The U.S. Food and Drug Administration has recently issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants. Although the initial extensive review suggests that the risk of developing SCC or other lymphomas around breast implants is rare, the FDA states that it wanted to provide clear and understandable information to the public as quickly as possible. In light of this, patients with breast implants should be aware of potential risks and should consult with their healthcare providers if they have any concerns. Additionally, healthcare providers should report any adverse events associated with breast implants to the FDA’s MedWatch program.
For years, breast implants have been viewed as a cosmetic procedure with few risks. However, recent reports have surfaced of patients developing cancer years after receiving implants. In most cases, the cancer presents with symptoms such as swelling, pain, lumps or skin changes. This type of cancer is different from Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which the FDA has been communicating about as a potential risk for more than a decade. While the exact cause of this cancer is unknown, it is important to be aware of the potential risks associated with breast implants. If you have any concerns, be sure to speak with your doctor.
The FDA stated that its work in the area of patient-centered risk communication for these devices has accelerated in recent years, including convening stakeholders to share perspectives that have informed the FDA’s regulatory oversight and implementation of new requirements for manufacturers. The FDA states that it continues to engage top cancer experts and is consulting with its Oncology Center of Excellence to ensure a coordinated approach informed by leaders in the field. Additionally, the agency continues to closely monitor various data sources, such as the scientific literature, adverse event reports submitted to the agency and is soliciting information from manufacturers regarding any reports they may have regarding SCC and other lymphomas related to the tissue around an implant.
It is known that breast implants are not lifetime devices, and that the longer a patient has breast implants, the more likely they will need to be removed or replaced. It is also generally understood that information regarding breast implant risks can be overwhelming for a patient. For this reason, the FDA is encouraging a review of its website with attention to patient labeling, which has easy-to-understand information in the patient brochure.
“Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others. For this reason, instances of SCC, lymphoma and any cancer located in the scar tissue around breast implants should be reported to the FDA,” states Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices. “Our collective understanding has advanced significantly because of the efforts to study, communicate and act when needed. As the agency moves further into adopting modernized approaches to our regulatory responsibilities to promote faster science-based decision-making, accurate data is crucial.
“If a patient with breast implants is experiencing a problem, or there is a case of SCC, lymphoma or any other cancer of the breast implant capsule identified, the FDA strongly encourages reporting this through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Reporting strengthens our ability to work with manufacturers and others to improve safety.”
“[This]afety communication underscores our commitment to sharing the information that we regularly gather and analyze so that patients may fully consider and thoughtfully discuss implant risks with their doctors,” Ashar continued. “We will continue to collaborate with other regulatory authorities, clinical and scientific experts, breast implant registries and patients as a part of our commitment to educate and enhance evidence generation on these potential new risks.
“Looking ahead, the FDA will soon complete a thorough literature review and continue our partnership with the American Society of Plastic Surgeons as we work to identify ways to collect more detailed information regarding patient cases where cancer in the breast implant capsule has been reported. As we learn more about these cases, we hope to better understand the patient risk and communicate findings to the public. ”
“The safety signal issued is an emerging issue that will require steadfast, ongoing evaluation and communication with patients, healthcare providers and manufacturers. We remain committed to informing the public of important and emerging medical device safety risks and appropriately take action on behalf of patients and public health.,” Ashar concluded.
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