Top Three Messages for Breast Implant Recipients
This week the U.S. Food & Drug Administration (FDA) announced that Allergan textured breast implants had been tied to the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer. After analyzing hundreds of adverse event reports of BIA-ALCL, regulators found certain Allergan implants to carry six times higher risk of BIA-ALCL than other textured breast implants. As a result, the FDA asked Allergan to remove all implicated implants and associated surgical instruments from the U.S. market. The manufacturer took things a step further by promptly issuing a global recall of designated implants.
Note: We covered this type of implant in a previous story detailing a secret FDA reporting program that likely delayed this important recall.
For the hundreds of thousands of women who get breast implants yearly, news that a rare cancer may be associated with their implants can be understandably scary. Fortunately, less than 5% of breast implants sold in the United States are textured like the recalled implants, and only specific Allergan implants have been associated with an increased risk of BIA-ALCL. The incidence of BIA-ALCL is still relatively low, even for the recalled implants.
Allergan has instructed all healthcare providers to stop implanting recalled devices immediately and has indicated that customers will receive complete instructions for returning unused implants shortly. At this time, Allergan has not called for implants to be removed from patients who have already received them.
| Source: FDA.gov |
| Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) |
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| Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) |
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| Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants |
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| Allergan Tissue Expanders with BIOCELL Texturing |
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Reports of BIA-ALCL began to surface in the late 1990s, but high-quality studies only became available in recent years, with the FDA reaching a determination of risk associated with Allergan implants just days ago. Even with the increased risk associated with these faulty implants, experts estimate that only three women out of every 100 million will be diagnosed with BIA-ALCL each year. That means as many as 500 American women could learn they have BIA-ALCL this year.
With a cancer this rare, it can be difficult to generalize treatment success and prognosis, but studies indicate that BIA-ALCL is relatively treatable. With complete removal of the faulty implant and attached capsular (cancerous) tissue, only about 4% of patients experience a return of BIA-ALCL within five years of operation.
The FDA encourages women with recalled Allergan breast implants to learn and monitor for the symptoms of BIA-ALCL.
BIA-ALCL Symptoms:
If any symptoms appear, individuals should seek medical attention immediately. For patients who do develop BIA-ALCL (confirmed by a licensed healthcare professional), the FDA recommends they undergo implant and scar capsule removal.
On average, women are diagnosed with BIA-ALCL approximately 9 years after receiving their implants, but time to diagnosis has ranged from 1 to 20 years in studies. This means recipients will need to maintain vigilance for symptoms for the lifetime of their breast implants. You can find more information about the recall and BIA-ALCL here >>
Learn what to do if you're diagnosed with breast cancer.Despite the low incidence of BIA-ALCL with the recalled implants, Allergan may still face lawsuits over this unexpected and serious side effect. In a similar situation, manufacturers currently face numerous valsartan lawsuits from patients claiming they weren't warned of cancer as a possible side effect. The incidence of valsartan-associated cancer is lower than that of BIA-ALCL, so we may begin to see textured breast implant lawsuits filed in the very near future.
