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. The life of breast implants varies by person and can’t be predicted. That means everyone with breast implants may face additional surgeries—but no one can tell them when. And while a few patients may keep their original implants for 20 to 30 years, that is not the common experience. 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 greater than ten years come in for an exam. Patients can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

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. The FDA recommends that patients with silicone implants get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.

Breast Implant Illness – the Science

Few medical devices have undergone the investigation that breast implants have. There is overwhelming evidence supporting the safety of breast implants. Authoritative review of the scientific knowledge to date has failed to find any evidence based study to support the existence of any breast implant illness syndrome. That said, patients sometime 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. The estimated lifetime risk for BIA-ALCL is 1:1000 to 1:30,000 women with textured implants. The risk varies with implant maker, geographic area, and patient genetics. 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 (such as radiation or chemotherapy). Following removal, replacement with a smooth surface implant may be an option. 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 has recently 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 of 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.   The FDA communication to patients is presented at this link.

The key messages are:

  • ALCL is extremely rare and usually treatable.
  • There is absolutely no recommendation to have implants removed without evidence of a problem.
  • We at Wigod Plastic Surgery are happy speak with you or see you if our perspective and reassurance would be helpful.

Mark D. Wigod, MD, FACS, providing Cosmetic and Reconstructive Plastic Surgery to Boise, Meridian, Treasure Valley and Southeastern Idaho.