A worldwide recall has been issued by Allergan for its tissue expanders and Biocell textured breast implants. Both of these products have been connected to the development of a rare form of cancer. The recall request was issued to Allergan by the U.S. Food & Drug Administration (FDA). The FDA asked the company to voluntarily initiate the Allergan breast implant recall. A press announcement by Allergan stated how the manufacturer was implementing the recall as a precaution. The company did this after being notified of the high risk of anaplastic large-cell lymphoma linked to their defective breast implants.
Textured Breast Implants
According to the FDA, these incidences of cancer are not as common in the United States as in other countries. The United States recall comes after 38 other countries have already removed the products from their markets. Allergan manufacturers macro-textured breast implants and which are used in less than five percent of all United States breast implant procedures. The Director of the Office of Surgical and Infection Control Devices, Dr. Binita Ashar, estimates that there are hundreds of thousands of women who are currently using these breast implants.
What Is Important To Know
The FDA initially informed Allergan and other manufacturers in the industry in 2011 that there could be a connection between a rare cancer and these specific breast implants. The rare cancer was identified as anaplastic large cell lymphoma, or BIA-ALCL. The FDA isn’t advising women with these breast implants to have them removed. This should only be a consideration if a woman is experiencing BIA-ALCL symptoms. Women with these breast implants who are experiencing symptoms should first speak with their physician before considering removal. Pain in the area of the implant, as well as swelling, are the most significant BIA-ALCL symptoms.
According to the FDA, there have been over 573 cases around the world and more than 33 deaths associated with this breast implant. The risk of BIA-ALCL with Allergan’s textured breast implants has also been found to be 6 times greater than the risk of cancer with other breast implant manufacturers. Dr. Amy Abernethy, the FDA’s Principal Deputy Commissioner of Food and Drugs, stated that the number of BIA-ALCL occurrences are in the low range but have been directly connected to Allergan.
Breast Implant Safety
The need to determine the steps required to maintain proper management of breast implant safety was discussed by the General and Plastic Surgery Devices Panel of the FDA’s Medical Devices Advisory Committee. The administration plans to continue evaluating all the new information available as a way to identify the risks associated with developing BIA-ALCL. They will also advise when it is necessary to take action involving breast implants. These determinations will not be limited to certain implant models and will include both non-textured and textured breast implants. The panel will provide advice based on the latest developments concerning women’s health to all health care professionals. Any new information concerning any medical developments with BIA-ALCL will be provided as well.
Risks of Breast Implants
While the majority of women around the world who have breast implants do not experience any significant complications, the recent recall and risk of cancer is enough to warrant caution. Over 19 percent of women who have breast implants for augmentation purposes will be required to have a procedure to remove them within ten years due to complications that may develop after long-term use. The FDA tells women that breast implants are not intended to be with them for a lifetime. These are devices with a specific lifespan. In most cases, they can last up to ten years. The length of time will be based on the type of breast implant and the patient who has them. There are various sizes and shapes of breast implants available on the market and they all have the possibility of rupturing or leaking.
Physicians should discuss with patients the risks of having breast implants and the possible complications that could occur from the procedure. This could involve discomfort from the implant as well as scarring near the implant area, soreness, and more. Over the last few years, physicians performing implant procedures have become more aware of certain forms of lymphoma associated with having implant procedures. Other potential adverse side effects of breast implants include:
- Additional corrective or removal surgery
- Capsular contracture
- Breast pain
- Changes in sensation of the nipple and breast
- Rupture, deflation, or leakage
- Seroma (fluid accumulation)
- Wrinkled skin over the implant area
The number of individuals getting breast implants has increased around the world. These surgeries can be done for reconstructive purposes as well as cosmetic and aesthetic purposes. The FDA advises women who have breast implants that are the subject of a recall to maintain their normal medical routine and follow up with their physician. Should a woman experience any type of changes in their health, they should immediately contact their physician.
Which Allergan Products Are Being Recalled?
Here is the official FDA list of Allergan breast implants that are being recalled:
- Natrelle Saline breast implant styles 168, 363, 468
- Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle 510 Dual-Gel styles: LX, MX, FX
- Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
- Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
- Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
- Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
- Natrelle 150 Full Height and Short Height double lumen implants
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
- Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
Contact KBA Attorneys to File a Breast Implant Lawsuit
KBA Attorneys are legal professionals who are committed to helping anyone who has been the victim of a faulty breast implant. Our breast implant lawyers have years of experience in handling defective product cases and will help you fight for the compensation that you deserve.
Call 855-281-2571 or fill out an online form for a free consultation.
- Jacqueline Howard. “Worldwide recall issued for textured breast implants tied to rare cancer”, CNN, https://www.cnn.com/2019/07/24/health/breast-implant-recall-allergan-fda-bn/index.html. Accessed July 31, 2019.
- FDA. “Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders”, U.S. Food & Drug Administration, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders. Accessed July 31, 2019.