Breast implants are medical devices used for breast reconstruction or augmentation. They’re implanted under breast tissue or under the chest muscle. In the U.S., two types of implants are approved for use by the FDA: saline-filled and silicone gel-filled. Regardless of the type, the shell thickness, size, shape, and shell surface texture differ.
While complications can occur with any breast implant, those containing silicone are currently under fire after reports suggest a relationship between Allergan BIOCELL textured implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—a rare cancer of the infection-fighting cells of the immune system. Victims of the defective medical devices can file a Louisville silicone breast implant lawsuit.
According to the American Society of Plastic Surgeons (ASPS), cosmetic procedures are on the rise. In 2018, patients underwent 1.8 million cosmetic surgical procedures. Of those, 313,000 were breast augmentations and 101,657 were reconstructions. In just the augmentations, there was a four percent increase from the previous year. In 88% of those procedures, silicone implants were used.
If you believe you’ve developed BIA-ALCL as a result of breast implants, you can take legal action. Our breast implant lawyers can help you seek the compensation you need to recover your losses and get your life back in order.
What Are Silicone Breast Implants?
Silicone is made of silicon, oxygen, and other elements like carbon and hydrogen. The reason this material is used in breast implants is that it is stable at a high temperature, and it’s resistant to sunlight, moisture, aging, and extremes in temperature. The silicone gel used in the implants also feels more like natural breast tissue. Women at age 22 and older can be approved for silicone breast implants.
When a patient elects to have silicone breast implants, they’ll need to regularly visit their plastic surgeon to make sure the implants are functioning properly. Oftentimes, an MRI screening or ultrasound will be conducted to assess their condition.
In the event the gel leaks, it could remain within the implant shell or it could escape into the breast implant pocket. While a leaking implant filled with silicone will not collapse, the consequences can be severe.
Allergan Breast Implant Recall
In late 2018, The Food and Drug Administration (FDA) investigated reports of silicone and saline-filled textured breast implants causing ALCL. Textured implants refer to those that stick to scar tissue capsules. Now, the FDA has requested that Allergan recall their BIOCELL textured breast implants and tissue expanders as a result of Medical Device Reports reporting 573 worldwide cases of BIA-ALCL and 33 related deaths associated with the implants. It’s estimated that BIOCELL textured implants represent less than 5 percent of implants sold in the United States.
Allergan agreed and is pulling all BIOCELL textured implants from the global market. Affected products include Allergan Natrelle Saline-Filled Breast Implants, Allergan Natrelle Silicone-Filled Textured Breast Implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants.
The FDA will continue to collect and evaluate data collected from individuals with breast implants and BIA-ALCL. They will release new information as it becomes available, which you can find here.
What to Do If You Have Allergan BIOCELL Breast Implants
If you have Allergan breast implants and haven’t been diagnosed with BIA-ALCL, you may be concerned about the possibility. In a situation where a medical device has been recalled, it’s important to know what to do, so you can take proactive measures for your health.
While the FDA does not recommend removal of the implants because the risk of cancer developing is low, speak with your health care provider. Based on your discussion with them, you’ll be able to decide how best to proceed depending on your unique situation.
With any medical device, it’s a good idea to keep a record of the manufacturer, device identifier, and implant model number. You can use that information to see if your implants are on the FDA’s recall list.
It’s also important to recognize the signs and symptoms of a problem. The main symptoms of BIA-ALCL include persistent swelling or pain in the area of the breast. Symptoms typically develop years after the implant’s initial placement. While these symptoms are not only related to breast implant lymphoma, if you have any of the following you should seek medical care as soon as possible:
- Pain in the breast or around the implant
- Swelling of the breast
- Fluid buildup in or around the breast
- Lumps developing in the breast
- Misshapen or asymmetrical appearance
- Hardening of the implants
- Redness around the breast
- Unexplained weight loss
The list above is not conclusive. If you have any concerns, contact your doctor. They will run diagnostic testing to determine what’s going on. Evaluation for BIA-ALCL typically includes a physical examination, imaging, or assessment of the fluid around the implant.
If you have been diagnosed with BIA-ALCL and have breast implants, it’s crucial to get in touch with a Louisville silicone breast implant lawyer. Building a case against a medical device manufacturer company can take time. The sooner we can begin looking into your situation, the faster your claim can get filed.
Filing a Textured Breast Implant Lawsuit
Even though the Allergan BIOCELL breast implants were recalled in July 2019, lawsuits regarding the development of medical conditions are nothing new. Between the 1980s and 1990s, class action lawsuits were filed after approximately 450,000 women sustained injuries from their breast implants. Evidence showed that the Dow Corning Corporation implants contributed to tissue disease. Lawsuits have also been filed for silicone implants that ruptured and leaked. Billions of dollars have been awarded in compensation to victims of defective breast implants over the years.
When it’s discovered that any medical device is defective, anyone who has suffered injuries or losses can take legal action. The majority of textured breast implant lawsuits are filed against the manufacturer. Claims typically revolve around the concepts of strict liability, failure to warn, negligence, breach of warranties, or fraud. Depending on your circumstances, your lawyer will be able to determine what to base your claim on.
With a case of strict liability, you’ll need to be able to prove that the manufacturer sold a dangerous product, intended the product to arrive to you unaltered, and you were harmed by the dangerous condition. With a failure to warn claim, it needs to be shown that the manufacturer knew or should have known about the risks of having the breast implants, but failed to let consumers know. With a breach in warranty, the implant would have had to perform differently than as promised by the manufacturer.
When a case involves a consumer product like breast implants, strict liability claims typically replace negligence claims. In some cases, claims can include both. In order to prove negligence, your lawyer will need to prove that the manufacturer owed you a duty of reasonable care, they breached that duty, the breach caused your injuries, and you suffered as a result of your injuries.
Recover with Thomas Law Offices
If you’ve been diagnosed with BIA-ALCL and you have breast implants, you may be owed compensation for your economic and noneconomic losses. To find out if you have the grounds to file a Louisville silicone breast implant lawsuit, get in touch with our legal team today. We’ll review your circumstances and recommend a course of action.