Breast implant lymphoma at a glance
- Cases in France121 (ANSM, end of 2024)
- Cases worldwide1,380 (FDA, mid-2024)
- Implants in place for13 years on average
- Implants concernedTextured
- Main signA breast that swells
- Preventive removalNot recommended
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a very rare cancer of the immune system, which develops in the capsule surrounding the implant. It is not breast cancer. It generally appears several years after the implants are placed, most often as a swelling of the breast caused by a collection of fluid around the implant. It concerns almost exclusively textured implants, especially macrotextured ones: in France, these have been banned since April 2019. When treated early, it is usually cured by removing the implant and its capsule. The ANSM (French National Agency for the Safety of Medicines and Health Products) does not recommend removing implants in the absence of symptoms.
Article from 2015, updated with data from the ANSM (2025) and the FDA (2024).
What is BIA-ALCL?
It is a lymphoma, that is, a cancer of certain cells of the immune system (T lymphocytes), which develops in contact with the implant, in the fluid or the membrane (capsule) surrounding it. It is not breast cancer, which develops from the mammary gland. The filling of the implant (silicone gel or saline) is not the cause.
Normal implant: a thin membrane, the capsule (2), always surrounds the implant (1).
- 1Implant
- 2Capsule
- 3Fluid around the implant (seroma)
- 4Lump in the capsule
Is it common?
No, it is a very rare disease. The ANSM has recorded 121 cases in France between 2011 and 31 December 2024. Worldwide, the FDA (the US health authority) had received 1,380 case reports as of 30 June 2024, including 64 deaths. These figures do not allow a precise individual risk to be calculated, because the number of women with implants is not known exactly.
Which implants are concerned?
The risk is linked to the surface of the implant. In the French cases analysed by the ANSM, 86% of the implants in place at the time of diagnosis were textured, 3% were polyurethane-coated, and none were smooth (the surface was unknown for the others). Two thirds were Allergan implants (McGhan, Inamed). Worldwide, almost all cases have occurred with textured implants or in women who had previously had them.
Implant texturing was developed for two reasons: some studies showed less capsular contracture than with smooth implants, and macrotexturing prevented anatomical implants from rotating by gripping the tissues.
The implants Dr Médard de Chardon uses today are smooth, microtextured or nanotextured.
Why are macrotextured implants banned in France?
By a decision of 2 April 2019, effective on 5 April 2019, the ANSM withdrew from the French market, as a precaution, macrotextured implants (texture equivalent to Allergan’s Biocell texture) and polyurethane-coated implants, considering their texture to be a risk factor for BIA-ALCL. In July 2019, Allergan recalled its Biocell implants worldwide, at the request of the FDA. Since then, the share of smooth implants placed in France has risen from 13% (2007-2016) to 62% (2024).
What are the causes?
No single cause has been identified. The accepted hypothesis is multifactorial: a heavily textured surface, chronic inflammation linked to bacteria in contact with the implant, and a genetic predisposition.
What are the signs?
The most common sign is a swelling of the breast, several years after the implants were placed, caused by a collection of fluid around the implant (late seroma). In the French cases, the implants had been in place for 13 years on average (from 4 to 42 years). More rarely, the lymphoma appears as a lump in the breast or armpit, a hard area, pain, redness, ulceration or severe fatigue.
I have implants: what should I do?
In the absence of symptoms, nothing more than the usual monitoring for anyone with implants:
- regular self-examination of your breasts;
- an annual clinical examination by your plastic surgeon or your gynaecologist;
- imaging (ultrasound, mammography, MRI) as recommended by your surgeon.
See your plastic surgeon without delay if one breast increases in size, or if you notice a lump in the breast or armpit, pain, inflammation, ulceration or a deterioration in your general health.
Should macrotextured implants be removed?
No. The ANSM does not recommend preventive removal for women with macrotextured or polyurethane-coated implants, and no professional society recommends it: the risk is very low. Normal monitoring is sufficient. If you nevertheless wish to have them changed, the decision is discussed in consultation.
How is it diagnosed?
There is no blood test to screen for this lymphoma. If there are suggestive signs, the plastic surgeon carries out an assessment:
- clinical examination of the breasts and lymph nodes;
- ultrasound and, if necessary, MRI;
- ultrasound-guided aspiration of the fluid around the implant, analysed for CD30+ and ALK− lymphoma cells, with review by the Lymphopath network [Note: French national pathology review network for lymphomas].
How is it treated?
At an early stage, treatment is surgical: removal of the implants and complete removal of the capsule surrounding them (total capsulectomy), on both sides. If the disease has spread to the lymph nodes or neighbouring tissues, chemotherapy or radiotherapy may be needed; these advanced forms are rare.
Choosing a qualified, experienced and reputable surgeon reduces these risks, and in some cases eliminates them.
Frequently asked questions
Is BIA-ALCL a breast cancer?
No. It is a lymphoma, a cancer of immune system cells, which develops in contact with the implant and not in the mammary gland.
Are smooth implants concerned?
Only very exceptionally. In the French cases, none of the implants in place at diagnosis was smooth; worldwide, the rare cases described with a smooth implant often involve women who had previously had a textured implant.
Is silicone gel the cause?
No. The risk is linked to the surface of the implant, not to its contents.
Should I have my textured implants removed?
No, not in the absence of symptoms: the ANSM does not recommend preventive removal. The usual monitoring is sufficient.
Which sign should raise concern?
A breast that swells several years after the implants were placed, or a lump in the breast or armpit: see your plastic surgeon.
Can this lymphoma be cured?
Yes, in most cases, when it is treated early: removing the implant and its capsule is then generally sufficient.
Sources
- ANSM. Analysis of cases of breast implant-associated anaplastic large cell lymphoma since 2011. November 2025 (data as of 31 December 2024).
- ANSM. Decision of 2 April 2019: withdrawal from the market of macrotextured breast implants and polyurethane-coated implants.
- FDA. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (data as of 30 June 2024).
- INCa (French National Cancer Institute). Expert report on breast implant-associated anaplastic large cell lymphoma, 2015.
See also: breast augmentation · anatomical implants · capsular contracture.