An increasing number of rare cancer cases have prompted a global breast implant recall by pharmaceutical giant Allergan. The action, while labeled “voluntary,” was at the request of the FDA, which published a safety communication on July 24, 2019.
Federal health regulators felt the recall was warranted to protect consumer safety. There is growing evidence that Allergan’s textured implants can cause a type of non-Hodgkin’s lymphoma. The cancer is known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
If you or someone you love has been affected by the Allergan breast implant recall, or have suffered health complications after breast augmentation or reconstruction with a saline or silicone implant– you may be eligible for legal compensation.
Showard Law Firm is currently reviewing product liability claims involving implant-associated lymphoma and breast implant illness.
FDA requests textured breast implant recall
Amy Abernethy, the FDA’s Principal Deputy Commissioner, said, “Although the overall incidence of ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”
It has been close to nine years since the FDA first noted a possible link between breast implants and anaplastic large cell lymphoma. With just 60 cases worldwide in 2011, there was not enough data to justify the recall– until now.
The decision came after reviewing newly submitted Medical Device Reports that monitor the number of BIA-ALCL cases around the world. The most recent data indicates that 573 women have been diagnosed with BIA-ALCL, and 33 patients have died. The vast majority of these women had Allergan textured breast implants.
The reports also indicate that women with Allergan BIOCELL textured implants have a six-fold greater risk of developing BIA-ALCL than those with other brands of implants.
Allergan implant recall after link to rare cancer
Women have known about potential breast implant risks such as rupture, capsular contracture, and infection, but cancer has never been part of this. The implant recall encompasses all of Allergan’s BIOCELL textured devices, both silicone and saline. BIOCELL refers to the company’s proprietary macro-textured surface that enables the implant to sit more securely and deeply in the breast pocket.
Fortunately, textured implants are relatively uncommon in the U.S., accounting for less than 10 percent of all implants used.
Doctors believe that the textured surface triggers an inflammatory response, which may be the origins of the ALCL. Anaplastic large cell lymphoma is a cancer of the immune system that can metastasize if not surgically excised and treated.
The recent breast implant recall is not the first of its kind. In 2016, the FDA announced a Class II device recall for Mentor Memory Gel breast implants, but this was based on labeling errors and did not pose a risk to patient safety.
Which Natrelle BIOCELL implants were recalled?
According to the FDA, Allergan voluntarily recalled 246,381 breast implants in the U.S. that were distributed between September 14, 2014, and July 24, 2019.
The following styles and models were withdrawn from the market:
- Allergan Natrelle Saline-Filled Textured Breast Implants in styles 163, 168, 363, and 468.
- Allergan Natrelle Silicone-Filled Textured Breast Implants in model numbers 110, 115, 120, TRL, TRM, TRLP, TRF, TCM, TRX, TCL, TCLP, TCF, TCX, TSLP, TSM, TSL, TSF, and TSX.
- Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants in model numbers 410FM, 410FF, 410MM, 410 ML, 410 MF, 410 LL, 410 LF, 410 LM, 410 FX, 410 LX, and 410 MX.
The Allergan recall also includes tissue expanders used for the BIOCELL textured implants:
- Natrelle 133 Plus Tissue Expander (K143354)
- Natrelle 133 Tissue Expander with Suture Tabs (K102806)
Recommendations for affected patients
Women who have BIOCELL textured implants, or who are unsure which type they have, but remain asymptomatic, are advised to speak with their health care provider. At this point, the FDA does not recommend that healthy patients have their BIOCELL implants removed– because of the risk of developing BIA-ALCL is minimal.
Possible symptoms of ALCL are pain around the implant, an overlying skin rash, hardening of the breast, or a mass in the implant or armpit. Prompt imaging and physical examination are crucial since the disease can prove fatal if not promptly treated.
Showard Law Firm can protect your rights
Breast implant manufacturers that conceal known side effects or health risks may be held liable for their negligence. Successful litigation can recoup compensation for past and future medical costs, lost income, diminished earning capacity, as well as pain and suffering.
When it comes to taking legal action based on a defective or dangerous product, time is of the essence. The statute of limitations for filing a lawsuit may be as little as one year, depending on your state of residence. Schedule a consultation– free of charge– by calling Showard Law Firm today. The case review is confidential, and there is no obligation to proceed.
- FDA, FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue
- Insider, Two women have filed a class-action lawsuit against a major breast implant maker after hundreds of Americans developed a rare cancer linked to implants https://www.insider.com/allergan-breast-implants-biocell-linked-cancer-2019-8
- FDA, Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer
- org, Breast Implant Illness and BIA-ALCL https://www.breastcancer.org/treatment/surgery/reconstruction/types/implants/special-report
- Healthline, Breast Implants Being Recalled: What to Know and What to Do Next https://www.healthline.com/health-news/what-to-know-about-breast-implant-recall
- WebMD, Textured Breast Implants Recalled for Cancer Risk https://www.webmd.com/women/news/20190724/textured-breast-implants-recalled-for-cancer-risk