Allergan is a well-known Ireland pharmaceutical company with an office in the United States. It acquires, manufactures, develops, and markets medical drugs and devices. The company’s products are mainly used in medical areas like gastroenterology, eye care, central nervous system, and medical aesthetics. Allergan is among the leading producers of tissue enhancers and breast implants used by women for several reasons, including increasing their breasts’ size and shape.
While the primary goal of having a breast implant is to change their lives, many women have experienced severe side effects after undergoing the treatment. It explains why Allergan is facing various lawsuits that have caused it to recall some of its products from the market. If you have incurred an injury after a breast augmentation, contact the Consumer Alert Now. We could connect you with a competent attorney or help you join a mass tort for compensation.
An Overview of Breast Implants
People choose to have breast implants for several reasons. For some, it is to alter their breasts’ shape, while for others, it is to increase their size. Some people use breast implants to correct unevenness in their breasts, and others after a mastectomy. Breast implantation is a surgical treatment that takes about 60 to 90 minutes to complete. A well-trained and experienced surgeon does it while the patient is under general anesthesia. The procedure involves cutting the skin below the affected breast or at the bottom of its areola and positioning the implant. Surgeons use various methods based on the patient’s body and the size and type of the implant.
There are mainly two types of breast implants: silicone and saline implants. Silicone implants are silicone shells filled with a thick gel-like liquid silicone. After implantation, many women who have had a silicone implant inserted say that it feels a lot more like a natural breast. If in the future the implant ruptures, the patient may not be aware of it. That is why the law recommends breast implants using silicone implants for women above 22 years.
Saline implants, on the other hand, are filled with salty water. If their shell ruptures, the implant collapses, and the salted water will be absorbed by the body, which naturally expels the saline substances. Some saline implants are designed with an inner structure intended to feel more like a natural breast. When compared to silicone implants, saline implants are safer, hence recommended for women above 18 years.
When choosing to have breast implants, women have more factors to consider than the make of implants. The texture of the implants is among those factors. Under this factor, we have two main categories: smooth versus textured. Silicone and saline implants come as textured or smooth. For example, if you prefer smooth, round breasts, the main option available are saline implants. Tear-drop shaped implants are mainly silicone. It is advisable to take time to learn about all these details before making a choice.
Everyone who undergoes breast implantation expects safe results that will allow them to enjoy the augmentation for a long time. However, some people have developed cancer and other severe side effects after breast implantation. Allergan breast implants are among those that have been listed as cancer-causing. Most operations involving breast implants work well, with no side effects or complications after the procedure. But if you have had a breast implant and have developed severe side effects, you may be eligible for compensation for all damages incurred.
Unfortunately, there are defective or dangerous medical products in our markets today, including breast implants. They could give rise to product liability claims if one or more people incur an injury or die after undergoing surgery or using that medical device. The United States Food and Drug Administration keeps an eye on most productions. Still, it is impossible for FDA to flag some products, especially those defective in their design. That is why the injured persons are allowed to join others in filing lawsuits for compensation if they have compelling reasons to prove that a particular medical device caused their injuries.
Allergan Breast Implants and BIA-ALCL
When a person goes through an operation to have a breast implant, they always hope the procedure will change their lives for good. Those who desire larger or fuller breasts hope to enjoy the results for a long time, without becoming sick. Those who undergo the operation after mastectomy wish to look and feel like they did before mastectomy. Unfortunately, breast implants do not always work the way a patient desires. That is the case of some patients who have had an Allergan breast implant.
In 2011, the FDA provided a detailed report connecting breast implants and BIA-ALCL (Cancer of the lymphatic system). From that time, hundreds of patients who had breast implant surgery have been diagnosed with cancer. Some of these cases are severe, and others are fatal. If you are one of those who underwent a breast implant operation and the implants you had are among those that were recalled, you might be eligible for monetary compensation through an Allergan breast implant lawsuit.
What is BIA-ALCL?
In full, BIA-ALCL stands for breast implant-associated anaplastic large cell lymphoma. It is a less common kind of T-cell lymphoma or cancer that affects the human immune system. It develops in scar tissue capsules and fluids surrounding breast implants. Sometimes it spreads throughout the patient’s body. Fortunately, this disease can be cured for most patients. However, it must be diagnosed in time and the appropriate treatment administered. Only a few cases of death have been reported from the illness. BIA-ALCL isn’t a type of breast cancer. But it is likely to occur to women who’ve had silicone or saline breast implants, more so those with a textured surface.
As of July 2019, there were more than 550 reported cases of BIA-ALCL worldwide. About 33 of those women had lost their lives to the disease. The majority of those cases are from women who had undergone breast implant surgery using textured breast implants from Allergan. This number of reported BIA-ALCL cases caused a global recall of textured breast implants from the manufacturer. Since then, cases of BIA-ALCL issues have continued to rise.
