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24 July 2019

This morning, the US FDA announced that it was recommending that specific models of breast implants manufactured by Allergan be removed from the market due to concerns about breast implant associated anaplastic large cell lymphoma (BIA-ALCL), a form of cancer. Allergan responded by announcing a worldwide recall of BIOCELL textured breast implants.

The FDA announcement notes that 573 cases of BIA-ALCL have been diagnosed worldwide, and the majority of the cases (481) have been linked to Allergan implants. While BIA-ALCL is thought to be curable by removing the implant and capsule, the FDA announcement reports that 33 patients have died. In 13 of the cases (of patient death) where the implant manufacturer was known, 12 patients had Allergan implants. The FDA announcement was prompted by information received since March 2019, when the FDA issued a letter to healthcare providers and held a public meeting to increase awareness of BIA-ALCL and to request that suspected cases be reported.

The plastic surgeon’s office typically keeps a record of the type of implant placed. Today’s FDA announcement stated that the majority of implants placed in the US are NOT the textured form, and that the specific type of Allergan implant implicated accounts for about 5% of all implants placed in the US. BIA-ALCL is not common, and typically presents with rapid accumulation of fluid (that a patient would notice as swelling) sometime after placement. As always, report any changes to your physician.

Update after 7/25/19 FDA call: I had the opportunity to sit in on a call with the FDA and several other surgical societies this morning and a few points were made:

  • The implants implicated in the recall were not marketed in the US prior to March 2000.
  • A small percentage of cases of BIA-ALCL have occurred in patients who have no history of textured implants.
  • Tissue expanders, the temporary “spacers” that are often used prior to stretch the skin and muscle, are often textured. They are not usually left in place for more than a few months, but the FDA did not have any information or insights as to whether these might be the cause of BIA-ALCL in patients with no history of textured implants.
  • The FDA is not recommending removal of implants in asymptomatic patients. They stressed that if implants are removed, the implant capsule (the fibrous scar tissue that normally forms after implant placement) also needs to be removed, because that is where the ALCL develops.
  • It was discussed that there is no “early detection” for BIA-ALCL, and that patients may not be comfortable with a “watch and wait” approach.
  • Concerns were raised about insurance coverage for implant removal and replacement, especially in patients who are asymptomatic. The FDA commented that insurance coverage issues are out of their scope of practice but they recognize the problem. They did note that they had met with patient advocate groups earlier today
  • All of the representatives from the surgical organizations that were on the call agreed that education of their members as well as the larger physician community is necessary. A representative from the American Society of Plastic Surgeons noted that they have been educating their members for some time and have patient resources on their website. They also stressed that if patients note any changes, they should seek out a board-certified plastic surgeon
  • Symptoms of BIA-ALCL include the sudden development of swelling (due to fluid accumulation) with or without a mass. Any changes should be promptly reported.

6 February 2019

The US FDA just issued a letter to healthcare providers, to increase awareness of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

BIA-ALCL is a rare type of T-cell lymphoma, not a type of breast cancer. Approximately 457 cases have been reported and there have been 9 associated deaths. It is estimated that approximately 1.5 million implants are placed per year, worldwide.

Most cases of BIA-ALCL have been in patients with textured implants, although it has been reported in association with smooth implants as well. The current FDA letter notes that many of the reports they have received do not include the surface texture of the implants.

Research has focused on the role of chronic inflammation and perhaps ongoing low-grade infection as potential causes. BIA-ALCL typically presents several years after implant placement, usually as a seroma (fluid) around the implant or as a mass in the implant. Treatment includes removal of the implant and associated capsule (fibrous “shell” that forms around the implant). This is often curative, although some patients may require chemotherapy or radiation. Prognosis appears to be very good. 

In December 2018, Allergan, one of the implant manufacturing companies, suspended European sales of specific types of textured implants to comply with a recall notice for textured implants when their product certification expired. Currently, there is no recall recommendation in the US.

The FDA communication stressed that the number of cases is extremely low relative to how many implants are placed and is not currently recommending that women have their breast implants removed. They are recommending that all cases be reported both to the FDA and to the American Society of Plastic Surgeons PROFILE registry.

On January 28th (before today’s letter to providers was released) FDA Commissioner Dr. Scott Gottlieb announced that an FDA public meeting will be held in late March to discuss concerns related to breast implants. A recent study has noted possible associations with autoimmune disease, BIA-ALCL as well as general safety issues – these will likely all be discussed. Dr. Gottlieb has noted that additional information including a link for public comments will be posted 15 days ahead of the March 25-26 2019 meeting.

 

Additional Information:
Insider: FDA Warns About Cancer Linked to Breast Implants
AP: FDA Alerts Doctors of Rare Cancer with Breast Implants