Are Allergan’s Natrelle BIOCELL textured breast implants and tissue expanders safe?
If you are one of the more than the 10 million women who have received breast implants over the past decade, then we encourage you to read about the U.S. Food and Drug Administration’s voluntary recall of Allergan’s Natrelle BIOCELL Textured Breast Implants and Tissue Expanders.
Silicone breast implants, a medical product that suffered a major safety warning and ban in the U.S., made a surprising comeback when the U.S. Food and Drug Administration (FDA) reversed its decision in 2006 to ban silicone breast implants and restored the medical device to the marketplace. This was after intense pressure from manufacturers even though safer, smooth, saline-filled implants posed less of a threat to women’s health.
Lobbying by leading manufacturers, Allergan and Mentor, led to the decision by regulators who chose to ignore frequent ruptures and leaks and other ailments reported by silicone and textured breast implant patients. Women were misled and told these concerns were in the past. A recent worldwide investigation by the International Consortium of Investigative Journalists (ICIJ), however, has helped us see the truth.
It is known that breast implants are linked to autoimmune disorders and now it is been discovered that Allergan’s Natrelle BIOCELL Textured Implants are linked to a rare form of cancer that is claiming women’s lives called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The ICIJ found that the FDA allowed breast implant manufacturers to withhold evidence and to shield the extent of harm these medical devices cause. The FDA allowed these manufacturers to report injury, such as rupture, as routine events, or to report on spreadsheets, thereby not requiring them to disclose these critical events to the public.
The ICIJ analyzed the FDA’s adverse event data from 2016 to 2018. In 2016, before the FDA tightened its enforcement of reporting rules, there were fewer than an average of 200 adverse events reported. In 2017, that number rose to 4, 567 and the number increased to at least 8, 242 in the first half of 2018. How can we account for this increase? Experts report that it is not that implants have suddenly become unsafe but that they were never safe to begin with.
What you need to know.
The FDA issued a voluntary global recall of Natrelle BIOCELL Textured Breast Implants and Tissue Expanders on July 24, 2019 to protect individuals from the increased risk of a rare type of cancer: breast implant-associated anaplastic large cell lymphoma, associated with Allergan BIOCELL textured breast implants.
The FDA decided against taking action on these implants as recently as two months before the recall. In March of 2019, regulators spent two days hearing testimony from women who had developed lymphoma or other symptoms following breast implant surgery. The agency decided in May of 2019 that there wasn’t enough evidence to warrant a recall. Only when a new batch of data surfaced in July of 2019, showing a significant increase in both the number of cancer cases and deaths, did the FDA take the unusual step of asking Allergan to issue a recall.
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly-submitted Medical Device Reports (MDRs) showing worldwide cases of breast implant-associated anaplastic large cell lymphoma related deaths linked to these devices. Allergan agreed and is voluntarily removing these products from the global market.
The FDA’s analysis was attributed to a reported new worldwide total of 573 breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 were reported to have Allergan breast implants at the time of diagnosis.
Based on information currently available—including newly-submitted data—analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers who market in the U.S.
Although most cases of BIA-ALCL are associated with the use of textured breast implants—particularly macro-textured implants such as those made by Allergan—a continuing assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants is now underway.
What is BIA-ALCL?
BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system) and is not breast cancer. BIA-ALCL is often found in scar tissue and fluid near the implant, but in some cases, it can spread throughout the body.
In January 2011, the FDA first reported a possible link between both saline and silicone breast implants and ALCL in the tissue near an implant.
The overall incidence of developing BIA-ALCL is considered to be low at this time; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early and treated promptly. In most patients, BIA-ALCL can be treated with surgery to remove the implant and the scar tissue surrounding the implant. Some patients may require treatment with chemotherapy and/or radiation therapy.
As of July 6, 2019, the 573 MDRs—of BIA-ALCL in the US and worldwide— shows a median age of 53 years old for diagnosis of ALCL for women who sought either breast augmentation or breast reconstruction after breast cancer and were exposed to these products. Allergan products accounted for a larger number of cases than any other manufacturer.
Many women who have a mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are two ways to reconstruct a breast. Your surgeon can use tissue transplanted from another part of your body such as your back, belly, or thighs or by inserting an implant that’s filled with saline (salt water) or silicone gel. For breast augmentation, the same options are available.
A saline implant has a silicone shell that’s filled with saline. Silicone gel implants are filled with firm silicone gel. They feel softer than saline implants and some women report the texture is more like natural breast tissue.
Once a breast implant is in place, scar tissue forms around it, creating what’s called a tissue capsule. ALCL can develop in and around the tissue capsule.
What are the symptoms of BIA-ALCL?
BIA-ALCL symptoms include breast enlargement or hardening, persistent pain, lump in the breast or armpit, or a large fluid collection surrounding an implant. These symptoms have been reported between 6 months and 26 years after implant placement, and are typically diagnosed an average of 7 to 9 years after implant placement.
Products subject to recall
These are the specific products subject to recall:
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:
• Style 163 BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
• Style 168 BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
• Style 363 BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
• Style 468 BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly named Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:
• Style 110 BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
• Style 115 BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
• Style 120 BIOCELL Textured Round High Projection Gel Filled Breast Implants
• Style TRL Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
• Style TRLP Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
• Style TRM Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
• Style TRF Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
• Style TRX Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
• Style TCL Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
• Style TCLP Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
• Style TCM Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
• Style TCF Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
• Style TCX Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
• Style TSL Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
• Style TSLP Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
• Style TSM Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
• Style TSF Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
• Style TSX Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. The following are the textured styles:
• Style 410FM
• Style 410FF
• Style 410MM
• Style 410 MF
• Style 410 FL
• Style 410 ML
• Style 410 LL
• Style 410 LM
• Style 410 LF
• Style 410 FX
• Style 410 MX
• Style 410 LX
Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:
• Natrelle 133 Plus Tissue Expander (K143354)
• Natrelle 133 Tissue Expander with Suture Tabs (K102806)
What to do.
It is important that women ask their surgeons about these products if they suspect that they have been used in either their breast augmentation or breast reconstruction due to the increased risk of adverse effects and BIA-ALCL.
Textured breast implants—like those in the recall—account for just five percent of all implants sold in the United States, according to the FDA, however, if you or someone you love has been impacted by these findings, please contact us as soon as possible.
On July 30, 2019, Allergan announced it would cover the costs of new implants for people with BIOCELL implants who want to replace them. Allergan won’t pay for surgery costs. The program runs until July 24, 2021.
The attorneys at Cowper Law LLP are former defense attorneys with a deep knowledge of medical devices, FDA law, and products liability. The firm also has a passion for issues facing women (and we currently represent 500+ women in the Essure permanent sterility device litigation where we are one of five law firms sitting on the Plaintiffs’ Steering Committee).
Call us at 877.529.3707 for a free evaluation of your case today.
• FDA Press Release
• Recall: Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders