If you or someone you loved was harmed due to a faulty breast implant, a lawsuit may be filed against the manufacturer – or less often, against the plastic surgeon. Whether you undergo breast augmentation surgery for cosmetic or reconstructive reasons, you should expect the procedure to be safe. You shouldn’t have to discover one day – perhaps a decade later – that the implants inside your body have left you fighting a deadly disease. Yet that is the horrifying reality that many women have discovered, as emerging research has now shown that some breast implants can cause a rare form of lymphoma.
Frequently Asked Questions
What Types of Breast Implants Are There?
Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.
There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, shell, shape (contour), and surface texture.
Can Breast Implants Cause Breast Cancer?
The Food & Drug Administration (FDA) has received hundreds of reports of a rare disease being diagnosed in women who have had breast implants. There’s even a term for the condition: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Note that BIA-ALCL is not breast cancer, but rather a type of non-Hodgkin’s lymphoma, a cancer of the immune system. Research suggests that your risk of developing this rare lymphoma may depend on what kind of breast implants you have.
For now, the FDA states there is no link between the type of fill in the implant – either silicone or saline – and the risk of developing BIA-ALCL, but they note that this has not been evaluated in a large, well-designed study yet. There have always been reports of the possible dangers of silicone-filled implants, but nothing has ever been proven regarding their possible dangers. However, the FDA does note that textured implants carry a far greater risk of causing BIA-ALCL, with a much smaller number of BIA-ALCL cases stemming from smooth implants.
Who Makes Textured Breast Implants in the United States?
A number of companies manufacture prosthetic breast implants sold on the U.S. market. Current manufacturers of FDA-approved breast implants include:
- Allergan (formerly called Inamed and McGhan), which makes both smooth and textured versions of its Natrelle implants
- Mentor World Wide LLC, part of the Johnson & Johnson Family of Companies, which makes both smooth and textured implants under well-known brand names such as MemoryGel and MemoryShape
- Sientra, Inc., which makes silicone gel breast implants with both smooth and textured surfaces
- Ideal Implant Incorporated, which manufactures smooth implants but not textured ones
Already, Allergan and Mentor Worldwide are facing lawsuits due to the risk of lymphoma and other complications due to their implants.
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
According to the World Health Organization, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a T-cell lymphoma that can develop following breast implants. Anaplastic Large Cell Lymphoma is a type of non-Hodgkin’s lymphoma, a cancer of the cells of the immune system. It can occur in many different parts of the body, including the lymph nodes and skin. Even though BIA-ALCL is found in the breasts of some individuals (cis- and transgender women) with breast implants, it is not the same as breast cancer.
The main symptoms of BIA-ALCL are persistent swelling or pain in the vicinity of the breast implant. These symptoms may occur well after the surgical incision has healed, often years after implant placement.
Some of the most concerning symptoms to watch out for include:
- Pain in the breast or around the implant
- Lumps that develop in the breast
- Swelling of the breast
- Misshapen or asymmetrical appearance of the breast
- Fluid buildup in or around the breast
If you find yourself experiencing any of these symptoms of ALCL, it’s important that you get medical care right away. This isn’t a complete list of all possible breast implant lymphoma symptoms. You might also notice changes such as:
- Hardening of the implants or the surrounding tissue
- Redness of the skin surrounding the breast
- Swollen or enlarged lymph nodes, especially in the neck, armpit, or groin area
- Night sweats
- Loss of appetite
- Unexplained weight loss
- Pain in other areas besides the breast, including the chest, back or abdomen
Ultimately, any changes you notice in your breasts or your overall health could indicate a serious medical condition. In the case studies reported in the literature, BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. The illustration below shows the location of the ALCL in these reports. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule. [Modified from Thompson et al, 2010]
What Are the Odds of Developing BIA-ALCL Due to a Breast Implant?
There have now been around 800 reports of BIA-ALCL occurring worldwide, with 457 of those cases occurring in the United States. This means the chances that a woman will develop BIA-ALCL due to a breast implant is between 1 in 3,000 or 1 in 30,000. Experts say that BIA-ALCL typically occurs about a decade after the implant was first inserted.
