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Following an Allergan textured breast implant recall issued last year, women nationwide have continued to face growing concerns over their future risk of cancer if they previously underwent breast enhancement or reconstructive surgery.
Allergan removed all breast implants containing its Natrelle and Biocell lines of microtextured surfaces, after the FDA confirmed that the design was linked to nearly all cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare type of cancer that may develop in the tissue surrounding the device.
In the following months, women nationwide have been contacting their plastic surgeons to inquire about removing the breast implants, only to discover that Allergan is not agreeing to cover the cost of replacement surgery, leaving most with the textured implants in their body, where they face a continuing risk that cancer may develop.
According to some local media reports, part of the problem is that many women do not know what type of breast implant was used, so they must find their paperwork or contact their original implanting surgeon to verify which design was used.
In many cases, women received the recalled breast implants after mastectomies they underwent while fighting against breast cancer. They now face concerns that getting breast reconstruction has left them vulnerable to cancer yet again.
Following the recall, the magazine Allure published a guide to the breast implant recalls, which addresses both concerns over the recalls, as well as growing concerns over a battery of health problems some recipients and researchers are beginning to associate with breast implants, known collectively as breast implant illness.
The recall does not address breast implant illness, nor has the FDA confirmed that such a syndrome exists. However, the first studies into it are beginning to get underway. In the meantime, tens of thousands of women have formed Facebook groups and other organizations to seek answers and support each other.
Breast Implant Cancer Concerns
Last year’s recall came after a long history of questions over whether there was a direct link between breast implants and lymphoma that developed in the surrounding tissue.
Although earlier recalls were issued in Canada, France, Australia and other countries, Allergan continued to sell the Biocell breast implants in the United States.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
The FDA is not currently recommending that women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.
The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
The recall increased the number of breast implant cancer lawsuits filed against Allergan by women throughout the United States, including class action lawsuits for medical monitoring.