Breast Implants Recommended for Postmarket Studies

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Committee: General and Plastic Surgery Devices Panel of Medical Devices Advisory Committee

Purpose of the meeting: Public meeting to ensure patients and healthcare providers have continued access to accurate, scientifically sound information

Meeting Information:

Background on Breast Implants:

Following several notable regulatory actions taken by governments worldwide, the agency convened the General and Plastic Surgery Devices Panel for the purposes of discussing the long-term benefits and risk of breast implants for achieving breast augmentation and reconstruction.  Currently, eight breast implants have been approved by the FDA via the premarket approval application process (PMA).  The discussions were broadly centered around the following two categories: 1. identification and characterization of the risks, and 2. risk monitoring and communication.

Risk identification and characterization:

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL):

Post-marketing safety assessment revealed an upsurge in breast implants associated with Medical Device Reports (MDR) in recent years. In 2016, the World Health Organization (WHO) designated BIA-ALCL as a T-cell lymphoma that can develop following breast implants. The agency attempted to determine patient distributions and implant characteristics through MDRs to better understand the disease risk but could not achieve the aim due to sparse data. An effort to capture and characterize BIA-ALCL was made through establishment of the PROFILE registry, however the uptake of cases is low. The panel was asked to make recommendations regarding next steps for the characterization of BIA-ALCL incidents and associated risk factors.

Breast Implant Illness (BII):

Reports have been published that suggested an association between breast implants and systemic symptoms resembling rheumatologic or connective tissue diseases (collectively referred to as BII).  In search of confirmatory evidence, the Agency conducted an elaborate review.  Included in the review was an MDR database search and four manufacture-led, post-approval, long-term follow-up studies. While the collective evidence is indeterminate in establishing association between breast implant and connective tissue disease diagnosis, there are numerous breast implant patients convening on social media to discuss wide variety of symptoms they are experiencing. The FDA therefore asked the panel to discuss methods for assessing and addressing BII symptoms, thereby improving the communication and minimization of the risks, as well as better symptom management in affected individuals.

Surgical mesh for BI:

There are potential risks associated with surgical mesh in breast surgery. The FDA has not evaluated the safety and effectiveness, and the benefits and risks, of surgical mesh in any breast surgery and has not cleared or approved any surgical mesh for use in breast surgery/reconstruction. Therefore the panel discussed evidentiary requirements for assessment of safety/effectiveness and benefits/risks for use of surgical mesh in breast reconstruction/mastopexy procedures.

Risk monitoring and communication:

Silent implant rupture:

The current product labelling of silicone gel-filled implants as recommended by the FDA requires the receiver of the implants to be evaluated by MRI, beginning at 3-years post implantation and every 2 years thereafter.  The American College of Radiology does not recommend imaging evaluation for asymptomatic women of any age.  According to pre-market studies, there is no conclusive evidence that 10 year-rates of rupture differed between MRI and non-MRI monitored groups. Moreover, several reports have challenged the FDA’s monitoring recommendation citing concerns in relation to compliance, cost, and reimbursement.  In light of indicated issues, the panel discussed recommendations of MRI screening for silent rupture of silicone gel-filled implants.

Risk communication/stakeholder involvement:

The FDA recognizes the need to better inform breast implants patients of the risks posed by breast implants, including risks related to implant rupture, BIA-ALCL and systemic symptoms commonly referred to as breast implant illness.  The Agency recognizes the importance for adequate communication of risk and benefit.  The panel was asked to discuss the role and responsibility of all stakeholders in communication with the patients of breast implants.

Next Steps: