Breast Implant Surveillance And ALCL Information

Monitoring

  • Breast Implants are not considered lifetime devices. The longer patients have them, the greater the chances are that they will develop problems, some of which will require more surgery.
  • While there is no “10 year rule,” it is certainly reasonable to suggest breast implant patients who have not been seen by their plastic surgeon in five to ten years come in for an exam. Patients can also request additional surgeries to modify the aesthetic outcome, such as size or shape.
  • The FDA recommends that patients with silicone implants get MRI or ultrasound screenings to detect silent ruptures six years after their surgery and every three years after that.
  • Surgeon performed ultrasound is a valuable addition to physical exam to assess the condition of implants.  Dr. Wigod has been an early adopter of Plastic Surgeon performed Ultrasound and provides this service to his patients.
  • Patients should continue to have mammograms at least as often as recommended by the U.S. Preventative Services Task Force or as advised by their primary care provider. Mammogram guidelines have evolved over time and may be expected to continue changing.

Breast Implant Illness – The Science

  • Authoritative review of scientific knowledge to date has failed to find any evidence based study to support a physiologic link between breast implants and breast implant illness syndrome.
  • Patients, however, sometimes associate feeling unwell with their breast implants and would like to have them removed. With appropriate counselling on potential symptom improvement versus aesthetic consequences, it is appropriate to remove breast implants and as much associated implant capsule as safety allows.
  • Some patients do indeed feel better, but some do not.

BIA-ALCL

  • BIA-ALCL is a rare lymphoma (not breast cancer) associated with the capsule and fluid around predominantly textured breast implants. Thus far, there have been no confirmed cases of BIA-ALCL in women who have had only “smooth-surface” breast implants.
  • Symptoms may include new breast enlargement with asymmetry and pain, lump in the breast or armpit, overlying skin rash, hardening of the breast, or a large fluid collection typically developing at least more than one year after receiving an implant, and on average after 8 to 10 years.
  • Women who develop BIA-ALCL can often be cured by simply removing the implant and the scar tissue surrounding it. Some patients may require additional treatment. For additional information about BIA-ALCL consult this American Society of Plastic Surgeons BIA-ALCL Summary link as well as Frequently Asked Questions.

FDA Voluntary Recall Of Allergan Textured Breast Implants And Expanders

  • The FDA recommended that Allergan brand textured implants and expanders be voluntarily removed from the market and Allergan has complied. Allergan remains an excellent breast device maker and has a full line of smooth breast devices which continue to be used by a majority of surgeons world wide.
  • This recall is for devices that have not already been placed, not for devices that are currently in patients’ breasts. The FDA, the American Society of Plastic Surgeons, and Allergan (the manufacturer) all recommend not removing textured implants unless there is evidence of a problem.
  • Rather, it is recommended that every woman conduct regular self-examination and be aware of common symptoms as above. Any patient experiencing these or any symptoms should see their doctor for evaluation.

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