Last week, pharmaceutical company Allergan recalled it’s BIOCELL textured breast implants and tissue expanders. It created the recall in response to a request from the Food and Drug Administration. The FDA found that women with BIOCELL textured breast implants and tissue expanders are developing a rare form of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) at a rate of six times higher than those with other types of implants.
Key facts surrounding the implant recall include the following:
Before the FDA-requested recall, 38 countries had stopped the sale of BIOCELL implants
BIA-ALCL is rare, and about 84 percent of known cases have been linked to BIOCELL implants
The FDA has linked at least 12 deaths with Allergan textured breast implants
If you are suffering because of Allergan-produced implants, Arnold & Itkin is ready to help you. Call our Allergan BIOCELL textured breast implant injury lawyers today at (888) 493-1629.
What You Should Know About the Allergan Textured Breast Implant Recall
What Does the Recall Do & What Implants Does It Affect?
Allergan textured breast implants account for approximately five percent of implants in the United States. Other implants produced by Allergan, such as Allergan’s NATRELLE smooth implants or MICROCELL breast implants and tissue expanders, are not affected by the recall.
A recall means that Allergan’s BIOCELL implants are to no longer be sold in the United States and that doctors will no longer use them. In addition to its United States recall, the company has also issued an international recall.
I Have Allergan BIOCELL Textured Breast Implants, What Should I Do?
The FDA is currently advising that those who have BIOCELL implants should closely monitor them for signs of BIA-ALCL. The administration only suggests implant removal if patients show symptoms of BIA-ALCL. So, the best thing to do if you are asymptomatic is to watch for signs of BIA-ALCL and immediately visit contact your healthcare provider with any concerns.
What is BIA-ALCL & Why Does It Happen?
Breast implant-associated anaplastic large cell lymphoma is a cancer of a person’s immune cells. Though it occurs in the area of the breasts, it is not a form of breast cancer. BIA-ALCL occurs primarily in the scar tissue and fluids surrounding breast implants.
Symptoms of BIA-ALCL include the following:
- Swelling on or near the breasts
- Soreness in the breast area
- Irritated skin on or near the breasts
Though medical professionals are not certain what causes BIA-ALCL, one theory states that the cancer occurs in reaction to a rough implant’s texture. Rough implants are supposed to interact with body tissue to stay in place. Some medical professionals believe that this tissue-implant interaction causes immune cells to accumulate and become cancerous. Another theory posits that a bacterial biofilm coats the surface of textured implants and triggers BIA-ALCL.
Are Those with Allergan BIOCELL Textured Breast Implants at a Higher Risk of Cancer?
Dr. Jennifer Ashton, the chief medical correspondent for ABC News, says that the risk for those with textured breast implants is one in 3,800 on the high side and one in 30,000 on the low side. Those with Allergan BIOCELL breast implants are at a higher risk to develop cancer. The FDA found that out of 573 global instances of BIA-ALCL, 481 are attributed to Allergan implants. This means that Allergan BIOCELL textured breast implant recipients have a six times greater chance of developing BIA-ALCL when compared with those with other types of implants.
What Type of Implants Do I Have?
If you are not sure which type of breast implants you have, your best option is to contact the medical professional who implanted them. Additionally, those with medical implants receive a card from the manufacturer with information about them. Locating this card will help you determine which breast implants you have.
Allergan Implants Caused Me to Develop BIA-ALCL. What Should I Do?
One of the most frustrating facts about the development of this recall is there were signs of the dangers of Allergan textured breast implants in 2011. In 2017, more concerns about Allergan were raised from investigative reports. However, the FDA did not issue a recall of the implants because it cited the need for more research. Even though 38 countries recalled Allergan BIOCELL textured breast implants, the pharmaceutical company continued to off them in the United States until the FDA finally asked for a recall in July of 2019.
If you’ve suffered because of Allergan textured breast implants, help is available from Arnold & Itkin. Our firm has extensive experience representing clients suffering because of the reckless behavior of some of the world’s largest pharmaceutical companies. In fact, our team obtained a $76.6 million verdict for a client suffering because of a Johnson & Johnson product. Our list of victories for clients doesn’t end here—we’ve won billions of dollars for people who need help after life-changing incidents.
Call us today for a free consultation or fill out our simple online form. We have the experience and resources needed to fight for the answers you deserve. Best of all, if we take your case, you’ll never pay any fee unless we win results for you. A member of our team is standing by to talk to you right now at (888) 493-1629