A request from the U.S. Food and Drug Administration (FDA) has led to an Allergan implant recall, due to an increased risk of cancer.
Research links these breast implants with a significantly elevated risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is a type of non-Hodgkin’s lymphoma wherein cancerous cells develop in the fluid and scar tissue that forms around the implant. The only treatment involves major surgery to remove the implants, followed by reimplantation or breast reconstruction.
If you suspect a breast implant recall might affect you or a loved one, you could be entitled to financial compensation. The experienced personal injury lawyers of Gerling Law can help. We fight to get you the maximum possible compensation. Contact us today to learn more about pursuing a breast implant cancer claim.
Allergan Breast Implant-Related Cancer Risks
With headquarters in Dublin, Ireland, Allergan Inc. manufactures pharmaceuticals, aesthetic products, and medical devices, including breast implants. The company’s BIOCELL® line, the subject of the current recall, features a textured outer shell. Allergan promoted the textured shell design as a better way to keep implants in place and minimize rigid scar tissue development around the implant.
Although medical researchers do not yet have a full understanding of this cancer, some data suggest that it starts with a bacterial infection. This infection may develop due to an increased ability of the textured shell to harbor bacteria. The greater the surface roughness of the implant shell, the higher the risk. In fact, Europe has banned the use of highly textured (or “macro-textured”) implants, such as the Allergan BIOCELL, for this reason.
If you have macro-textured Allergan implants, you face a sixfold increase in your risk of developing breast implant-associated lymphoma. According to data from the FDA, almost 600 patients have developed breast implant cancer to date. More than 90% of those who died of BIA-ALCL had Allergan implants. More recent data from the American Society of Plastic Surgeons put the number of victims at almost 750. Some reports estimate the risk of developing BIA-ALCL at 1 in 1,000 if you have textured implants.
Facts Regarding the FDA Allergan Breast Implant Recall
In July of 2019, the FDA requested that Allergan recall the implants in question. Shortly thereafter, Allergan announced a recall of its BIOCELL® textured implants and tissue expanders. The company had recalled these products already (by April of 2019) in the United Kingdom, Canada, and Europe.
Evidence indicates that Allergan potentially had knowledge of these cancer-related risks, possibly as early as the 1990s. In Allergan’s 2018 SEC filing, the company referenced the existence of multiple lawsuits on this matter, including a potential Canadian class-action suit. The report referred to breast implant litigation cases as a threat that could adversely affect the business.
Despite knowing that their BIOCELL products could be killing people, Allergan failed to pull them from the market until the FDA’s request.
Symptoms of Allergan Implant Cancer
Because BIA-CLCL is a relatively new disease, the medical community does not yet have a full understanding of its scope. Currently, the FDA is actively researching breast implant lymphoma to expand their understanding. What they do know is that, in BIA-CLCL, cancer cells develop in the fibrous capsule of scar tissue around the implant. Cancer cells can also develop in the fluid that accumulates between the implant and the scar capsule.
If you develop this rare form of t-cell lymphoma, you might not experience the onset of symptoms for a decade after implantation. Some of the most commonly known symptoms of BIA-ALCL include the following.
- Breast swelling,
- Skin irritation,
- Breast lumps, and
- Breast pain.
BreastCancer.org reports that some victims experience a series of less direct symptoms. These symptoms include chronic fatigue, joint and muscle aches, rashes, problems with memory and concentration, problems sleeping, gastrointestinal issues, and even mental or emotional challenges including depression and anxiety.
The FDA reports that symptoms are typically persistent. Unfortunately, the potential for misdiagnosis is high, simply because this disease remains relatively obscure.
How Is BIA-ALCL Treated?
The FDA recommends radical surgery for anyone who has a confirmed BIA-ALCL diagnosis. This surgery is more extensive than simply removing the implant. The surgeon must remove the implant and the surrounding scar tissue capsule. Some experts recommend removing the entire structure (implant and capsule) in one piece, to minimize future risks.
If the victim has symptoms, experts do not recommend getting new implants. This leaves victims in a difficult—and potentially traumatizing—position. In some cases, surgeons can convince the victim’s health insurer that implant removal is medically necessary. Rarely, however, will your health insurance agree to cover reconstruction.
Reconstruction can involve getting new implants or an autologous procedure. In an autologous procedure, the surgeon harvests fat or flaps of tissue from elsewhere in the patient’s body and uses them to reconstruct the breast. Some victims choose to “go flat,” which means not having any future breast reconstruction. However, even going flat requires extensive cosmetic surgery. The final option, arguably the least desirable for most victims, is to leave the area as-is. This generally involves stretched, excess skin and sunken areas where the implants once were.
Once the implant and scar capsule is removed, the prognosis may be optimistic. However, until researchers learn more about this disease, no one really knows how it may affect victims in the future.
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Can You Sue for Allergan Implant Complications?
If you or a loved one suspect an implant-related health problem, contact a defective medical device lawyer as soon as possible. You may have a valid basis for pursuing a legal claim or filing a lawsuit.
Other implant recall victims have filed lawsuits against the manufacturer. Many of these suits allege that Allergen knew about the risks posed by BIOCELL implants, yet they continued to supply them to the marketplace. Further, Allergan failed to warn surgeons and consumers regarding these significant risks. As a result, victims developed serious or life-threatening cancer.
Understandably, you might be too concerned about your health and well-being to consider legal action. However, pursuing a legal claim can provide substantial benefits and peace of mind. If you do require major surgery (or surgeries), and extensive medical treatment, you need a way to pay for these services. If ill, or undergoing removal or reconstructive surgeries, you are also likely to miss a significant amount of work. A settlement or award can help you cover your expenses and pay your bills until you can return to work.
How Can an Allergan Implant Recall Attorney Help?
For more than 50 years, the experienced attorneys of Gerling Law have fought passionately to assist wrongfully injured clients.
Having an experienced tri-state product liability attorney on your side helps protect your legal rights and ensures you get justice for the harm you have suffered. As you can see by our long history of settlements, verdicts, and awards, we work tirelessly to get the results our clients deserve. To date, we have recovered more than $500 million for the wrongfully injured.
We will put the full force of our resources to work to get you the maximum possible compensation.
If you lost a loved one as a result of breast implant cancer, contact one of our wrongful death attorneys to discuss the possibility of pursuing a claim.
No settlement or jury award will bring back your loved one. However, getting justice for your lost loved one can help bring closure to you and your family. A wrongful death settlement can also provide financial security, especially if you relied on the victim’s income and household assistance. You may be eligible to recover damages for funeral and interment costs, loss of financial support, loss of love and companionship, loss of future income and inheritance, and emotional trauma.
Contact a Breast Implant Recall Attorney at Gerling Law Today
You don’t have to fight this battle alone. We will fight fiercely for you and your right to justice for any damages you have suffered. Proving harm due to defective medical devices (such as breast implants) can be highly complex. Fortunately, we have extensive experience helping clients in mass torts for dangerous drugs and defective medical devices.
We provide a no-cost case analysis to help you explore your options and get started with the legal process. And we collect no legal fees until your case is resolved and we recover compensation on your behalf. Call us now at (866) 751-5172 or contact us online to speak to one of our Allergan breast implant recall attorneys.
