Not all types of medical products that we use are entirely safe. There have been cases where consumers have died or suffered severe injuries as a result of using specific medical devices. One of the recent cases involves Natrelle Biocell textured breast implant manufactured by the Allergan pharmaceutical company. This has led to the worldwide recall of all Natrelle Biocell textured breast implants in the market. If you happen to have any complaints against any pharmaceutical products, Consumer Alert Now is here to offer support.
Understanding Natrelle Biocell Textured Breast Enhancements
Allergan, which is the company behind Biocell breast implants, is a global company that deals with pharmaceutical products. One of their known products is the Biocell textured breast enhancements. The reason why this kind of breast implants are widely preferred are:
- Minimize implant movement
- Minimize capsular contracture ( scar tissues that form around the implant)
The Biocell textured implants are one of the many Allergan’s products that were recalled. The reasons behind the recall are explained below.
How Breast Implants are Used
Breast implants are used in the augmentation of breasts, in an attempt to increase their breast size. They are also used in breast reconstruction, where they are used to replace the breast tissues that have been removed because of severe breast abnormality or breast cancer. Besides that, they are used to reverse a primary breast surgery that failed to improve as expected.
Tissue expander is an example of another device that is used in breast reconstruction. They are used in treating deformities of the soft tissues, underdeveloped breasts, and mastectomy. They are used temporarily for about six months and are placed under the muscle or skin. The tissue expanders are also part of the recalled Allergan products.
Reasons why the Biocell Textured Breast Augmentations were Recalled
The Food and Drug Administration, commonly known as FDA, is the authority behind the recall of all Biocell textured breast enhancements from the United States market. The reason behind the recall is the increased risks of cancer of the immune system known as the Breast Implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Based on FDA’s understanding, the level of BIA-ALCL risks related to Allergan’s Biocell textured breast augmentations is six times higher than other similar products in the market. Therefore, they concluded that the distribution of this product would increase the risk of the condition, hence the recall.
Depending on the data related to BIA-ALCL, a total of five hundred and seventy-three deaths associated with the disease have been reported worldwide by February 2019. Four hundred eighty-one of these patients were announced to have Allergan’s BIocell breast implants during the diagnosis. Among those cases, a total of 12 deaths were associated with patients with Allergan breast implants while being diagnosed with BIA-ALCL.
People who might be affected by BIA-ALCL include:
- Patients who are undertaking reconstructive surgery using the Natrelle Biocell textured products. The patients’ point of exposure is the device itself
- Surgeons who handle the implant
- Healthcare providers who associate with patients with breast implants
Information about the Recalled Products
The Food and Drug Administration is responsible for recalling different Allergan Biocell Textured products. These products include:
- Natrelle Saline- Filled Textured implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Textured Implants
- Natrelle Silicone -Filled Textured Implants
- Natrelle 133 Tissue Expander with Suture Tabs
- Natrelle 113 Plus Tissue Expander
Other details related to the recall are:
- Recall for devices manufactured between 25th July 2014 to 21st June 2019
- Recall for devices distributed between 14th September to 24th July 219
- The total number of devices recalled in the U.S are 246,381
- The date that Allergan issued a voluntary recall was 24th July 2019.
Recommendations for Patients with Allergan Biocell Breast Implants
There are a couple of recommendations issued by the FDA regarding the Allergan Biocell textured implants. The recommendations are as follows:
- Removal of the breast implants even if there are no symptoms available. The suggestion is meant to protect the patient from the low risks of BIA-ALCL. It is recommended to talk to your healthcare provider if this issue comes into question.
- Patients should know the manifestation of the disease and monitor their breast to check the possibility of such conditions
- Patients who might be experiencing BIA-ALCL symptoms should contact their healthcare providers. The evaluation consists of a physical examination, X-rays, and the evaluation of the tissue or fluid near the implant.
- Depending on the discussion with a healthcare provider, patients who have confirmed their BIA-ALCL must have the implant removed. The removal process is quite complicated compared with the initial implantation process
- Patients should keep details about the implant, which includes the name of the implant, device identifiers, and device manufacturer. This information is available on the device card provided by the doctor or surgeon. To get additional information about the product, you can request it from your doctor or surgeon
- Patients should note that cases of BIA-ALCL show up a couple of years after undertaking the breast implant.