Exactly why these implants have led to increased risk of BIA-ALCL is not completely clear. One theory is that the increased surface area on the textured implant can offer more of a foothold for bacteria that is introduced during surgery, leading to long-term inflammation and disease. Other theories state that particulates in the tissue that forms around the implant, particularly silicone particles, could be to blame.
How Can a Doctor Detect BIA-ALCL?
Typically, this happens when patients begin noticing symptoms like fluid buildup. Doctors collect samples of this fluid for testing – and the test results reveal the presence of malignant T-cells. More generally, doctors may use a number of different tests to diagnose non-Hodgkin’s lymphoma, such as:
- Physical exams
- Chest X-rays
- Computed tomography (CT) scans
- Magnetic resonance imaging (MRI) scans
- Ultrasound imaging tests
- Positron emission tomography (PET) scans
What Breast Implants Have Been Recalled?
The following implants have been recalled as of July 24 2019:
- Allergan Natrelle BIOCELL Textured Products:
- Allergan Natrelle Saline-Filled Textured Breast Implants
- Allergan Natrelle Silicone-Filled Textured Breast Implants
- Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants
- Allergan Natrelle 133 Plus Tissue Expander
- Allergan Natrelle 133 Tissue Expander with Suture Tabs
The recall affects implants that were manufactured between July 2014 and June 2019, and affects nearly 250,000 devices in the United States alone. The FDA classifies this as a Class 1 recall, indicating that the use of these devices may result in serious injury or death.
The FDA states that the risk of BIA-ALCL with the Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL compared with other textured implants marketed in the United States, and 12 deaths have already been reported. Allergan has also announced that it will cover the costs of new implants for women with Biocell implants who wish to replace them up until July 24, 2021, however, they will not pay for the cost of surgery.
Can Textured Tissue Expanders Also Cause Cancer?
Tissue expanders are used to stretch the skin before a breast reconstruction surgery, or for scar revision. They are temporary implants, intended to be replaced with a standard implant in time.
Unfortunately, the FDA believes that tissue expanders with certain types of textured surfaces may also pose a risk to consumers. Since tissue expanders are only to be used for 6 months, there is no firm data to say whether this limited exposure could increase the risk of cancer in users. However, there are many tissue expanders on the market that do not use a textured surface, and it is recommended that they be used instead
Who Is Liable for a Defective Breast Implant?
You may have questions about who should be held liable if you have a defective breast implant. This will depend on the particulars of your case, and how exactly you have been affected by the faulty implant.
In a case against the manufacturer, you may wish to file a claim of strict liability, failure to warn, or fraud. This can mean proving that the manufacturer knowingly sold the implant to you in a dangerous condition, or failed to warn consumers about risks that they knew their product posed to someone’s health.
If the issues stemming from your breast implant arose because of negligence on the part of the plastic surgeon who implanted them, then that would likely fall under the category of medical malpractice. Surgeons do not typically qualify to be distributors of a product, and therefore any fault with the product itself would have to lie with the manufacturer. Ultimately, speaking with a skilled attorney can help you determine who is at fault, and how you can prove negligence or malpractice.
Do I Qualify to File a BIA-ALCL Lawsuit?
You may have a breast implant ALCL cancer lawsuit if you:
- Underwent a breast augmentation surgery, regardless of whether it was reconstructive or cosmetic, and
- Developed the rare BIA-ALCL form of lymphoma, even if your diagnosis occurred many years after getting implants
Get in Touch
Whether your breast implants contained saline or silicone gel, or whether they had textured or smooth surfaces, you had the right to expect these medical devices to be safe. You didn’t deserve to develop this disease or to endure the pain and stress it has caused your family. What you do deserve now is help to get the compensation and justice you deserve. Don’t hesitate to contact our team of lawyers at McEldrew Purtell today by filling out our form or calling 1-866-694-5578. We are hard-working lawyers for hard-working people.