On October 24, 2019, the FDA issued “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication” containing recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The FDA stated that it was issuing its draft guidance “to help ensure that a patient receives and understands the benefits and risks of these devices. The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of these devices.”
Breast implants are medical devices implanted under the breast tissue or chest muscle to increase breast size (augmentation) or to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery. The use of breast implants in reconstructive and augmentation procedures is elective, and alternatives to the use of breast implants exist (such as an external breast prosthesis).
There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Saline-filled breast implants are inflated to the desired size with sterile isotonic saline. Silicone gel-filled breast implants contain a fixed volume of silicone gel. Silicone gel viscosity differs among implants and manufacturers.
Breast implants are manufactured with smooth and textured surfaces. The outer surface, or “shell” for both types of breast implants is manufactured from polysiloxane silicone rubber and may vary in shell surface, shape, profile, volume, and thickness. For breast implants with a textured shell surface, each breast implant manufacturer utilizes a proprietary manufacturing process to create the textured surface, which means that each manufacturer’s textured shell is different.
Over the past few years, FDA has received new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms commonly referred to as breast implant illness (BII) that some patients attribute to their implants. BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. An individual’s risk of developing BIA-ALCL is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly.
The FDA recommends that the patient labeling for breast implants include a patient information booklet/brochure, patient decision checklist, boxed warning, and patient device card. Specifically, the FDA believes manufacturers should include a boxed warning and patient decision checklist to help ensure patients receive and understand information about the benefits and risks of breast implants. The FDA recommends the patient information booklet/brochure also include a detailed device description of the materials of construction of the breast implant shell and filling in a format that is understandable to the patient.
The FDA recommends that a boxed warning generally inform patients that:
· The chance of developing complications increases over time;
· Some complications will require more surgery; and
· Breast implants have been associated with the risk of developing BIA-ALCL and may be associated with systemic symptoms.
The FDA also believes that a patient decision checklist highlighting key information regarding risks should be included at the end of the patient information booklet/brochure. The FDA recommends that the body of the checklist include the following:
· Situations in which the device should not be used or implanted;
· Considerations for a successful breast implant candidate;
· Risks of undergoing breast implant surgery;
· Importance of appropriate physician education, training and experience;
· Risk of BIA-ALCL and systemic symptoms; and
· Discussion of options other than breast implants.
The FDA also encourages device manufacturers to develop a plan to ensure that patients are adequately informed of the risks of breast implants and breast implant surgery, to update the checklist as additional data is collected with post-market experience, and to provide a dedicated website link for each device that allows providers involved in the care of breast implant patients and patients with that specific breast implant to regularly monitor changes to the patient decision checklist, boxed warning, and product label.The FDA specifically recommends that the rates of BIA-ALCL included in the patient decision checklist reflect current information based on estimated incidence rates. These rates include overall incidence rates of BIA-ALCL, as well as rates for the manufacturer’s specific breast implant based on published literature, registries, and medical device reports.
The FDA also updated its rupture screening guidance:
For asymptomatic patients, the first ultrasound or magnetic resonance imaging (MRI) should be performed at 5-6 years postoperatively, then every 2 years thereafter.
For symptomatic patients or patients with equivocal ultrasound results for rupture at any time postoperatively, an MRI is recommended.
Even if the patient has no symptoms, the patient should have her first ultrasound or MRI at 5-6 years after her initial implant surgery and then every 2 years thereafter. If the patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.
If you or a loved one have a breast implant and suffered injury, you should promptly contact us by clicking on this link or by calling us toll-free in the United States at 800-295-3959, to find breast implant lawyers who may answer your questions and represent you in a claim, if appropriate.
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