The ANSM now advises surgeons not to use breast implants with a textured envelope. These materials have been linked to the development of anaplastic large cell lymphoma, a rare and aggressive cancer.
In the event of aesthetic or reconstructive surgery of the breasts, the use of breast implants with a textured envelope is now not recommended by the ANSMwhich recommends that healthcare professionals preferably use breast implants with a smooth shell.
“In addition to the investigations currently being carried out by the European health agencies, the ANSM considers that it is necessary, before taking a decision concerning the use in particular of breast implants with a textured envelope, to question the stakeholders on the of these implants in reconstructive and aesthetic surgery,” the public health agency said in a statement. “Thus, any citizen, representing patients or not, health professionals, learned societies of aesthetic surgery and senology, oncology, universities, institutions or companies marketing breast prostheses can ask to be heard (see here)”.
A rare and aggressive cancer
Christian Marinetti, whistleblower of the PIP scandal and plastic surgeon, accused last September the model of textured breast prostheses “Biocell” cause anaplastic large cell lymphoma.
Anaplastic large cell lymphoma (ALCL) is a peripheral T-cell non-Hodgkin lymphoma. It is a rare and aggressive cancer, affecting the lymph nodes and organs. “Let us monitor, even more closely than the others, the patients having Biocell. As with a drug, the prostheses have side effects. This one is serious, but rare. The risk is low, but now that we know it, we are obliged to take this into account,” said the specialist.
53 cases of anaplastic large cell lymphoma
53 cases of anaplastic large cell lymphoma have been associated with breast implants (ALCL-AIM) declared to the ANSM between 2011 and July 2018. Among these 53 patients, five died, three of which were linked to progression of ALCL. For the other two patients, imputability remains uncertain. The average age of the patients at the time of diagnosis was 58.4 years (minimum: 29 years; maximum: 83 years). The average duration of implantation between the last implanted breast prosthesis and the diagnosis of ALCL is 7 years, with a minimum of 3 months and a maximum of 25 years of implantation on the last breast prosthesis.
“The one that gives the most lymphoma problems is Allergan’s Biocelle”, explains Christian Marinetti. Its grainy appearance, designed to adhere better to the breast, is thought to be the cause of lymphoma. “She has allowed lots of women who have had breast cancer, who have had their breasts amputated, to regain a normal physical appearance”, however nuances the whistleblower, who does not plan to proscribe these breast implants . It would be up to the surgeons “to assess in the field what are the advantages or disadvantages of using this or that type of implant in the interest of the patient”, he specifies.
Autoimmune diseases
Suspicions about Allergan branded products are not new. It was in March 2015 that the National Cancer Institute (INCa) and the ANSM lifted this hare. In July 2016, 29 cases of lymphoma associated with breast implants had already been reported in France. A recent study published in Annals of Surgery also indicates that women with silicone breast implants are more at risk of developing autoimmune diseases and skin cancers.
Compared to saline-filled implants, silicone implants are also linked to a higher risk of surgical complications. These include capsular retraction (scarring around the implant), which occurs with 5% of silicone implants compared to 2.8% with saline-filled implants.
“Practitioners are required to inform patients”
In this context, the ANSM will convene on February 7 and 8, 2019 a committee of experts responsible for interviewing patients, healthcare professionals and other actors concerned to benefit from an overall perspective on the use of these implants. At the end of these hearings and the opinion of the committee of experts, a decision will be taken concerning “the use in particular of breast implants with a textured envelope, in aesthetic and reconstructive surgery”, specifies the organization.
In the meantime, “practitioners are required to inform patients before the placement of breast implants of the risks associated with the surgical procedure but also on the implant itself, in particular the risks associated with ALCL”, recalls the ‘agency.
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