The real risks of breast augmentation: complications and how often they occur

The breast augmentation guide already publishes the FDA figures, which is more than almost anyone does. This page goes a step further: what each complication is, when it appears, what makes it more likely and what is done about it.

And it starts with the figure that most resets the conversation: the FDA publishes a list of twenty-six local complications of breast implants, and the criterion for being on that list is occurring in at least 1% of patients.

First of all: the FDA list

It is the best starting point because no clinic publishes it.

The FDA maintains a table of local complications and adverse outcomes that occur in at least 1% of breast implant patients, at any time. There are twenty-six:

asymmetry · breast pain · breast tissue atrophy · calcification · capsular contracture · chest wall deformity · deflation · delayed wound healing · extrusion · haematoma · iatrogenic injury · infection, including toxic shock · inflammation and irritation · lymphoedema or lymphadenopathy · malposition or displacement · necrosis · changes in nipple or breast sensation · implant palpability · ptosis · redness or superficial bruising · rupture · seroma · skin rash · unsatisfactory shape or size · implant visibility · rippling or wrinkling of the implant.

🔑 None of this is a statistical rarity. The criterion for appearing there is exceeding 1%. And the FDA adds a sentence worth reading in full: you may need non-surgical treatments or additional surgeries to treat any of these.

That does not make breast augmentation a dangerous operation. It is one of the most widely performed procedures in the world and its rate of serious complications is low. What it does is put the conversation where it belongs: it is not a procedure without consequences, and the decision is taken knowing that.

What the follow-up studies say

Manufacturers are obliged to follow their patients for years and publish the results. In patients having primary augmentation with a silicone gel implant:

⚠️ Read carefully what that 36% counts. It covers everything from further surgery for a change of size to a genuine complication. It does not mean that one in three women has a medical problem; it means that one in three had needed more surgery or had recorded some complication by seven years.

And the figures vary with the implant, the technique and the patient. They come from large multicentre manufacturer series, not from any one practice.

Capsular contracture, in detail

It is the complication that defines this operation and it deserves explaining properly.

What it is. The body forms a capsule of tissue around any foreign body. That is normal, expected and happens every time. It is called capsular contracture when that capsule thickens and contracts, squeezing the implant: the breast feels harder, higher, rounder and sometimes uncomfortable.

The four Baker grades, as the FDA describes them:

Grades III and IV are considered severe and may require further surgery. That surgery usually involves removing the implant, with or without replacement. ⚠️ And it can happen again after the surgery that corrects it.

What changes the risk of contracture

Here there is comparative evidence, from a meta-analysis of 24 studies:

• Surface: smooth implants had significantly higher rates than textured ones — OR 2.80 (95% CI: 1.92–4.08). Another meta-analysis, of 13 papers and 5,440 patients, points the same way: OR 0.26 in favour of textured.
• Plane: subpectoral had significantly lower rates than prepectoral — OR 0.35 (0.25–0.50).
• Filling: no significant difference between silicone and saline.

⚠️ The authors themselves warn of the limitation: there are no large randomised trials on this, so these are associations, not proof of causation.

And the two FDA sentences worth knowing

1. “The cause of capsular contracture is not known.” It is known to be more frequent after infection, haematoma and seroma — but not why it happens to one patient and not another.
2. “The FDA has not cleared or approved any device to treat or reduce the incidence of capsular contracture.”

🔑 That second sentence is the one that most protects a patient. Any product, implant or technique sold as “preventing capsular contracture” is making a claim no regulator has accepted.

🔑 The trade-off nobody explains: texture and lymphoma

Here are two things always reported separately, set side by side:

• Textured surfaces give less capsular contracture. That is what the two meta-analyses cited above show.
• The risk of BIA-ALCL lymphoma is higher with textured than with smooth implants. That is the FDA’s express position.

So there is no surface that wins on everything. You choose by accepting a profile, not by avoiding the risk — just as with the plane, where subpectoral trades less contracture and less haematoma for more displacement and more animation deformity.

What BIA-ALCL actually is, how often it occurs in Spain and what it means for anyone who already has implants is in the page on BIA-ALCL lymphoma and breast implant illness.

🔑 And the house standard follows from that: the surface and the plane are adapted, personalised and agreed with each patient. There is no “house” surface and no default plane applied to everyone.

Put another way: if no option wins on everything, choosing by protocol would be choosing badly. What we do is put both risk profiles on the table — with your anatomy, your history and what you prioritise — and decide it with you. That conversation is part of the surgery, not a formality beforehand.

