The US Food and Drug Administration (FDA) has strongly warned against several breast implants available in the market and pointed to increasing cases of new types of cancer even on use of approved products. The FDA warning is based on reviews of post-market surveillance and already published case studies.
The associated cancers include squamous cell carcinoma (SCC) and various lymphomas in the scar tissue (capsule) that forms around breast implants. SCC is a type of skin cancer caused by overproduction of squamous cells in the top layer of the skin. The FDA has cautioned that various lymphoma cases reported due to implants are not the same as described in its previous warnings related to breast cancer.
The warning is a big cause of concern for India, which is the fifth largest market in the world in terms of breast augmentation surgeries. The country ranks third in terms of volume of such procedures. As per the latest GlobalData report, breast implants are the largest segment by value, accounting for around 60 per cent of the total market in 2021 in India.
Asked about the FDA warning on cancer risk of breast implants and the rapidly growing implant procedure market in India, a senior official at the Central Drugs Standard Control Organisation, India’s central drug control agency, said, “…the department currently doesn’t have any data regarding the adverse reports and it may act when it is equipped to generate the same”.
However, in its communication note (for the US), the FDA stated, “…after preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of at least 20 cases of SCC and about 30 cases of various lymphomas in the capsule around the breast implant”. Since September 1, the FDA has received 10 medical device reports about SCC and 12 reports about various lymphomas related to breast implants.
Though there are limitations of data based on medical device reports as those do not necessarily represent unique cases, the FDA confirmed that submitted reports are just one source used to monitor the safety. Additionally, mandated post-market studies, published literature, and real-world data from registries and claims databases are also being reviewed to conclude the rising cases.
