One of the largest breast implant manufacturers, Allergan, has issued a global recall of its Biocell product line of textured breast implants at the request of the U.S. Food and Drugs Administration (FDA).
Major repercussions in the overall breast implant market will follow the voluntary recall of Allergan’s Biocell products.
Biocell implants are saline and silicone-filled breast implants that are textured, allowing the implant to attach to the breast tissue and creating a fuller, more natural-looking tear drop shape to the breast.
Textured breast implants are associated with anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer.
Not a breast cancer, BIA-ALCL is a cancer caused due to the scar tissue or fluid surrounding the breasts. The FDA has reported 573 confirmed cases of BIA-ALCL with 33 patient deaths.
Almost 84 per cent of the confirmed cases have been associated with the Allergan implants, with at least 12 confirmed deaths associated with Allergan implants.
The global recall was initiated after health authorities across the world began to ban the textured implants. Countries such as Australia, Canada, and France were the first markets to be affected, closely followed by Europe and ending with the FDA calling for a voluntary recall.
In certain cases, some markets were heavily affected with market value decreasing by half.
The Australian Therapeutic Goods Administration has banned 25 products, including Allergan’s Biocell textured implants and Johnson & Johnson’s Siltex implants, cutting the market value for the country in half.
Conversely, Canada only banned the Biocell product line which affects Allergan’s bottom line, while allowing other textured breast implants to cannibalize Allergan’s market share.
Figure 1 shows breast implant market percentages by country.
The United States attributes 36 per cent of the overall breast implant market, while other countries still have a significant percentage of revenue generated.
With the breast implant market currently growing at a Compound Annual Growth Rate (CAGR) of 3.8 per cent, the market is likely to see adverse effects from this recall and growth may be stunted in the near future.
Figure 2 shows the proposed market value changes for the breast implant market.
Key to determining the extent of the decreased growth will be how many, if any, additional product lines will be banned.
Since the U.S. holds the majority of the breast implant market, but is not entirely reliant on textured implants, the overall market will lose only 5–10 per cent of its share due to the textured implant ban.
Revised Forecast 1 is the current most likely scenario, unless additional textured implants are recalled, in which case, Revised Forecast 3 will become more likely.
Whichever forecast proves accurate, the overall market is going to decrease in the next year, and the ban will have lasting effects on the breast implant market for the future.