By Allergan, a leading pharmaceutical company, has just issued a voluntary global recall of its textured breast implants, now linked to a rare form of cancer. The FDA doesn’t recommend patients having the implants removed unless symptoms emerge.
Learn more about why Allergan decided to issue the recall and what this means for patients with textured breast implants.
Textured Breast Implants Linked to Rare Type of Cancer
Allergan will no longer sell or distribute Biocell saline-filled and silicone-filled textured breast implants and tissue expanders after the FDA revealed an increase in BIA-ALCL cases among women with its textured implants. According to the FDA, there have been 573 cases of BIA-ALCL and 33 patient deaths worldwide. 481 of these cases have been attributed to the Allergan implants, and that among the deaths “12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis.”
The FDA also reports that the risk of BIA-ALCL is six times higher with Allergan Biocell textured implants than textured implants made by other manufacturers marketing inside the U.S.
Earlier this year, the agency said there was a lack of scientific certainty about the health risks that these breast implants pose to patients. Yet, there have been 116 new cases and 24 patient deaths since February, forcing the agency to change its findings. With a dramatic rise in BIA-ALCL cases, Allergan has voluntarily recalled the textured breast implants to protect the public.
As of now, it’s not clear whether the texture of the implants is causing the cancer. Some in the medical community say that the textured surface of the implants can interact with the surrounding scar tissue that the body forms as an immune response to the implant, which is believed to cause the formation of lymphoma. For this reason, some plastic surgeons will only use round, smooth breast implants.
The company said Wednesday that healthcare providers should no longer use Biocell implants and tissue expanders, and that all unused products should be sent back to the company. It also said it would work with customers on how to return unused products.
What Is BIA-ALCL and How Common Is It?
BIA-ALCL stands for breast implant-associated anaplastic large cell lymphoma, which is associated with textured-style breast implants. BIA-ALCL is a rare and highly treatable form of anaplastic large cell lymphoma. The lifetime risk for women with textured-style implants is 1:3,000 to 1:30,000.
According to the National Society of Plastic Surgeons, just under 314,000 people received breast implants in the U.S. in 2018, but textured breast implants remain much less common here in the U.S. than they are in Asia and Europe. Textured implants have been taken off the market in many countries around the world for related health complications.
Should Patients Have Their Allergan Textured Implants Removed?
As news spreads of the global recall, many patients are looking to have their textured-breast implants removed, but the FDA doesn’t recommend that people who already have the textured implants get them removed unless they notice symptoms or encounter health problems.
Symptoms of BIA-ALCL include fluid collection in one or both breasts, breast enlargement, swelling, unusual pain, asymmetry, lumps in the breast or armpit, overlying skin rash and hardening of the breast. If patients with Allergan textured breast implants notice any of these symptoms, they should make an appointment with their plastic surgeon. It’s important to note that BIA-ALCL is highly curable and in some cases, the issue can be resolved by removal of the breast implants alone.
For those with Allergan textured breast implants, the company will cover up to $1,000 of out-of-pocket fees toward diagnostic testing for BIA-ALCL. If the patient is diagnosed with BIA-ALCL, they will be eligible for up to $7,500 of out-of-pocket surgical financial assistance toward the removal of the breast implant(s) and the associated scar tissue: a complete capsulectomy. Allergan will also provide replacement implant(s) at no charge. This coverage is valid for cases diagnosed on or after January 1, 2018. For more warranty information, patients should contact Allergan directly at 1-800-678-1605.
As alarming as this global recall can be, patients shouldn’t have their implants removed unless they experience symptoms or health problems. If a patient experiences a medical emergency, they should call 911 or their healthcare provider immediately.
