Textured Breast Implant Illness & Lymphoma – Implants Linked to Cancer
On July 24, 2019, the FDA released a statement requesting the global pharmaceutical company Allergan to recall their textured breast implants after an increased number of cancer reports. Cases have been surfacing in the last six years linking Allergan BIOCELL textured breast implants to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma cancer. If you have certain breast implants manufactured by Allergan, you may be eligible to file an Allergan breast implant lawsuit.
FDA Recalls Textured Breast Implants
In a press release, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. stated, “Although the overall incidence of BIA-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”. The FDA has reviewed reports that found 481 cases on BIA-ALCL. There have been 573 cases of BIA-ALCL worldwide, including 33 deaths. In 13 cases where a patient died and the manufacturer of the breast implant was known, 12 of them involved an Allergan breast implant. The FDA says the risk of getting BIA-ALCL from an Allergan textured implant is roughly 6 times the risk compared to similar products from other manufacturers.
Textured implants represent 10% of all breast implants sold in the United States with Allergan being 5% of the implants used. The FDA has instructed all hospitals and doctors to cease the use of Allergan implants to avoid any future cases from occurring. Allergan has complied with the FDA’s request and stopped sales on the implants that were recalled.
Despite this action, the US has been behind the process of banning these products in comparison to other countries. Allergan stopped sales on two of their textures breast implants in Europe and France with Canada following shortly after that in late 2018. The FDA found a possible link between the lymphoma and breast implants back in 2011 but could not find the cause until now. In March, a two-day meeting was conducted to get the implants banned. Women who have been diagnosed with lymphoma shared their story and requested that the implants be taken off the market. Unfortunately, in May the agency declined to ban the implants, claiming that the lymphoma risk was low and that there was not enough data to justify taking the devices off the market. A large increase in the number of cases occurred caused them to re-evaluate the ban and lead to this current decision.
What are Textured Breast Implants?
Sometimes referred to as “gummy bear” implants, textured breast implants are a type of implant that has a textured outer shell, similar to sandpaper. The teardrop shape matched with the outer shell is meant to help the implant stick to the soft tissue and create a more natural look of the breast. The reason as to why texturing leads to cancer in some patients is unknown. Dr. Clemens, a plastic surgeon at the M.D. Anderson Cancer Center in Houston, who has been studying the lymphoma said, “some people may be genetically predisposed to have an inflammatory reaction to the texturing that can gradually lead to cancer.” Some researchers also suspect that bacteria trapped in crevices in the roughened surface might somehow lead to the lymphoma.
What Types of Allergen Breast Implants are Affected?
The list of implants that have been recalled are:
- Allergan Natrelle Saline-Filled Breast Implants (previously sold as the McGhan RTV Saline-Filled Mammary Implant) in styles 163, 168, 363 and 468.
- Allergan Natrelle Silicone-Filled Textured Breast Implants (previously known as Inamed Silicone-Filled Breast Implants) in styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF, and TSX.
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants in styles 410FM, 410FF, 410MM, 410 MF, 410 ML, 410 LL, 410 LM, 410 LF, 410 FX, 410 MX, and 410 LX.
The tissue expanders that have been recalled are:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
What is BIA-ALCL?
BIA-ALCL is a type of non-Hodgkin’s lymphoma that affects the immune system, not to be confused with breast tissue. Non-Hodgkin’s lymphoma (NHL) is a cancer of the blood and typically treatable if found early enough. It comprises just one percent of NHL cases and just 16 percent of all T-cell lymphomas, according to the Lymphoma Research Foundation (LRF). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body and become fatal. Currently, the FDA states if you are having symptoms such as swelling and fluid accumulation around the implant, please consult your doctor to discuss the removal of the implant. If you are asymptomatic, the FDA recommends you do not remove the implant, as the likelihood of developing BIA-ALCL is low.
Do I have a Breast Implant Lymphoma Lawsuit?
