Dive Brief:
- The US Food and Drug Administration he responded to expert recommendations for managing cancer risks in people with breast implants.
- A panel of experts convened by the American Association of Plastic Surgeons (AAPS) said A statement released on Tuesday said it may be “reasonable” to remove textured breast implants to reduce the risk of a rare cancer, while noting that the question of whether removal is “recommended” is at the discretion of the surgeon and his patient. .
- The FDA responded Wednesday, stating that “prophylactic removal of textured implants is not recommended in asymptomatic patients” because the cancer they are associated with is “uncommon.”
Dive Insight:
The FDA has ordered an immediate recall of Allergan Biocell’s breast implants and tissue expanders in 2019 in response to cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Biocell devices are macrotextured implants, a design that studies have linked to a higher risk of BIA-ALCL than textured and smooth surface devices.
A panel of experts convened by the AAPS reviewed the evidence for each type of implant to produce a consensus statement on BIA-ALCL published in the journal Plastic and Reconstructive Surgery this week, which included 12 recommendations.
The experts said prophylactic removal of long-textured breast implants “may be considered reasonable” because of the potential to reduce risk. Removal of any type of textured implant can also be considered reasonable, according to the statement, if “a risk stratification and surveillance plan” is performed after implantation.
The final decision about whether to remove an implant “should be shared between the patient and the surgeon after an assessment of the patient’s goals against the perceived benefits of surgery and an individual assessment of surgical risk,” according to the statement. .
In response, the FDA, which has consistently recommended against Prophylactic implant removal has led to the hypothesis that BIA-ALCL is too rare to support the implantation of textured devices in asymptomatic individuals.
“Individual patients should discuss the potential benefits and risks of removal with their healthcare providers to make an informed decision about their health,” the FDA wrote. “Prophylactic surgery presents a range of risks depending on individual patient risk factors, including history and anatomy.”
The removal recommendation is the only conclusion that the FDA reviewed in detail. The other recommendations include a call to stop macrotextured implants and requiring manufacturers to share their internal surveillance data for analysis. Experts see no need to change the use of smooth surface implants.
Correction: An earlier version of this article attributed the statement to the American Association of Plastic Surgeons. The group was also incorrectly referred to as AAPS.
