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Plastic Surgery Blog

FDA Finds that Breast Implants are Safe and Effective

FDA

 We have discussed in earlier blogs the concerns that some people have about the link between Anaplastic large cell lymphoma (ALCL) and breast implants. This past March the Food and Drug Administration Advisory Committee met to discuss BIA-ALCL and other topics related to implants. This month the FDA announced that it judges all breast implant options safe and effective. Here we will talk about their conclusions.

The FDA has an enormous responsibility to monitor across industries and determine if the products or devices that manufacturers, food processors, pharmaceutical companies, and other companies produce are in any way harmful to the health of the public who purchase or otherwise have access to them. They have been monitoring the safety of breast implants for decades through information gleaned from scientific studies, medical device reports, scientific literature, as well as direct input from breast implant experts and women who have had breast implants.

FDA Conclusions

Having examined both data and personal experience, the FDA announced its conclusion this month. It said that all breast implant options are effective and safe and will be allowed to remain available to consumers in the United States. The FDA stated, "At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act."

Panel experts from the meeting acknowledged that board certified plastic surgeons have the best understand and experience with breast implant products and patients. In addition, the FDA stated they would be exploring the following actions in order to better inform women who are considering breast implants of the potential risks:

  • Updating the device labeling which may include a boxed warning and a patient decision checklist in order to ensure patients are fully informed of potential benefits and risks;
  • Educating the pathology community further about testing for BIA-ALCL;
  • Continuing updates about global medical device reports for BIA-ALCL;
  • Communicating information the agency receives about systemic symptoms experienced by patients with breast implants;
  • Researching the broad array of systemic symptoms that have been mentioned as potentially associated with breast implants;
  • Updating summary reporting for breast implant manufacturers to submit individual medical device reports that will be publicly available in Manufacturer and User Facility Device Experience (MAUDE); and
  • Partnering with registries that collect real world data on breast implants, and encouraging stakeholders to expand participation.

This is not the final word from the Food and Drug Administration about breast implants, but it is the most up to date. They intend to continue to work to educate, liaise, research, and communicate to the public any new findings about breast implant safety as new information comes out.

Bancroft Feldman and Dr. Feldman as a breast expert are equally committed to informing our patients of all risks and possible outcomes of breast augmentation. We want to be transparent about the work we do. We are proud of our successes and the satisfaction of our patients. If you are considering getting breast implants but have questions, do not hesitate to ask either our staff or Dr. Feldman during your initial consultation. We want you to be happy with your new breasts and have the peace of mind you need to fully enjoy them.



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