In July 2019, the company announced that it had recalled all its textured breast implants. FDA went ahead to ask plastic surgeons to boycott using Allergan breast implants in their future operations. Surgeons were also asked to send any unused implants back to the manufacturing company. The recall was because the FDA’s analysis showed a risk of about 6% of BIA-ALCL for patients who received textured breast implants from Allergan compared to other textured breast implants from other manufacturers.
A few months before the recall, some countries decided to take Allergan products off their markets, more so their tissue expanders and textured breast implants. At the moment, other textured breast implants believed to bear a lower chance of this illness are still in our markets.
Causes of BIA-ALCL
Experts are yet to determine the actual cause of BIA-ALCL. However, they have noted that textured breast implants are more associated with the illness than smooth implants. Scientists attribute this to the fact that textured breast implants have a more extensive surface area for bacteria growth. Infections from bacteria can cause a kind of immune response in the body, which ultimately, though in rare cases, could cause BIA-ALCL. However, it is vital to work on infection prevention, regardless of the type of breast implant you have. Infections are a significant issue as far as breast implants are concerned.
Every operation presents a risk of infections, even breast augmentation. An infection could occur due to various reasons, among them if a procedure were performed in a place that wasn’t clean. Bacteria could also enter the patient’s body during an operation. Other than infection, other problems that could result from breast implant surgery include:
- Skin necrosis
- Blood clots
- Slow wound healing
- Building up of scar tissue, commonly called capsular contracture
- Deflation and rapture of the implant
- Changes in the volume, shape, and sensation of the breast
- Thinning of breast skin and tissue
- Breast discomfort
- Calcium deposits
- Nipple discharge
- Bottoming out or dropping of the breast implant
- The requirement for more surgery
BIA-ALCL develops inside the tissues surrounding a breast implant. But it spreads out to the rest of a patient’s lymphatic system, as well as their lymph nodes. Some of the leading indicators of the illness to watch out for include:
- Continuous pain or swelling around the affected breast implant — Pain and swelling could occur soon or long after the operation, even after the incision has long healed. For some patients, the pain, discomfort, and swelling can occur years after the procedure.
- Capsular contracture that could result in a lump beneath your skin — You could also notice a thick scar tissue close to the implant, which results in a distorted appearance.
- Collection of fluid around the implant
Signs of other complications vary from one patient to another. As mentioned earlier, infection is a significant complication connected to BIA-ALCL. It is essential to be on the lookout for complications and treat those developments soon as they show up. Here is a list of symptoms that should prompt you to call your physician right away:
- Change in the color and shape of your breast
BIA-ALCL also presents some auto-immune symptoms you should watch out for. A silicone breast implant could cause an autoimmune disease in some patients, as reported from a study conducted to prove the connection between silicone breast implants and autoimmune rheumatic diseases. Autoimmune signs that could indicate the illness include:
- Cognitive impairment
- Arthralgias, myalgias
- Dry eyes
- Dry mouth
Silicone implants can also leak from the point of insertion and spread to the entire body. It is a potential risk for a chronic inflammatory illness. If you’ve undergone a breast implant recently or sometime back and are experiencing any of those symptoms listed above, it is crucial to seek immediate medical advice.
How is BIA-ALCL Diagnosed?
As mentioned above, BIA-ALCL is a type of T-cell lymphoma, which refers to cancers forming in the human body’s T cells. These types of cancers grow very fast, according to the American Cancer Society. How ill a person is will be determined by cancer’s stage of development at the time of their diagnosis, plus how aggressive the cancer is. Most of the reported cases were diagnosed between 7 and 8 years after the breast implant operation.
Generally, BIA-ALCL symptoms are not specific, which makes diagnosis complicated. Therefore, it could take time before a patient is diagnosed. However, a lot of information regarding this cancer has emerged over the recent years, making it easier and quicker for experts to establish some standard for diagnosis.
Today, if your doctor suspects that you may have BIA-ALCL, he/she will run some tests to exclude other illnesses that could present similar symptoms. Some of these tests include:
- Aspiration of the fluid collected around the implant, guided by an ultrasound — Your doctor will be checking whether the fluid will have cancer infected T cells, which is a straight indication that you could be having BIA-ALCL.
- Examination on the part around the implant to check for apparent thick scarring
- A close examination of the affected breast for an abnormal mass— If found, your physician will test its tissues for lymphoma by the use of biopsy.
If your doctor suspects that you could be having an autoimmune disease, he/she will conduct numerous blood tests, alongside physical examination and a peek into your health history. Mostly, medics look for clinical signs and symptoms presenting in every person. Your doctors might recommend imaging tests based on the location and type of inflammatory symptoms.
Can BIA-ALCL Be Treated?
Fortunately, BIA-ALCL can be treated. After diagnosing a patient with the illness, doctors can recommend the patient to undergo a PET-CT scan. This imaging test checks for indications of lymphoma in various parts of the body. Even though this is a sporadic type of cancer, it is quite aggressive. It can spread fast and far. Thus, an earlier diagnosis improves your chances of receiving adequate treatment.