The FDA also has a couple of recommendations for patients who are considering having breast implants. Please note that these considerations are meant for different types of breast implants, including Allergan Natrelle breast implants. The recommendations are as follows:
- Breast implants are not intended to be kept for a lifetime. There are chances of having them removed the more you remain with them
- Patients should not assume that they do not need additional surgery once they have the implantation. There are possibilities of incurring some complications which might require surgery
- The more a patient keeps the implants, the higher are the chances of experiencing some complications, which might turn out to be adverse complications. These complications are usually irreversible and undesirable
- There are common complications that result from breast implants. This includes wrinkling, asymmetry, scarring, incision site, infection, and deflation. If you would like to know about the possible complications that might arise, you should ask your surgeon or check for education materials from the manufacturer
- Breast implants appear in different styles, shapes, and textures. You should ask the expectations, benefits, and risks of using any of the available implants with your surgeon
- There are undesirable cosmetic changes that result from breast implantation. This includes breast tissue loss, dimpling, puckering, and other changes
- Patients are advised to take note of any abnormal changes with their breasts or implants and contact their healthcare providers as soon as possible
- There is a potential risk of developing a cancerous condition known as the implant-associated anaplastic large cell lymphoma (BIA-ALCL), in the scar tissue or breast around the implant
- Some patients who have undertaken the breast implant might experience some symptoms such as joint and muscle pains, brain fog, and chronic fatigue. These manifestations do not match any category as a disease hence should not be worrisome to those who experience them
Suggestions for Healthcare Providers
As suggested above, healthcare and surgeons associated with the Allergan Biocell breast implants can be affected by its defectiveness. Therefore, there are a couple of recommendations that have been issued to them. These recommendations are as follows:
- Healthcare provider should stop from using Allergan Biocell Implants and try to return the existing inventory
- There are no recommendations yet regarding the removal of the implants. This is because of the minor risks that the products have in association with BIA-ALCL
- Healthcare providers should inform their patients about the risks of the disease and recommend what they should look for
- Healthcare providers should provide their patients with necessary labeling for the product, education materials, and discuss the advantages and cons of the implants at hand
- Consider the chances of a BIA-ALCL, whether the patient has changes related to the implant. Patients that are suspected of having the condition should be evaluated by a professional who can identify and treat the condition
- The healthcare providers should also take necessary samples such as the seroma fluid for pathology examinations to check the possibility of BIA-ALCL
- Healthcare providers should report cases of the disease to FDA AND MedWatch
Facts About BIA-ALC
LAs defined above, BIA -ALCL is a type of cancer that develops adjacent to the breast implant. This cancer is a type of a non-Hodgkin’s lymphoma, which is considered as the cancer of the immune system. The disease can spread to the body despite the low risks of developing the condition. However, there are high chances of death if the condition is not treated immediately. This kind of cancer affects women with textured breast implants, and no history of the disease is related to smooth implants.
Symptoms of BIA-ALCL
The most significant symptom of BIA-ALCL is a persistent swelling and a mass or intense pain around the breast implant area. Other symptoms include:
- Collection of fluid around the implants years or months after the implant
- A lump in the breast or armpit
- Skin rash
Diagnosis and Treatment of BIA-ALCL
Anyone who’s experiencing consistent symptoms should schedule a meeting with a doctor. The doctor will perform an ultrasound or MRI test to confirm whether there is fluid or a lump around the implant and your lymph nodes. If there is any fluid found around the area, the doctor should draw it and take it to a pathologist for testing.
If the BIA-ALCL is detected early, it can be treated. The patient will have some additional scan done on her to check whether the disease has spread throughout her body.
The treatment process might involve the removal of the breast implant and any fibrous capsule that has formed around the implant. Patients are recommended to have regular imaging to check whether the condition has resurfaced once the implant has been removed.
Handling Concerns for Patient with Breast Implants
Although there are concerns related to Allergan’s Biocell textured breast augmentations, the FDA is continuing with its review of the matters associated with this brand. The FDA has noticed that breast enhancement with larger textures such as Allergan’s textured breast enhancements only accounts for 5% of the breast augmentations sold in the United States. The figure only represents 5% of the implants that are sold, meaning that there is an additional 5%, which is represented by different manufacturers. This makes it crucial to understand and follow the recommendations that they have provided above concerning breast implants and their usage.
Based on the gap that exists when it comes to BIA-ALCL, the FDA has taken some actions which are ongoing. These actions are as follows:
- Get hold and assess reports related to medical devices
- Exchange details about the medical device with other scientific regulators in the United States and internationally
- Review information about breast implant manufacturer which includes facts related to BIA-ALCL
- Assess information related to medical devices that are in the market.
- Monitor severe events from real-world information about defective medical devices
What to Do after Realizing Problems with Your Breast Implants
After realizing that your Biocell textured breast implant is defective, you need to report to the MedWatch through their reporting form. On the other hand, healthcare providers who learn about the possibility of a problem with the breast implant should use the FDA reporting procedure, which is a customary procedure for every facility.
