Litigation is proceeding in New Jersey federal court concerning Allergan’s Biocell Textured Breast Implants. The multidistrict litigation (MDL 2921) was formed in December before The Honorable Judge Brian R. Martinotti and Judge Joseph Dickson.
Back in 2017 and earlier in 2011, the FDA warned about a rare form of cancer – anaplastic large-cell lymphoma, a cancer in the lymphatic system. This rare form of Non-Hodgkin’s lymphoma can develop after a breast implant procedure, specifically textured breast implants, according to the FDA.
Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) may be the result of the texture on the implant, created to keep it in place. The increased surface caused by the texturing may retain more bacteria than a smooth implant. One theory is that biofilms form creating chronic inflammation.
So far, 393 defective product complaints have been filed with 375 actions still pending. In August, a federal judge decided plaintiffs can not withhold their names from Allergen. Plaintiffs filed pleadings asking to use a pseudonym or initials to avoid disclosing personal medical information.
The MDL is addressing some common facts – when did Allergan know or should have known about the risks of textured breast implants and their connection to a rare form of cancer and whether the company provided adequate warnings, testing and manufacturing of the implants.
While the Allergan products were supposed to have been removed from the market last year, not all of the implants have been accounted for.
Because of that, the FDA on September 12, 2019 – FDA announces Class I global recall of Allergan Natrelle BIOCELL textured products, saline and silicone breast implants plus tissue expander. Class 1 is the most serious recall.
At that time, the agency found there were 573 BIA-ALCL cases involving 481 Allergan breast implants. This includes 33 deaths, frightening news for the more than 300,000 woman who have breast augmentation annually in the U.S.
The reason for the additional is incomplete device tracking data on about 52,000 BIOCELL breast implants. Patients were told to reach out to Allergan to determine if the company has their implant information or to contact the surgeon or hospital to retrieve their medical records.
Allergan also makes Biocell textured implants for other names including Natrelle, Inamed, and McGhan.
Initially, in July 2019, Allergan announced a worldwide voluntary recall of BIOCALL textured breast implants and tissue expanders, both saline and silicone filled. Allergan also makes Natrelle smooth and Microcell breast implants and tissue expanders which are not named in the recalls.
AbbVie (ABBV) a global pharmaceutical company based in Chicago, purchased Irish-based Allergan plc in May 2020 for $63 billion. Allergan is best known for its Botox and Juvéderm brands in the aesthetics division. This was one of the biggest deals in pharmaceutical industry.
Not Breast Cancer
In a new analysis, the FDA calls its findings a spike in cases. Among the 160 cases seen from July 2019 through January 5, 2020, the total of unique cases of BIA-ALCL came to 733. Three deaths were included. Of those cases reported to the FDA, 85 percent were Allergan implants.
A 2016 paper published in Aesthetic Surgery Journal found chronic inflammation from scar tissue may be the body’s way of responding to a foreign body, triggering an immune response and cancer. The lymphoma is always found in the scar tissue capsule.
Not only are the breast implants the subject of a recall but so are the tissue expanders, used in breast reconstruction following a mastectomy. An expander is intended to be a temporary implant.
The problem- a risk of anaplastic large cell lymphoma (BIA-ALCL), which is a cancer of the immune system. The FDA finds that the Allergen textured breast implant represents six times the risk of BIA-ALCL. The real-life consequences find that among 573 cases, 481 of those patients had the textured implants at the time of diagnosis. Among the 573, there were 13 deaths.
The BIA-ALCL is usually successfully treated by removing the scar tissue and the implant. Additional radiation and chemotherapy may not be needed.
Why use a textured breasts implant?
Some surgeons have chosen a textured implant because they are reported to hold their position better and may be ideal for patients who have had mastectomy. Included in the recall is the Allergan Natrelle 133 and 133 Plus tissue expanders. To date they have not been associated with the cancer even though they have the same proprietary texture.
This recall is for the unused stock of BIOCELL implants and tissue expanders from doctor’s offices and hospitals. Patients with the troubling implants were told they did not need to have them removed.
Patients worried do not have to have the implants removed. Allergan had sent an urgent warning to U.S. customers, primarily surgeons, instructing them to return all unused implants.
As of early 2020, cases of ALCL associated with textured implants are blamed on 36 deaths and 733 cases of ALCL.
The cancer is identified in the scar tissue and fluid surrounding the implant. BIA-ALCL can spread throughout the body. Symptoms of this type of cancer are pain or swelling near the breast implant. Other symptoms of this type of cancer are:
- Lumps in the breast or armpit
- Breast hardening
- Changes in the appearance of the breast
- Redness or rashes
- Weight loss
The BIOCELL textured implants represent less than 5% of the market of all breast implants in the U.S. and 10% of ALL breast implants sold in the U.S. Look at the FDA to determine if your particular textured breast implant is included.
October 2020 Medpage today
In June of 2020, Allergan launched a multi-pronged campaign to contact patients who may not be aware of the year-long campaign.