Implant rupture

First of all: it is almost always silent. The FDA says so clearly: most silicone implant ruptures give no symptoms, do not change how the implant looks or feels, and the surgeon may not detect them by physical examination.

When it does give signs, there may be a decrease in the size of the breast, a change in shape, hard lumps over the implant or on the chest, an uneven appearance between the two breasts, pain or tenderness, tingling, swelling, numbness, burning or changes in sensation.

How it is detected. MRI is the most effective method for detecting a silent rupture of a silicone gel implant. Since December 2023 the FDA has also accepted ultrasound as a valid screening alternative in patients without symptoms.

What types there are. When the gel escapes but remains contained within the tissue capsule, it is called an intracapsular rupture. If the gel passes through that capsule, extracapsular. And if it migrates to distant parts of the body, extracapsular rupture with gel migration — and the FDA warns that silicone can be difficult to remove after a rupture.

What causes it. Among other things: capsular contracture, compression during a mammogram, damage from surgical instruments, procedures on the breast such as biopsies, normal ageing of the implant, trauma, excessive handling during surgery and placement through an unapproved route.

⚠️ And one technique expressly advised against: closed capsulotomy — squeezing the breast by hand to break the capsule — which is a known cause of rupture.

The house protocol, so that nobody has to look for it: check-ups at one week, 2 weeks, one month and at 3, 6 and 12 months — and an annual ultrasound thereafter. ⚠️ These are indicative dates: they depend on each case and may vary slightly, because the calendar adapts to progress and not the other way round.

🔑 That annual imaging follow-up is the practical answer to the paragraph above: if most ruptures are silent and cannot be detected by examination, the only way to see them is to look. When a replacement is considered and what happens next is in the page on how often implants are replaced.

The complications of the first few days

These appear early and are what post-operative care watches for:

• Haematoma. A collection of blood near the surgical site. It can cause swelling, bruising and pain. Small ones are reabsorbed; large ones need surgical drainage. They usually occur shortly after surgery, but can appear at any time when there is trauma to the breast.
• Infection. Most appear between a few days and a week afterwards, although it is possible at any time. ⚠️ If it does not respond to antibiotics, the implant may need to be removed.
• Seroma. A collection of fluid around the implant. Small ones are reabsorbed; large ones need draining.

All of them have their own warning sign, and telling them apart from normal is the subject of the page on warning signs.

The ones that appear over the years

• Malposition or displacement. The implant moves out of place, through gravity, trauma or contracture. It is more frequent in the subpectoral plane than the prepectoral.
• Rippling. Wrinkles in the implant that are visible or palpable through the skin. More likely the less of your own tissue covers the implant.
• Palpability and visibility. The same mechanism.
• Animation deformity. The implant deforms when the pectoral contracts, in the subpectoral plane. It is explained in the page on living with implants.
• Breast tissue atrophy. Thinning of the tissue covering the implant over time.
• Calcifications. Hard lumps under the skin around the implant. ⚠️ The FDA warns that they can be mistaken for cancer on a mammogram and lead to additional surgery.
• Changes in nipple sensation, which have their own page: what is normal and what is not.

What the FDA has ruled out and what remains open

Ruled out: “The FDA has not detected any association between silicone gel implants and connective tissue disease, breast cancer or reproductive problems.” It is a verbatim sentence and it matters.

Open: the systemic symptoms some patients describe as “breast implant illness”, and the reports of squamous cell carcinoma, lymphomas other than BIA-ALCL and mesenchymal tumours, including sarcoma, in the capsule surrounding the implant. The FDA is still gathering data. All of that is set out in its own page.

What you decide also changes the risk

Not everything depends on biology. These decisions move the figures:

• The surface of the implant — contracture against BIA-ALCL.
• The plane — contracture and haematoma against displacement and animation.
• The size. A large implant over little of your own tissue increases palpability, rippling, visibility and tissue atrophy. It is set out in the guide to choosing the size.
• The route of access, explained in the page on where the scar goes.
• Combining procedures, which lengthens the operation.
• Smoking, which the FDA names expressly among the causes of necrosis.

Frequently asked questions

What is the most frequent complication of breast augmentation?

Capsular contracture, which is also the most characteristic of this operation. In the FDA follow-up studies it appears in around 7% at grade III–IV — the grade that may require surgery — and 9% at grade II.

Is it true that 36% have complications?

