Statement: As a precautionary measure, the ANSM (French National Agency for the Safety of Medicines and Health Products) has decided to recall macrotextured breast implants and breast implants with a polyurethane-coated surface. The ANSM does not recommend preventive removal for women with these implants.
Since the first cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) appeared in 2011, the French National Agency for the Safety of Medicines and Health Products (ANSM) has carried out numerous investigations to study the link between the occurrence of BIA-ALCL cases and breast implant texture. Based on all the information available to it, including opinions from independent experts, the ANSM considers that the texturing of certain macrotextured implants and polyurethane-coated implants constitutes a risk factor in the occurrence of BIA-ALCL.
The ANSM has therefore decided, as a precautionary measure, to recall these implants in order to reduce women's exposure to the risk of BIA-ALCL, which remains a rare but serious risk. Given the rarity of this risk, the ANSM does not recommend preventive removal for women with these implants.
The ANSM has set up a toll-free number, 0.800.71.02.35 (France), to answer patients' questions. Patients are also invited to consult a healthcare professional for any further questions.
Since 2011, 59 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) have been reported in France. In 2017, the number of women with breast implants in France was estimated at 400,000.
To investigate the risk of BIA-ALCL associated with breast implants, the ANSM carried out ongoing monitoring of device-related reports and brought together numerous stakeholders, including, recently, a panel of experts (CSST) who, on February 7 and 8, 2019, heard from patients, healthcare professionals, European and international health authorities, and manufacturers, in order to issue an opinion on the place of textured breast implants in cosmetic and reconstructive surgery.
The CSST expert panel issued its opinion on February 8, 2019, recommending in particular: "In the context of the ANSM's recommendation to preferentially use smooth implants, and given the doubts raised by healthcare professionals, the use of Allergan's Biocell texture should be prohibited. The greatest caution should be exercised with breast implants of equivalent texture and with polyurethane implants. The committee does not, however, recommend preventive removal of these textured implants."
In light of this opinion and all the information available to it, the ANSM considers that the more textured and rough an implant is, the greater the risk of BIA-ALCL. The ANSM has therefore decided, as a precautionary measure, to recall from the market certain macrotextured implants with a texture equivalent to Allergan's Biocell shell, as well as polyurethane implants, in order to reduce women's exposure to the risk of BIA-ALCL, which remains a rare but serious risk.
This precautionary measure aims to prohibit the marketing, distribution and use of this type of breast implant, as well as their withdrawal from the French market. The ANSM's decision took effect on April 5, 2019.
The ANSM reiterates its recommendation to preferentially use smooth breast implants in cosmetic or reconstructive surgery.
Given the rarity of the risk of BIA-ALCL and the CSST's opinion, the ANSM does not recommend preventive removal of macrotextured implants or implants with a polyurethane-coated surface.
Furthermore, as recommended by the CSST, the ANSM wishes to reiterate the importance of providing rigorous and complete information to women wishing to have breast implants. The patient and the surgeon should discuss together the advantages and disadvantages of the various implants available, as well as alternative techniques in cosmetic surgery or breast reconstruction following cancer.
A document specifying, in particular, the identification of the implant's surface (smooth, microtextured, etc.), its limited lifespan and the possible need for a follow-up procedure as a result, as well as the required medical follow-up, must be given to all women prior to breast implant placement.
Information for patients
In accordance with the INCa expert opinion of February 2019 on BIA-ALCL:
- In the presence of functional or physical signs (significant peri-prosthetic effusion, increase in volume, pain, inflammation, mass, ulceration, general deterioration) occurring, in particular, well after the post-operative phase, in a woman with a breast implant, a diagnosis of BIA-ALCL should be considered.
- For women with a breast implant and no clinical signs affecting the breasts, the expert panel recommends the usual follow-up: annual clinical breast examination and any appropriate radiological imaging.
- Healthcare professionals responsible for this follow-up (general practitioners, surgeons, oncologists, gynecologists, radiologists, midwives, etc.) should be informed of and made aware of the local signs that may be associated with the occurrence of BIA-ALCL.
The ANSM maintains its heightened surveillance of breast implants and continues its investigations. The ANSM is calling, along with the CSST expert panel, for the national breast implant registry, whose creation has just been approved, to be set up promptly.
Learn more:
> View the list of implants concerned
> Information sheet "Breast implants and prostheses: cosmetic breast surgery"
