By Rebecca Mayo, J.D.
A new draft guidance issued by the FDA provides new labeling recommendations for breast implants that will provide patients with a better understanding of the risks involved in breast augmentation surgery.
As part of the FDA’s effort to protect women’s health, the FDA has issued a new draft guidance that would enhance safety information available to patients considering breast implants. In recent years, the FDA has been made aware of the health risks associated with breast implants and in response convened a public advisory panel meeting and gathered information from patients and stakeholders, according to a press release. Using this information and input, the FDA issued a draft guidance making recommendations concerning the content and format of certain labeling information for breast implant devices (Notice, 84 FR 57028, October 24, 2019).
Risks. The FDA has received new information over the past few years about the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systematic symptoms commonly referred to as breast implant illness (BII). BIA-ALCL is a type of non-Hodgkin’s lymphoma that is most commonly found in the scar tissue and fluid near the implant but can spread throughout the body. BIAA typically presents as fatigue, memory loss, rash, brain fog, and joint pain. The exact relationship of these symptoms with breast implants is unclear at this time but research is ongoing.
Boxed warning. A boxed warning should be part of physician and patient labeling materials that is noticeable and easy to read and understand. The warning for patients should indicate that breast implants are not considered lifetime devices, the chance of developing complications increases over time, some complications may require surgery, and that there is a risk of developing BIAA-ALCL and associated systematic symptoms.
Checklist. A patient decision checklist should be included at the end of the patient information booklet/brochure that highlights key information regarding risks. The checklist should include situations in which the device should not be used, considerations for a healthy implant candidate, risks of undergoing implant surgery, importance of appropriate physician education, training, and experience, risks of BIA-ALCL (including overall rates and rates for the specific manufacturer) and systematic symptoms, and discussion of alternative options other than breast implants. To help ensure that patients read and understand the information in the checklist, the checklist should have a space for patients and physicians to affirmatively acknowledge that specific information was read and discussed.
Rupture screening. Silicone gel-filled breast implant physician and patient labeling should include updated rupture screening recommendations. The guidance provides specific language for both physician labeling and patient labeling that indicates that an ultrasound or magnetic resonance imaging (MRI) should be performed 5-6 years postoperatively and then every 2 years thereafter even if no symptoms are present. If there are symptoms, an ultrasound or MRI are recommended.
Materials. Detailed information about the materials of the construction of the implant shell and filling is publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) for each of the approved implants. However, the FDA recommends that this detailed device description information be included in the patient information booklet/brochure in a format that is understandable to the patient. This is intended to help inform patients of the types and quantities of chemicals and heavy metals that are detected in implants to help them make an informed decision about implantation and the potential adverse effects due to the materials and the potential for rupture, leakage, or diffusion.
Patient device card. A patient device card can be referred to by other names but is a card that is provided to patients immediately following surgery that contains specific information about their device. The FDA recommends that this card include a statement that the card belongs to the patient, the device’s serial number or lot number, the device’s style and size, unique device identifier, boxed warning, and web link access to most current patient decision checklist, boxed warning, and labeling for the specific implant that the patient received.
MainStory: TopStory FDAGuidanceNotices LabelingNews MDeviceNews SafetyNews
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