Borstimplantaten - reactie fabrikant Allergan

'For questions related to the withdrawal of Allergan implants, I would direct you to our press release issued in December.

For questions related to the ANSM hearing and other topics, below please find our statement:
 
“Allergan welcomed the opportunity to have our voice heard during the ANSM hearing on textured breast implants as the presenting representative on behalf of all manufacturers that are members of SNITEM. It provided us the chance to put forward a balanced position on the benefit/safety risk profile of textured breast implants and their important place in medical care for patients seeking options for reconstructive or aesthetic procedures.
 
Allergan has also submitted a written statement to the ANSM which outlines our specific position on the safety and medical need for textured breast implants, as well as additional steps that can be taken by the plastic surgery community to improve understanding, identification and diagnosis of adverse events related to textured breast implants. We look forward to the outcome of the hearing held February 7 & 8 in France. We cannot provide further comment until we know ANSM’s decision and next steps.
 
Patient safety and product quality are Allergan’s highest priorities. We are committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards for our products.
 
Allergan stands behind the benefit/risk profile of our breast implant products. Surgeons need a variety of implant types to address the variable nature of breast anatomy and pathology with each patient. All devices should have a positive benefit risk profile and the benefit risk profile of textured implants is positive. Allergan actively supports research, education and informative labelling to promote and advance the safest use of textured devices.
 
The safety profile of Allergan’s breast implants is supported by extensive pre-clinical and clinical data, more than a decade of successful U.S. and European clinical use as well as a large number of peer-reviewed and published studies.
 
Patients are advised to have a thorough discussion with their plastic surgeon about the risks and benefits of each implant type to make a fully informed decision.
 
Global regulatory authorities have continuously evaluated case reports of Breast Implant-Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) and acknowledge that the known cases represent an uncommon occurrence of the condition in the population of patients with textured breast implants. Allergan is and has been fully committed to investing in and supporting work to further understanding and increasing awareness of BIA-ALCL.
 
Allergan is, and has been, fully committed to investing in and supporting work to further understanding and increasing awareness of BIA-ALCL.  While these efforts to enhance understanding and awareness are ongoing, we continue to support the needs of patients and their surgeons.'