Following an FDA recall earlier this year and a growing body of research linking Allergan breast implants to an increased risk of cancer, many women have decided to file lawsuits (individual and class action) against the manufacturers of these products. In these Allergan breast implant lawsuits it is alleged that the Dublin, Ireland-based manufacturer Allergan, failed in its legal responsibility to disclose its awareness of increased risks with its textured Biocell Natrelle Implants to the medical community and FDA. Additionally, these Breast Implant Cancer Lawsuits, it is alleged that Allergan failed in their responsibility under federal law to report adverse events in a timely manner, which would have resulted in these patients choosing an implant with a lower risk of ALCL.
FDA Biocell Breast Implant Cancer Recall
As early as 2011, the FDA announced a link between textured breast implants/textured breast tissue expanders and a patient’s risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). At the time of this announcement, the FDA noted 60 instances of BIA-ALCL worldwide from 1997 until the time of their statement.
Breast implant associated lymphoma is a rare type of cancer that begins in the lymphocytes, cells of the immune system that fight against infection. 95% of all lymphoma is caused by a random genetic event, with the remaining instances due to inherited genetics, viruses, radiation as well as chronic inflammation. Although the risk of this Non-Hodgkin’s lymphoma is linked to breast implants, BIA-ALCL is not a cancer of the breast tissue.
On May 2nd 2019, the FDA released a statement acknowledging that there was more they could do in order to protect women with breast implants and considered requiring additional labeling regarding ALCL risks on textured implants. However, this May 2019 communication also stated that:
At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.
In July of this year, less than two months following the announcement above, a FDA recall of Allergan Biocell implants (textured implants and tissue expanders) was announced. Additionally, the FDA asked that all plastic surgeons immediately stop implanting these Allergan textured products as well as return all remaining inventory. By September 12th 2019, the FDA had issued a Class I recall of Allergan Textured Breast Implants. FDA Class I recalls are the most serious category of recall because it means that “use of these devices may cause serious injuries or death.”
Allergan breast implants and tissue expanders that were recalled include the following:
- 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
The recall does not affect Allergan’s Natrelle smooth or Microcell breast implants and tissue expanders.
Textured vs. Smooth Breast Implants
When deciding on a breast implant for a cosmetic or reconstructive breast augmentation, the choices involved are more complicated than selecting a size or silicon vs. saline. There are also multiple options when it comes to the structure of the outer shell of a breast implant – smooth vs textured.
Smooth Breast Implants: This type of implant is also frequently called “round implants,” and they have a thinner shell than their textured counterparts. They are softer to the touch and move around during activity with less restriction, similar to natural breasts. To date, there have been no confirmed cases of BIA-ALCL in patients with smooth implants unless the patient had previously used textured tissue expanders.
Textured Breast Implants: This category of breast implant can come in either a round or teardrop shape and has a thicker, rougher shell than a smooth implant, resulting in a firmer feel. Textured implant shells feel like sandpaper, which allows them to attach to breast tissue and prevent any movement/rotation. Preventing rotation is important for patients with teardrop shaped implants as well as in patients with concave/convex breast bones that may allow smooth implants to slide out of their desired placement. Currently, all confirmed incidents of BIA-ALCL have been linked to patients with either textured breast implants or tissue expanders.
Allergan Textured Breast Implants Linked to Increased Cancer Risk
There are three major manufacturers of textured breast implants including: Allergan, Mentor, and Sientra. As of September 2019, information from the FDA and American Society of Plastic Surgeons suggests that at least 573 women have been diagnosed with BIA-ALCL following implantation with textured breast implants and/or tissue expanders. Of these cases, 84% were associated with Allergan textured implants, meaning that Mentor and Sientra textured breast implants combined were responsible for the remaining 16% of Breast Implant Associated – Anaplastic Large Cell Lymphoma cases. A study performed in Canada, showed Allergan textured implants as responsible for an even larger share of BIA-ALCL events at 86%.
Additionally, there have been at least 33 reported deaths associated with textured implant related BIA-ALCL worldwide. Although the manufacturer of the deceased patient’s implants was only identified for 13 of these incidents, the FDA confirmed that Allergan was the manufacturer of the implants in 12 of the 13 deaths, which comes out to over 92%. These numbers highly suggest that Allergan’s products may present a much higher risk of breast implant associated cancer than textured implants/expanders as a category.
Symptoms of Breast Implant Associated Lymphoma
The presentation of breast implant associated cancer can occur anywhere between 2 and 28 years following the surgical placement of textured implants or tissue expanders. Most commonly, patients with BIA-ALCL will experience symptoms including intense swelling and pain surrounding their implant. This swelling is caused by seroma, which is a buildup of fluid that can happen very suddenly. Frequently, this rapid fluid build-up and swelling will occur on one side (although there are also patients that present with BIA-ALCL on both left and right breasts). Swelling may also occur in the armpits or lymph nodes if the cancer has spread beyond the breast implant capsule.
Because lymphoma directly involves the immune system, the following more generalized symptoms may also arise:
- Decreased appetite/weight loss
- Increased fatigue
- Night Sweats
- Persistent red bumps or open sores on the skin that may itch – these are tumors.
If you are experiencing any of the symptoms above and have (or have previously had) textured breast implants, please seek medical attention right away.
Diagnosis and Prognosis for BIA-ALCL
The diagnosis of Breast Implant Associated – Anaplastic Large Cell Lymphoma should be performed by an experienced board-certified hematopathologist using the techniques of histology (studying the microscopic structure of tissues) and immunohistochemistry (a process used to identify certain types of cancer by locating antigens based on visual markers). The prognosis for BIA-ALCL can be very good when detected early and the tissue capsule is removed.
Allergan Breast Implant Cancer Lawyers: Free Case Evaluation
Finding the right breast implant recall attorney can help you protect your rights. Call the Willis Law Firm today to speak with a capable and compassionate legal professional who can help you choose the correct course of action for your specific circumstances. This Allergan Breast Implant Cancer Lawsuit evaluation is completely free of charge, and you will not be responsible for any legal fees unless we win your case. With 37+ years of protecting client rights and Board Certification in Personal Injury Trial Law, David P. Willis can help you fight back.