You may have a breast implant cancer lawsuit if you underwent a breast augmentation surgery cosmetically or reconstructively and have been diagnosed with ALCL. ALCL can be diagnosed years later as most cases have been found years after the initial surgery took place. BIA-ALCL lawsuit claims can be for one or more of the following:
- Defective design and/or manufacturing
- Failure to warn
- Punitive damage
- Attorney fees
Compensation for these claims can involve medical expenses, lost wages, and pain and suffering. The attorneys at Hastings Law Firm specialize in medical malpractice cases and are equipped to determine whether you may be able to bring forth a lawsuit and recover compensation. Please contact us right away to determine if you are eligible for compensation.
At this time there are several class action lawsuits involving textured breast implants. The Hastings Law Firm prefers to handle your case individually as the compensation received is typically higher than a class action lawsuit. If you believe you have a gummy bear implant lawsuit please contact our law firm today so we can start the process of researching your case and holding the negligent parties accountable for your compensation.
How is BIA-ALCL Diagnosed?
It can be diagnosed by visiting your local doctor for an exam. If there is cause for concern, doctors may perform a magnetic resonance imaging (MRI) or ultrasound of the implant to assess for fluid buildup or a mass. If there is a buildup of fluid or mass, a biopsy will be conducted to test the fluid for a substance called CD30, which is a protein in cell membranes that shows up abnormally in cases of BIA-ALCL. If that fluid test is positive for CD30, ALCL is present in the body and treatment is necessary.
Does This Mean I Have Breast Cancer?
No, BIA-ALCL is immune-related and does not affect breast tissue. BIA-ALCL is a type of Non-Hodgkin’s lymphoma that affects the body’s lymph nodes which are cells directly involved with the immune system. Lymph nodes are found all throughout the body which causes the lymphoma to have the ability to spread if not caught early enough.
What are the Symptoms of ALCL?
The main symptoms of the lymphoma are usually swelling and fluid accumulation around the implant. Patients should also be on the lookout for pain, rashes, itchiness, firmness, masses or changes in the size and shape of the breast. If those symptoms occur, the fluid should be drained and tested for ALCL. Any abnormal swelling in one particular breast is also a red flag.
Do I Have a Greater Risk of BIA-ALCL With Silicone or Saline Implants?
Currently, there is no evidence that suggests the fill of the implant is a direct cause of the lymphoma. There is not enough data to confer whether one is less dangerous than the other.
Should I Get my Implants Removed?
The FDA states anyone with an Allergan BIOCELL implant should not have it removed unless symptoms are present. If symptoms are present, consult a doctor immediately to find out if you have ALCL. If you are diagnosed with ALCL, you may have a breast implant lymphoma lawsuit. Consult with one of our professionals to see if you have a case.
Do I Need to Pay to Have my Implants Removed?
The American Society of Plastic Surgeons has advocated for insurance companies to cover the cost of breast implant removal and other treatments for patients diagnosed with BIA-ALCL. However, insurance companies are not required to so please consult with your insurance company to verify they will cover the cost of the removal.
What if I Don’t Remove My Implants?
The FDA recommends if you have no symptoms of ALCL to not remove the implants due to the low risk of contracting lymphoma. There is still the possibility of being diagnosed with BIA-ALCL years after the implants have been placed.
How is BIA-ALCL treated?
It can be treated by removing the breast implants and the scar tissue or capsule surrounding it. Some patients may need radiation and/or chemotherapy depending on the advancement of the lymphoma.
Were You Diagnosed with Anaplastic Large Cell Lymphoma (ALCL) After Receiving Breast Implants? Are Your Suffering from Breast Implant Illness?
If you or someone you know has been diagnosed with ALCL or dealing with implant illness and had breast augmentation surgery with an Allergan product, you may have the ability to file a lawsuit and seek compensation for any expenses and losses. While the lawyers at The Hastings Law Firm can recommend to you whether you should file a lawsuit and estimate your potential for success, the decision as to whether to file a lawsuit is yours and yours alone. Time is of the essence in such cases as the statue of limitations is often two years from the date of discover. Making the decision to file your lawsuit sooner rather than later can also potentially lead to a faster recovery. Contact our the medical malpractice specialist at the Hastings Law Firm today at 877-269-4620