For any questions regarding the implant, please consider the following:
- Contact Allergan(or the manufacturer of your breast implant) through their official contacts
- Request your surgeon to find details of your surgery from the hospital where it took place and learn about the defective product
- Speak to your doctor and learn about BIA-ALCL
- Contact the DICE (Division of Industry and Consumer Education) if you have additional questions
Mass Tort against Allergan
Consumers have the civil right to file a lawsuit against the company that is responsible for a defective medical device. This can be considered when a single victim’s lawyer finds out that the device in question has affected other people apart from his or her client. The court will offer permission for the mass tort based on the following:
- If the number of plaintiffs involved in the case is many
- If the plaintiffs are located close to each other
- Whether the plaintiffs suffered similar injuries
- If the claims that the plaintiffs are making are related to a common cause such as a single product
Once the court has found the eligibility of a mass tort, it will quickly assign a judge to handle the case. The judge will order a notice to be published so that every person who has suffered harm from the product can join the lawsuit.
A mass tort is usually confused with a class action. It is recommended to learn the difference between the two to determine which suits you best. The main difference between the two legal actions is the fact that a mass tort treats every claimant as an individual. Therefore, the court will try to establish how each person was affected by the defective product and award damages according to the injuries sustained.
However, the case is quite different when it comes to class action. In this type of legal action, the court orders a class representative who will stand for a group of claimants, known as a class. Therefore, the court will end up treating all claimants as an individual and end up awarding damages conclusively.
Mass tort usually has an advantage when compared with a class action since it carries a less number of people, and claimants have the chance of getting substantial compensation.
How to Join a Mass Tort Legal Action
The most critical aspect of joining a mass tort case is to prove the connection between your injuries with a particular medical device. Therefore, the plaintiff should be careful when filing a mass tort since there might be other factors related to the physical injuries that he or she has experienced. However, the case is eligible if the Food and Drug Administration has questioned the medical device in question.
If the plaintiff is entirely convinced about the defective device, he or she should contact a lawyer, who in turn will contact other lawyers attached to a similar case. At this point, the mass tort action will have made its foundation based on the fact that there are other lawyers involved in a similar case.
The mass tort will use experts, witness testimonies, and other professionals to support the lawsuit. It is crucial to establish the relationship between the physical injuries sustained by the plaintiffs and the responsible party to increase the chances of succeeding in the case. The lawyers involved in the case will have to investigate each victim and witness before taking the case to court.
Once the case has been presented in court, the lawyers should prove that the defendant is responsible for the damages. Fortunately, it is easy to present enough evidence since this kind of lawsuit involves a lot of people.
Development in Mass Tort against Allergan’s Natrelle Biocell Textured Breast Enhancements
Allergan announced on 30th July 2019 that it would remedy its textured breast augmentations with free-smooth device replacement and compensate specific fees. However, it did not offer reimbursement to the costs included in medical expenses and implant revision, since medical insurances do not cover such costs.
This prompted a class action against Allergan in different parts of the United States. As of 3rd October 2019, plaintiffs with pending motions before the JPML ( Judicial Panel on Multidistrict Litigation) decided to centralize the lawsuits against Allergan into a Multidistrict Litigation (MDL). This will change the class actions into a mass tort since they will be consolidated into a single trial. In this case, a single judge will be assigned to preside over the lawsuit in one federal district.
The District courts that are preferred for consolidation include the District Court for the Middle District of Tennessee and the Central District of California. Eligible plaintiffs decided on the consolidation based on the following factors:
- Claims that the defective implants involved thousands of other women whom some have not exhibited the symptoms which are common with BIA-ALCL
- Claims that the sharp increase of BIA-ALCL led to the recall of Natrelle Biocell textured breast enhancements in July 2019
- Claims that Allergan Biocell textured breast augmentations have a six-time more probability of causing BIA-ALCL compared with other products in the market
- Claims that the recalled Biocell textured breast enhancements have been in the market for more than a decade, although Allergan has recalled them
- Allergan has not agreed to fully reimburse all the costs involved in the removal and replacement of their breast implants
Although the consolidated lawsuit appears to work as a mass tort, there are a couple of elements that will change. For instance, individuals involved in the claim will retain their separate identities and will receive trial as individuals before the MDL judge, similar to a mass tort case.
Recoverable Damages in Biocell Textured Breast Enhancements Mass Tort
Eligible plaintiffs in a mass tort action against Allergan have the freedom of seeking compensation for different damages. Some of the costs that they can recover include past and future:
- Medical expenses resulting from the physical injuries
- Pain and suffering caused by the injuries
- Wage loss
- Lost earning capacity
- Loss of enjoyment
- Burial and funeral expenses if there is anyone who died as a result of the damages
- Punitive damage, if found necessary
Please note, there is a possible problem when it comes to seeking compensation for a large group of people. Those who come early might get compensation, leaving little or no compensation for current impairments. Also, those with severe impairments might get lesser funds once the company decides to compensate.
Find a Textured Breast Implant Mass Tort Near Me
The fact that you have suffered injuries as a result of the defective Natrelle Biocell Textured breast implant means that you must seek compensation. This cannot be achieved without the involvement of a professional legal expert who is familiar with defective medical device lawsuits. Consumer Alert Now offers the best legal services when it comes to such cases. Contact us today at 800-511-0747 and let us handle your case wherever you are within the United States.