Hard lumps under the skin around the implant. The breasts are uneven in appearance in terms of size, shape or breast level. These complications are listed alphabetically, not in order of how often they occur. ![]() You may need non-surgical treatments or additional surgeries to treat any of these, and you should discuss any complication and necessary treatment with your doctor. The following is a list of local complications and adverse outcomes that occur in at least 1 percent of breast implant patients at any time. Connective tissue disease, breast cancer, and reproductive problems.Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma (cancer of the immune system).Capsular contracture, scar tissue (capsule) that forms around the implant and squeezes the implant.Additional surgeries, with or without removal of the device (also see Implant Removal Options).Implant complications, such as breast pain and changes in nipple and breast sensation.Some of the complications and adverse outcomes of breast implants include: Lastly, the FDA released updated information on the status of breast implant manufacturer post-approval studies. The breast implant manufacturers have posted the updated device labeling to their websites. Device description with a list of specific materials in the device.Updated silicone gel-filled breast implant rupture screening recommendations.The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device.Second, the FDA approved new labeling for all legally marketed breast implants that includes: On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.įirst, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. ![]() FDA Strengthens Breast Implant Safety Requirements and Updates Study Results
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