The maker of a popular breast implant is pulling its product from the market due to a link between the implants and a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan announced a global recall of its Biocell Natrelle textured breast implants and tissue expanders on July 24 at the request of the U.S. Food and Drug Administration (FDA).
Thousands of women may be at increased risk of developing cancer after being implanted with Allergan’s textured breast implants. Though rare, the FDA said in a press release a total of 573 cases of BIA-ALCL have been reported to the agency — 116 new cases this year alone — and at least 33 people have died as a result of the cancer.
The FDA has been monitoring the risk of BIA-ALCL since 2011 when it first became aware of the potential link. The agency will continue to monitor the situation and said it could take action against other implants if warranted. Although many may not know whether or not their Allergan Biocell Natrelle textured breast implants are one of the styles that were recalled, we have put together a list of model numbers of those that have been linked to lymphoma in patients.
Textured breast implants are not as common in the United States as they are in other countries. They make up about 5% of the breast implant market in the United States. Nonetheless, thousands of women are walking around with textured implants and are at increased risk of the rare form of cancer.
Textured implants manufactured by Allergan were associated with the vast majority of BIA-ALCL cases. It seems the textured surface of the implant puts women at increased risk of cancer as compared to other kinds of implants. This type of surface is unique to Allergan implants. The risk of BIA-ALCL is 6 times that of other implants.
The risk of developing cancer increases the longer a woman has the implants. Most cases of BIA-ALCL are diagnosed years after breast implant placement. The average age of women diagnosed with BIA-ALCL is 53. Although, the FDA has received reports of women as young as 27 diagnosed with BIA-ALCL. The age range of reported cancers, according to FDA data, is 27-90.
The recall also affects textured tissue expanders manufactured by Allergan. These devices are used to stretch the skin and tissue to prepare for a breast implant. They are often used following a mastectomy or during gender reassignment surgery.
If you have textured implants made by Allergan, the FDA is not recommending removing the implants unless you are having symptoms. The primary symptoms of BIA-ALCL are persistent swelling or pain near the breast implant. You should monitor the area around your breast implant for any changes.
If you notice any changes or have concerns, talk to your healthcare provider immediately. Your doctor will perform an evaluation for BIA-ALCL which typically involves a physical exam, imaging, and assessment of the fluid or tissue around the implant.
Women with confirmed cases of BIA-ALCL should have their implants removed, along with the surrounding scar tissue. This is a more extensive surgery than implant removal alone. In many cases, BIA-ALCL remains localized in the scar tissue surrounding the implants, but it can spread to other parts of the body if not caught early and lead to death.
Breast-implant associated anaplastic large cell lymphoma is a type of non-Hodgkin’s lymphoma, a cancer of the immune system. It is not breast cancer. BIA-ALCL is typically found in the scar tissue and fluid near the implant but it can spread throughout the body if not caught early or treated promptly.
BIA-ALCL can be successfully treated with surgery to remove the implant and scar tissue surrounding the implant. In some cases, however, women will need to be treated with chemotherapy or radiation therapy.
The main symptoms of BIA-ALCL are persistent swelling or pain in the area of the breast or implant. These symptoms can develop years after the initial implant surgery. Healthcare providers performing an evaluation usually notice evidence of fluid collection around the breast implant. Some women report a lump under the skin or a thick and noticeable scar capsule around the implant.
Following the global recall of its textured breast implants due to cancer risks, Allergan may be facing lawsuits filed by women affected by the dangerous implants. If you or someone you love had Allergan textured implants and developed breast-implant associated anaplastic large cell lymphoma, you may be entitled to financial compensation.
The experienced breast implant attorneys at Schmidt National Law Group can help you understand your legal options and answer any questions you may have. Call 1-800-631-5656 to speak with a member of our legal team today or use the form on the right-hand side of your screen.
How do I know if mine was recalled?
It states model number on the identification card given after surgery. If the ID card is not available, call your surgeon.
How many of these are out there?
There have been approximately 400,000 implants sold since 2010, but this accounts for 5% of implants over the same time period.
What are the odds of getting ALCL?
ALCL is a very rare form of lymphoma. In fact, there are only 400-500 new ALCL cases reported annually.
What are the symptoms that might require me to see my doctor?
See your doctor or implant surgeon if you notice any swelling, pain, lumps or changes in shape.
If I have the recalled implants, what do I need to do next?
You need to contact your implant surgeon and he will indirectly test for issues that may lead to ALCL. If the tests indicate you are at risk, Allergan will replace and pay for everything.