Message from your ISAPS President

February, 11th 2019

 

Dear ISAPS Member Surgeon,

French ANSM Hearing Update

On Friday, February 8-9, 2019, the French ANSM conducted an expert panel review regarding the Allergan BioCell texture that is used on breast implants and tissue expanders. This was a two day long hearing with input from various manufacturers, patients, and surgeons. ISAPS was represented by our Board Member Dr. Michel Rouif (France). This was a hearing where the panel of experts at the French ANSM evaluated the safety of this company’s implant texture. Testimony was intense at times as patients discussed their personal experiences with BIA-ALCL and what they call “breast implant illness”.

The US FDA, Health Canada, and the Italian Ministry of Health presented at the hearing:

  • US FDA provided a brief presentation noting the limitations of the BIA-ALCL data (i.e. potential duplication and incompleteness), highlighting the importance of considering benefit/risk of textured implants, and concluding that textured implants should be available as a choice for patients.
  • Health Canada presented a general overview of BIA-ALCL observations from Canadian patients.
  • The Italian Ministry of Health, similar to FDA, discussed the need to preserve texture as a choice to patients and the limitations of the available BIA-ALCL data presented.

The European Commission BIA-ALCL Task Force presented an overview of its scope at the ANSM:

  • The task force will take an evidence based approach to reviewing BIA-ALCL data
  • To date, the preliminary opinion of the majority of EU member states is that „there is insufficient scientific evidence to limit the use of textured breast implants as they provide positive clinical and psychological outcomes for patients.”

French ANSM Expert Committee

Decision February 8-9-2019

The committee’s recommendation to the ANSM said that Allergan BioCell implants should no longer be sold, and that caution should be applied to the use of all roughly textured implants. It said other textured implants remained appropriate for some patients and recommended against preventive explant surgery for patients who already have Allergan BioCell implants.

The politics of this unilateral decision remains to be clarified because the decision to prohibit the sale of BioCell was the sovereign decision of France. The recommendation of the expert committee will be next evaluated by the French ANSM. ISAPS will update its member surgeons when more is known.

US FDA Hearing on Breast Implant Benefit/Risk March 25-26 2019

Other items of interest relate to a notice by the US FDA regarding a public meeting of its General and Plastic Surgery Devices Panel on March 25-26 at the agency’s headquarters in Silver Spring, Maryland, US, to discuss issues and concerns related to the benefit/risk profile of breast implants. FDA plans to post more information and an agenda on the Advisory Committee Calendar web page 15 days prior to the meeting. ISAPS will update its members regarding the possibility that they can submit their opinions to the USFDA.

ISAPS recommends that patients’ concerns about their breast implants be addressed by our member surgeons, who are in the best source for accurate scientific information to answer their questions.

The matter of surface texture and regulatory agencies appears to be evolving over time. ISAPS will update you as we know more.

 

Best regards,

DIRK F. RICHTER, MD, PhD

President