If your doctor realizes that the cancer is only in the tissues around one or both of your breasts, he/she may recommend the removal of one of both breasts/implants. If your cancer is barely in its first stage, removing the implant could be enough to stop its progression.
However, if the cancer is already at its second stage or higher, a more effective treatment will be recommended as it can spread very fast. Other than removing the implant, you might have to undergo chemotherapy to stop or slow cancer progression.
If patients present other medical issues linked to breast implants, doctors offer treatment on a case-by-case basis, based on the symptoms the patient is showcasing. They mostly use antibiotics to treat infections. But in severe cases, the patient must undergo surgery to remove the implant that is causing the infection.
After removing the implant, most patients who have acquired an autoimmune disease after undergoing a breast implantation experience great relief from symptoms like fatigue, arthralgia, neurological symptoms, and myalgia.
It is crucial to have a proper diagnosis and design an effective treatment plan if you wish to overcome this disease. Note that treatment can be medical, surgical, or both.
Fortunately, patients can live a normal life after treatment. Even though some patients have lost their lives to BIA-ALCL, the survival rates are very high, especially for patients diagnosed early enough and had their implants removed. If the cancer is diagnosed while still at its first stage, removing the affected implant and cancerous tissues around the affected breast can increase their chances of survival by a higher margin.
However, it is worth noting that cancer treatment is not always 100% effective, even when it is expensive and challenging. Unfortunately, one doesn’t have so many choices whenever they think of having a breast implant. That is why the law requires manufacturers to be very careful only to release safe products to the market. The manufacturer has to exercise caution and test products before these products reach consumers. Failing to do that makes manufacturers responsible if any of their products is defective enough to injure consumers.
For many people, the solution would be to avoid having a breast implant. But remember that risk for contracting BIA-ALCL for patients who have had breast implants is rare. Breast augmentation is generally a very safe treatment. It is essential to understand that there are risks of complications to every operation before undergoing any procedure.
To minimize the risk of infection, illnesses, or implant rupture after the operation, monitor your breasts closely after the procedure. Also, ensure that you follow the surgeon’s aftercare guidelines. If you see or feel any changes, experience symptoms, or signs of an infection, be sure to call your doctor immediately. What is essential is to prevent a disease or cancer progression before it advances to the rest of the body.
Allergan Breast Implant Lawsuits
Extensive studies conducted by scientists since the first case of BIA-ALCL have revealed an increased risk of this illness linked to Allergan’s textured breast implants and tissue expanders. Hundreds of patients who have been affected by these implants have filed lawsuits for compensation against the company and other responsible parties. FDA and WHO have noted BIA-ALCL as a type of cancer common to women who have undergone breast implant operations.
Through these lawsuits, the injured request the responsible parties to at least cater to the cost of having their implants removed and replacing them with safer implants. Even though receiving compensation for the procedure is helpful to these victims, it will not release the suffering and trauma they have had to deal with, plus the painful signs that come with cancer. Again, patients have to undergo an invasive operation and other unpleasant treatments, coupled with the fear of living with a cancer diagnosis.
If you have been affected, seeking legal help may not seem like a good idea considering the suffering you are going through or one you have incurred in the past. However, a lawsuit could lighten your burden. First, it helps to know that you are not experiencing severe side effects alone. Second, it helps to know that the company could be held responsible and compensate the victims’ injuries. In short, a lawsuit will provide both emotional and financial relief during the most challenging moment of your life.
To file a lawsuit against the company, you could join a mass tort case near you. To do that, you need the help of an experienced attorney to guide you through the legal process. You can hire your attorney or contact one among those that are already attached to the case. Your attorney will interview you to gather details of your injury. Your attorney will also advise you on available options. If your injury is directly connected to the mass tort case, your case will be included in the mass tort.
The advantage of joining a mass tort is that mass torts use experts and other professionals and witness testimonies to strengthen their case. Lawyers involved in the case join their resources together to gather enough evidence and prepare a stronger case for their clients. After the conclusion of the case and the alleged at-fault party is found responsible for the victim’s injuries, each victim will receive compensation based on the extent of their injuries.
Find Help Filing an Allergan Lawsuit Near Me
If you underwent a breast implant surgery and were later diagnosed with side effects such as pain, infection, unevenness, or numbness, you may be eligible for compensation by the responsible party. Your surgeon may have used the recalled Allergan breast implant on you. Consumer Alert Now offers help to individuals who might have incurred injuries after receiving a defective breast implant or tissue expanders. If you don’t have an attorney to help you join a mass tort near you, we can connect you to one already involved in the case. We aim to see justice served to victims of corporate neglect. Call us at 800-511-0747 from any of the 50 states and let us help you fight for the compensation you deserve.