures with risks of notable and foreseeable negative impact. Article 8.3: written consent is required for each of those actions and shall contain sufficient information about the procedure and its risks. Article 8.5: the patient may freely withdraw their consent in writing at any time. Article 10.1: the basic information required before written consent is sought — the relevant consequences the procedure produces with certainty, the risks related to the patient’s personal or professional circumstances, the probable risks under normal conditions and the contraindications. Article 10.2: the more uncertain the result of a procedure, the more necessary prior written consent becomes. Article 18: the right of access to the medical record and to obtain a copy of the data it contains, subject to withholding professionals’ subjective annotations. ⚠️ The national act establishes no compulsory cooling-off period between signing the consent form and the procedure — but the Valencian regional rules do, in the next source.
• Act 10/2014 of 29 December, of the Generalitat, on Health in the Valencian Community. Consolidated text, BOE. boe.es. — Article 43.9: “The information preceding consent shall be provided sufficiently in advance and, in any case, at least twenty-four hours before the procedure concerned, provided it is not an urgent activity”; and “under no circumstances shall information be given to the patient when they are drowsy or with their mental faculties impaired, nor when they are already inside the operating theatre or the room where the medical act or diagnosis is to be carried out”. ⚠️ This act repeals Act 1/2003, on patients’ rights and information in the Valencian Community, which is the one usually cited out of habit.
• Royal Decree 1591/2009 of 16 October, regulating medical devices. Consolidated text, BOE. boe.es. — Article 33 (Implant card): it lists the implants that must be accompanied by a card, expressly including breast implants; it establishes the triplicate copies and their minimum content — the name and model of the product, the batch or serial number, the name and address of the manufacturer, the healthcare premises and date of implantation and the patient’s identification — their completion by the hospital after implantation, and the destination of each copy: medical record, patient and supplying company; it provides for electronic transmission and for the AEMPS to have access to the data for the purposes of Order SCO/3603/2003, which created the National Implant Registers. The article remains in force under sole repealing provision 1(a) of Royal Decree 192/2023 of 21 March, for as long as the products continue to be placed on the market under article 120, paragraphs 3 and 4, of Regulation (EU) 2017/745.

Book your consultation

Before signing anything, there are two checks you can make yourself: that the consent form mentions risks related to your circumstances, and that you are confirmed in writing that you will receive your copy of the implant card. At our practice in Valencia the quote and the paperwork are given in writing and in good time, not on the day of surgery.

Clinical confirmation by the surgeon