In recent times, there has been a growing concern related to the safety of breast implants. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is one of the major pathologies associated with these implants, especially those are textured
The U.S. Food and Drug Administration had warned women since 2011 about the risk associated with the implants from the available information. Ever since, the FDA has regularly conveyed to the general public about the additional risks associated with breast implants and has been working towards understanding the issues by conducting an in-depth review of-
- Breast implant specific registries
- Scientific literature
- Medical device reports
- Post-market study data
- Public discussions
However, with the ongoing investigation, FDA doesn’t have any actual evidence which demonstrates breast implants to be the cause of BIA-ALCL and other systemic symptoms such as chronic fatigue, cognitive issues, joints and muscle pain. During a public advisory meeting in March 2019, experiences and perspectives of patients, medical and scientific experts, and other stakeholders were recognized. These insights have proven increased efforts to ensure that patient safety is required. On that front, the FDA believes that there is a need for an increase in awareness about the adverse events related to breast implants and textured breast implants.
The following steps have been taken by the FDA to make sure that women are empowered and have the right information regarding breast implants.
- Greater risk of BIA-ALCL and systemic symptoms
- Providing product ingredient information in the labeling
- Educating the medical community including health care professionals
- Regular medical device report updates received about the symptoms experienced by the patients with the implants
- Change in filing medical device reports by the manufacturers which will be publicly available in the Manufacturer and User Facility Device Experience (MAUDE).
- Partnership with registries such as Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE), National Breast Implant Registry (NBIR) which collects real-world data on safety and performance of breast implants.
The key manufacturers have been affected very significantly as the sale of textured breast implants has been put on hold in Europe. Some of these implants have not been given clearance to be sold in the US but the ones currently being sold pose a significant risk to women’s health. Hence, the FDA believes that women should be informed about the adverse events that occur when these implants are used. A robust complaint handling program must be implemented by manufacturers in partnership with regulatory quality experts like Elexes. This will provide all the information needed to analyze and make sound decisions regarding the improvements in usage of breast implants or information to be provided with it for improved patient safety.
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.