According to a medical news report posted on medpagetoday.com, recent studies show that the number of actual breast implant-related Lymphoma cases could be at least twice as high as the Food and Drug Administration’s estimates. The number of breast implant anaplastic large-cell lymphoma (ALCL) cases occurred at a rate of 8.1 per 100 million people annually. However, the rate in recent years has surged to 14.5/100 million in the past several years. In 2007, the FDA estimated that the rate was as low as 3/100 million.
This substantial increase in breast ALCL in the United States is similar to the number of breast ALCL being reported in Australia, the Netherlands, and New Zealand. It is believed that the rising cases of breast ALCL coincide with the increasing use of textured breast implants. Textured breast implants have been connected to breast ALCL. The news article states that previous breast ALCL studies “underestimated the risk of developing this rare cancer following breast implantation.” Countries such as Australia have already banned some types of textured implants. However, in the United States, certain implants are required to have a black box warning label. Other countries have not taken any action.
In 2018, one year prior to the FDA and regulatory agencies issuing a recall of Allergan textured breast implants, the implants were found to be closely tied with breast ALCL. The FDA has not recommended removing textured breast implants if there are no symptoms. However, women who have textured breast implants should be advised that there is an increased risk of developing ALCL. Although many factors may cause the increased occurrence of breast ALCL, researchers hypothesize that the increased use of textured breast implants could be responsible for the rise in ALCL cases. Safety advocates want the revised risk estimates to be shared with all patients considering breast augmentation, especially if textured breast implants will be used in their procedure.
More than ten years ago, the U.S. FDA published its first safety communication concerning silicone gel-filled breast implants. One year prior to the Allergan recall, the FDA reported that there was a growing number of implant-associated ALCL cases and then asked Allergan to recall its textured breast implant products. Other manufacturers of textured breast implants were not asked to issue a recall of their products. The FDA then called for a boxed warning to be placed on all breast implants sold in the United States. The recall and black box warning did not recommend the removal of breast implants unless there were signs and symptoms. One study of ALCL estimates that about 3 million women in the United States were implanted with textured breast implants by 2015.
Unfortunately, there has been no specific guidance concerning ongoing follow-ups and cancer screenings for patients who have textured breast implants. The FDA does not advise women to remove their implants unless negative health signs or symptoms exist. The average time from implantation to ALCL diagnosis is 7 to 8 years.
Safety experts believe that many clinicians and plastic surgeons are unaware of the risks. About 90% of breast implants used in Europe are textured breast implants. These types of implants are not as popular in the United States.
According to David Horowitz, MD, of Columbia University, the number of breast ALCL cases is noteworthy.
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