Update: Stronger guidance about breast implant safety
|At a glance||What does this mean for me?|
|Patient decision checklist||Questions for your doctor|
|Rupture screening recommendations||Resources|
|Patient device card|
UPDATE AT A GLANCE
What is this update about?
The released new guidance on saline and silicone breast implant labeling, patient communication and informed consent on October 27, 2021. The updated guidelines recommend that implant manufacturers incorporate what’s known as a “black box warning” and a decision checklist into information brochures given to patients. It also provides updated implant rupture screening recommendations.
Why is this update important?
Many people have breast implants for reconstruction or cosmetically to alter breast size. This boxed warning is intended to ensure that all people with breast implants have the appropriate information to understand and make decisions about their healthcare.
Update in brief
An “boxed warning” (also called a “black box warning”) alerts people to serious or life-threatening risks from a drug or device. The is requiring that a boxed warning be included as part of physician and patient materials for breast implants. The agency believes that this warning will be useful in communicating identified breast implant risks. The boxed warning will inform patients that:
- breast implants are not considered lifetime devices and may require replacement;
- the chance of complications increases over time;
- some complications require more surgery;
- textured breast implants have been associated with the development of a rare cancer of the immune system called breast implant-associated anaplastic large cell (BIA-ALCL);
- breast implants have been associated with a variety of symptoms in some women (known as breast implant illness or BII). See our XRAY review of this issue for more information.
Patient Decision Checklist
The now requires implant manufacturers to include a patient decision checklist that highlights key information regarding the potential risks of having breast implants. This added information is to appear at the end of the information booklet/brochure that should be given to everyone who is considering breast implants. Surgeons must review this checklist with their patients to help ensure that they understand the risks, benefits and other information about breast implants. The patient must be given the opportunity to initial and sign the patient decision checklist, which must also be signed by the physician implanting the device.
The checklist covers:
- situations in which breast implants should not be used;
- considerations for successful breast implant candidates;
- the risks of undergoing breast implant surgery;
- the importance of appropriate physician education, training and experience;
- the risk of BIA-ALCL;
- the risk of systemic symptoms;
- discussion of options other than breast implants, as appropriate.
"It is recommended that you have periodic imaging (e.g., , ) of your silicone gel-filled breast implants to screen for implant rupture regardless of whether your implants are for cosmetic augmentation or reconstruction. These recommendations do not replace other additional imaging that may be required depending on your medical history or circumstances. Even if you have no symptoms, you should have your first or at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain results for breast implant rupture, an is recommended."
Previous guidelines recommended screening silicone breast implants for a rupture with a breast 3 years after the initial implant surgery and every 2 years after that. The new guidelines reflect research indicating that ruptures are more likely to occur 6 years after silicone devices are implanted. Breast is a less costly alternative to breast MRIs.
Patient Device Card
Patient device cards provide patients with unique information about their breast implants. Patients should receive this card immediately following surgery. The device card should include the following information:
- the serial or lot number of the device;
- the style and size of the device;
- the Unique Device Identifier (UDI);
- a web link to access the most current patient decision checklist, the box warning and labeling for the specific implant received by the patient;
- a statement that “There is a boxed warning for breast implants, see web link”;
- a toll-free phone number to contact the breast implant manufacturer.
If you get breast implants in the future, you should receive a Patient Device Card that provides specific information about your implants immediately after surgery. If you already have breast implants and do not know which type of implant you have, you may want to request this information from the physician who performed your implant surgery.
If you already have breast implants, it is important to know that they are not lifetime devices, and at some point, you may need to have them removed or replaced. The recommends regular imaging (e.g., , ) of your silicone gel-filled breast implants to monitor for implant rupture. (Imaging of saline implants for rupture isn’t required). Even if you have no symptoms, you should have your first or at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain results for breast implant rupture, an is recommended.
Complications, although rare, may arise long after your initial surgery. Textured implants are linked to a rare type of called BIA-ALCL. Some people with breast implants have experienced systemic symptoms known collectively as breast implant illness or BII.
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Federal Drug Administration, Breast Implants: Strengthens Breast Implant Safety Requirements and Updates Study Results. Published online October 27, 2021.
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
People with or considering breast implants
This article is also relevant for:
people with breast cancer
people with metastatic or advanced cancer
people newly diagnosed with cancer
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The issued guidelines for use of breast implants:
- Breast implant manufacturers are required to include a label warning and a patient decision checklist with all implants:
- The checklist should include the current incidence rates of breast implant-associated anaplastic large cell (BIA-ALCL) and breast implant illness (BII).
- The checklist should also include specific information regarding ongoing patient registries.
- The has provided breast implant manufacturers specific language for an informational card that should be given to all patients following placement of breast implants. The card should include:
- the serial number, lot number, device style, device size and the unique device identifier (UDI) of the implant.
- weblinks to the most up-to-date access to the patient device checklist, boxed warning and labeling of the specific implant.
- In collaboration with the and breast implant manufacturers, the American Society of Plastic Surgeons and the Plastic Surgery Foundation launched the National Breast Implant Registry (NBIR) in September 2018. The purpose of this database is to collect information from plastic surgeons on breast implant procedures to help improve the quality of care for all patients.
- What are the risks and benefits of breast implants?
- What symptoms should I be aware of regarding my breast implants?
- How long will my breast implants last?
- Under what circumstances should I consider removing or replacing my breast implants?
The following are studies related to breast reconstruction or no reconstruction after mastectomy.
- NCT04533373: Sensory Restoration After Flap Neurotization. The goal of this study is to look at how well a nerve graft works for improving sensation to the reconstructed breast after mastectomy in people undergoing flap reconstruction.
- NCT04491591: Implementing BREASTChoice Into Practice. Breast reconstruction after mastectomy is a highly personal decision. A clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. This study will evaluate whether BREASTChoice assists reconstruction decisions.
- NCT04293146: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC. This study will compare the effect of under-the-muscle versus over-the-muscle reconstruction on quality-of-life outcomes.
NCT05020574: Microbiome and Association With Implant Infections. The study is looking at whether people with high amounts of certain types of bacteria are more likely to develop tissue expander-related infections than those with lower amounts of bacteria.
Who covered this study?
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American Society of Plastic Surgeons
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