Eurosilicone Breast Implants: What Happened and How Patients Were Reimbursed

What is Eurosilicone — and why are patients searching for it?

Eurosilicone is a French breast implant brand owned by GC Aesthetics, the same group behind Nagor. For more than three decades its silicone gel implants — sold under names such as Cristalline, Round, Paragel and various anatomical lines — were CE-marked and widely used across Europe, the UK, Latin America and the Middle East.

Over the last few years, however, a number of Eurosilicone patients have been told their device is subject to a recall, a regulator's safety notice, or a manufacturer warranty claim. This guide explains, in plain language, what actually happened, which patients are affected, and — most importantly — how reimbursement and replacement have worked in practice.

The 2019 ANSM decision: a textured-implant issue, not a PIP-style scandal

Eurosilicone is often confused with the 2010 PIP (Poly Implant Prothèse) scandal. They are not the same. PIP involved unauthorised industrial-grade silicone and led to a French government-funded explant programme. Eurosilicone implants use medical-grade silicone and have never been the subject of a fraud finding.

The Eurosilicone safety issue is narrower and more recent. On 2 April 2019, France's medical-device regulator ANSM ordered the withdrawal from the European market of macro-textured and polyurethane-coated breast implants, citing a higher reported risk of BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) — a rare cancer of the immune cells in the capsule around the implant.

This decision affected several manufacturers, including Allergan's Biocell line and certain Eurosilicone CMC (Cell Micro Contact) textured shells. Smooth-surfaced Eurosilicone implants and most lower-texture lines were not withdrawn and remain available.

What is BIA-ALCL — and how big is the risk?

BIA-ALCL is not breast cancer. It is a T-cell lymphoma that develops in the fluid or scar capsule around a textured implant, typically 8–10 years after surgery. The most common warning sign is a late-onset, painless seroma (swelling) in one breast.

The absolute risk remains low — published estimates range from roughly 1 in 3,000 to 1 in 30,000 depending on shell type — and the disease is highly curable when caught early and treated with full capsulectomy. Smooth implants have not been associated with BIA-ALCL.

How patients have actually been reimbursed

There is no government reimbursement scheme for Eurosilicone implants comparable to the French state's PIP programme. Reimbursement instead runs through the manufacturer's own warranty — and, in some healthcare systems, through national insurance.

1. The GC Aesthetics ConfidencePlus warranty

Every Eurosilicone implant sold since the programme launched carries the ConfidencePlus warranty. For affected patients it provides three things:

• Free lifetime replacement of the device in cases of confirmed rupture, Baker grade III/IV capsular contracture, or BIA-ALCL.
• Financial assistance toward surgical and anaesthetic costs — historically up to €1,000 per breast for rupture and contracture, and a higher contribution for confirmed BIA-ALCL cases.
• Free contralateral implant so the unaffected side can be exchanged at the same time and a symmetrical result preserved.

The warranty is activated by registering the implant's lot and serial number — printed on the patient implant card issued at the time of surgery — through the GC Aesthetics website or via the implanting surgeon.

2. National health-system coverage for explantation

Following the 2019 ANSM decision, several European systems agreed to cover explant surgery (removal, with or without replacement) when clinically indicated:

• France: the social security system reimburses explantation of a withdrawn textured implant when a clinical reason exists, even prophylactically in selected cases.
• United Kingdom: the MHRA did not order a recall, but the NHS will fund explant surgery where a patient develops complications such as suspected BIA-ALCL, rupture, or severe capsular contracture.
• Spain, Italy, the Netherlands: public systems cover removal in symptomatic patients; cosmetic re-augmentation typically remains private.

3. The combined real-world pathway

In practice, an affected patient usually receives:

• The new implants free of charge from GC Aesthetics under ConfidencePlus,
• A cash contribution toward theatre and surgeon fees from the same warranty,
• And, where the country's system allows, public coverage of the surgical episode itself.

The out-of-pocket cost to the patient is often reduced to zero or to a small private-clinic supplement.

How to check if your implants are affected

1. Find your implant card. Every patient is given one after surgery. It lists the manufacturer (Eurosilicone or GC Aesthetics), shell type (smooth, micro-textured, CMC textured), lot number and serial number.
2. Check the surface type. Only macro-textured and polyurethane shells were withdrawn in 2019. Smooth and many micro-textured devices are not affected.
3. Register on the manufacturer portal. GC Aesthetics' ConfidencePlus registration will confirm whether your serial number is covered and what benefits apply.
4. Book a clinical review. An ultrasound or MRI is the only way to confirm rupture or seroma. International guidelines recommend an MRI at 5–6 years after surgery and every 2–3 years thereafter for silicone implants.

When should I see a surgeon urgently?

Make an appointment promptly if you experience any of the following with a textured Eurosilicone (or any textured) implant:

• New, painless swelling in one breast more than a year after surgery,
• A firm, painful, distorted breast suggesting capsular contracture,
• A palpable lump in the breast or armpit,
• Persistent skin changes, rash, or ulceration over the implant.

These symptoms are usually not BIA-ALCL — but they need imaging and, if a seroma is found, a simple needle aspiration sent for CD30 testing to rule it out.

Should every Eurosilicone patient have their implants removed?

No. The international consensus — shared by ANSM, the FDA, the MHRA and the major plastic surgery societies — is that asymptomatic patients with textured implants do not need prophylactic removal. The risk of complications from surgery in a well patient is higher than the absolute risk of BIA-ALCL.

What patients do need is honest information, a clear surveillance plan, and a surgeon who will perform a full capsulectomy and en-bloc removal if and when the time comes.

How we handle Eurosilicone cases at the clinic

At our Istanbul practice we regularly see international patients whose original surgery was performed elsewhere with a Eurosilicone device. Our standard pathway is:

• A full review of the implant card and operative notes,
• High-resolution ultrasound and, where indicated, breast MRI,
• Coordination with GC Aesthetics ConfidencePlus on the patient's behalf to secure replacement implants and the financial contribution,
• Where clinically required, en-bloc capsulectomy through a tension-free incision using the same atraumatic techniques developed for the K-Glide and Twirl Internal Bra protocols,
• Reconstruction with a smooth, modern device — or autologous fat — according to patient preference.

Key takeaways

• Eurosilicone is a legitimate, medical-grade implant brand — not the PIP scandal.
• In 2019, ANSM withdrew macro-textured and polyurethane Eurosilicone lines over a small but real BIA-ALCL signal.
• Reimbursement runs through the manufacturer's ConfidencePlus warranty: free replacement implants plus a financial contribution toward surgery, and, in many countries, public-system coverage of the operation itself.
• Asymptomatic patients do not need preventive removal, but should follow an imaging schedule and act on any late swelling.
• A surgeon experienced in capsulectomy and BIA-ALCL work-up should always lead the review.

This article is intended as general patient education and is not a substitute for individual medical advice. Patients with concerns about a specific implant should consult their implanting surgeon or an appropriately qualified plastic surgeon, and the regulator in their country of residence.