That 36% is the proportion of primary augmentation patients with silicone gel who by seven years had had some complication or some further surgery, in the follow-up studies the FDA requires of manufacturers. It covers everything from a change of size to a genuine complication, so it does not equate to “one in three has a medical problem”.

Which implant gives least capsular contracture?

Textured surfaces: in a meta-analysis of 24 studies, smooth implants had almost three times as much contracture (OR 2.80). But the risk of BIA-ALCL lymphoma is higher with textured ones, so there is no option that wins on everything. The filling — silicone or saline — showed no significant difference.

How do I know if an implant has ruptured?

Often you will not: most silicone ruptures are silent and are not detected on physical examination. That is why imaging check-ups are done. MRI is the most effective method, and since 2023 the FDA has accepted ultrasound as a valid alternative in patients without symptoms. Here the follow-up is an annual ultrasound, after the first year’s schedule of check-ups.

Can a mammogram rupture my implant?

Compression during a mammogram is among the causes of rupture the FDA lists. Even so, mammograms must carry on: what you have to do is say that you have implants when you book the appointment, so that the specific views are used.

Is there any implant or treatment that prevents contracture?

The FDA has not cleared or approved any device to treat or reduce its incidence, and it also states that its cause is not known. Any product advertised with that promise is running ahead of what any regulator has accepted.

Do implants cause autoimmune disease or breast cancer?

The FDA states expressly that it has not detected any association between silicone gel implants and connective tissue disease, breast cancer or reproductive problems. What is under investigation are the systemic symptoms and some tumours described in the capsule, which are explained on their own page.

Sources

• Risks and Complications of Breast Implants. U.S. Food and Drug Administration, updated 14 December 2023. fda.gov. — The list of local complications occurring in at least 1% of patients; implants are not lifetime devices and the longer they are worn the greater the likelihood of complications; the Baker grades and the classification of grades III–IV as severe; the absence of any cleared or approved device to treat or reduce capsular contracture and its unknown cause; the silent nature of most silicone ruptures, MRI as the most effective method and ultrasound as an acceptable alternative in asymptomatic patients; intracapsular and extracapsular rupture and rupture with gel migration; causes of rupture, including compression during a mammogram and closed capsulotomy; no detected association with connective tissue disease, breast cancer or reproductive problems; reports of squamous cell carcinoma, other lymphomas and mesenchymal tumours in the capsule.
• Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). U.S. Food and Drug Administration. fda.gov. — The risk of BIA-ALCL is higher with textured-surface implants than with smooth-surface ones; the type of filling does not appear to be a risk factor.
• Haas E, et al. Capsular Contracture After Breast Augmentation: A Systematic Review and Meta-Analysis. Aesthetic Surgery Journal Open Forum, 2025. PMID 39989707. — 24 studies: smooth implants associated with significantly higher rates of capsular contracture than textured ones (OR 2.80; 95% CI: 1.92–4.08); subpectoral placement with significantly reduced rates against prepectoral (OR 0.35; 0.25–0.50); no significant difference between silicone and saline (OR 0.39; 0.02–6.69); the authors note the absence of large randomised trials.
• Zhai P, et al. A systematic review and meta-analysis of capsular contracture rate after breast augmentation with textured and smooth breast prostheses. Gland Surgery, 2022. PMID 35242678. — 13 papers and 5,440 patients: a significantly lower incidence of capsular contracture with textured than with smooth implants (OR 0.26; 95% CI: 0.08–0.81).
• Li S, et al. Complications Following Subpectoral Versus Prepectoral Breast Augmentation: A Meta-analysis. Aesthetic Plastic Surgery, 2019. PMID 31139912. — Significantly lower rates of capsular contracture and haematoma in the subpectoral group, and significantly higher rates of implant displacement and animation deformity; no significant difference in further surgery, seroma, rippling, infection and rupture.

Book your consultation

If you are deciding, the most useful thing you can do with this page is take it to the consultation and ask about your risk: how much of your own tissue you have to cover the implant, which plane and which surface are being proposed and why, and what follow-up will be asked of you. At our practice in Valencia that is explained before anything is decided.

Clinical confirmation by the surgeon

Dr Enrique Salmerón González

Specialist in Plastic, Aesthetic and Reconstructive Surgery
Registration no. 46/4624077

Dr Elena García Vilariño

Specialist in Plastic, Aesthetic and Reconstructive Surgery
Registration no. 46/4624503