Domestic/FDA Reports

FDA Statement:

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants:

“…Today, the agency is providing an updated number of medical device reports (MDRs), also known as adverse event reports. After a thorough data analysis, we are reporting that, as of September 2018, the agency has received a total of 660 total medical device reports regarding BIA-ALCL cases since 2010. Of the 660 MDRs, our in-depth analysis suggests that there are 457 unique cases of BIA-ALCL, including 9 patient deaths.

We understand that the information presented shows an increase of 246 new MDRs since last year. Given the agency’s continued efforts to communicate with stakeholders about BIA-ALCL risks and our work to encourage patients and providers to file MDRs with the agency, these types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA. The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis…”

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630895.htm?utm_campaign=020619_Statement_CDRH%20Implant%20Safety%20and%20lymphoma&utm_medium=email&utm_source=Eloqua

Have textured breast implants been recalled in the US?

Not at this time. In 2019, the FDA will convene a meeting of the General and Plastic Surgery Devices Panel at the FDA’s Headquarters in Silver Spring, Maryland, to discuss a range of topics concerning the benefit-risk profile of breast implants. The FDA plans to publish a Federal Register notice and agenda on the FDA’s Advisory Committee Calendar webpage 15 days in advance of the meeting. You can also sign up to receive email updates about all FDA advisory committee meetings. For more information or to sign up for updates:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/default.htm

FDA research and ALCL:

Since 2016, there have been several advances in the description of the disease and treatment recommendations. These are summarized below:The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a unique form of ALCL that can develop following breast implant, implantation. Per the 2016 Revision of the World Health Organization classification of lymphoid Neoplasms, “A number of studies in recent years have identified a unique form of ALK− ALCL arising in association with breast implants designated as breast implant–associated ALCL. First described in 1997, it usually presents as an accumulation of seroma fluid between the implant itself and the surrounding fibrous capsule. Both saline- and silicone-filled implants have been implicated, with a median interval from the time of the implant to the lymphoma of about 10 years. In most cases, the neoplastic cells are confined to the seroma fluid, without invasion of the capsule. In such cases, conservative management is recommended, with removal of the implant and capsule. If there is invasion through the capsule, there is risk of lymph node involvement and systemic spread, warranting systemic chemotherapy. The factors leading to progression have not been delineated.
http://www.bloodjournal.org/content/127/20/2375?sso-checked=true

Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment. Per the Plastic Surgery Foundation website, “ASPS/PSF and FDA are collaborating to conduct research and develop a Breast Implant-Associated ALCL Registry, the PROFILE Registry, to increase the scientific data on ALCL in women with breast implants. The collaboration involves the development of PROFILE and in the proposed research to characterize ALCL in women with breast implants. The Plastic Surgery Foundation website can be found here: https://www.thepsf.org/research/registries/profile.

FDA Warningregarding breast implants:

In January 2011, the FDA issued a Safety Communication on anaplastic large cell lymphoma (ALCL) in women with breast implants. Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. According to the Executive Summary of the report, “Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.”

The 2011 FDA recommendations include, “Consider the possibility of ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected ALCL, refer her to an appropriate specialist for evaluation. When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.

Report all confirmed cases ALCL in women with breast implant to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the reporter’s and the patient’s identity confidential.

Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.

More information can be found here: http://wayback.archive-it.org/7993/20171115053750/https:/www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm

Recommendations regarding breast implants:

The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormalities.

The FDA doesrecommend: Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells).

Additional information is available on the FDA’s Breast Implants website: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/default.htm. Per the FDA, BIA-ALCL appears to develop more frequently in individuals with textured implants than in people with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants.

If you have breast implants, there is no need to change your routine medical care and follow-up. You should expect swelling and pain immediately after surgery. If you notice changes in the way your breast looks or feels after you recover from surgery—including swelling or pain around the implant—be sure to talk to your health care provider about the possibility of BIA-ALCL.

Although not specific to BIA-ALCL, you should follow standard medical recommendations including:
• Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment.

• Follow your doctor’s instructions for routine mammography screening. Be sure to inform the mammography facility that you have breast implants so enough time is scheduled for your mammogram. Your doctor may also recommend other tests, such as magnetic resonance imaging (MRI).

More information can be found here: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm