Learn what types of breast implant injuries and complications may be grounds for a medical malpractice or product
Breast implants have been a popular choice for cosmetic enhancement and reconstructive purposes in Tampa for many years. While many individuals undergo this type of cosmetic surgery without complications, others experience problems ranging from infection to implant rupture to certain cancers.
It’s crucial to note that not all issues or complications arising from breast implants provide grounds for lawsuits. However, there are specific instances where legal action may be appropriate.
This article aims to outline the risks associated with breast implants and guide you through the scenarios in which filing a lawsuit may be a viable option.
What are some potential complications of breast implants?
Breast implants come with a variety of potential complications, some of which are common to surgical procedures in general, while others are specific to breast implantation. Here are some of the complications that may arise:
- Capsular contracture. This occurs when the scar tissue around the implant tightens, causing the breast to feel hard and sometimes painful. It can distort the shape of the implant and may require surgical correction.
- Pain and discomfort. Some patients experience prolonged pain in the breasts after the surgery, which may or may not be related to capsular contracture.
- Scarring. While some scarring is expected, keloids or hypertrophic scars can develop, leading to cosmetic concerns.
- Asymmetry. There’s a possibility that the implants may not be symmetrical in size, position or shape, requiring additional surgical intervention for correction.
- Systemic symptoms. Though not universally accepted by the medical community, some individuals report experiencing a variety of systemic symptoms like fatigue, joint pain, and cognitive difficulties, often collectively referred to as “breast implant illness.”
- Implant rupture or leakage. The implant may rupture due to trauma, natural aging of the implant, manufacturer defects, or other complications, leading to the leakage of saline or silicone gel. This often necessitates removal or replacement surgery.
- Nipple sensation changes. The surgery can affect the nerves around the nipple, leading to increased or decreased sensitivity or even a loss of sensation.
- Breastfeeding difficulties. Some women experience challenges with breastfeeding after undergoing breast implant surgery.
- Interference with mammography. Implants can make it difficult to read mammograms accurately, potentially delaying the detection of breast cancer.
- Infection. As with any surgical procedure, there is a risk of infection postoperatively. In severe cases, the implant might need to be removed temporarily until the infection clears.
While some of these complications cannot be anticipated or prevented, others that result from a medical mistake or a manufacturer’s error could be grounds for a lawsuit.
What cancers are associated with breast implants?
Breast implants have been most notably associated with a specific type of non-Hodgkin’s lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This is a rare cancer that develops in the scar tissue surrounding the implant. It is most commonly associated with textured breast implants as opposed to smooth ones.
Another very rare association is with squamous cell carcinoma (SCC). This type of skin cancer has been found in some instances in the capsule surrounding the breast implant. However, the relationship between SCC and breast implants is not yet fully understood and remains a subject of ongoing research.
It’s important to note that breast implants are not known to increase the risk of traditional breast cancer, which is the most common cancer affecting women. Anyone considering breast implants should discuss all potential risks, including the risk of cancer, with their health care provider to make an informed decision.
What is the FDA warning on breast implants?
The FDA recently updated its recommendations concerning breast implants due to reports of squamous cell carcinoma (SCC) and various types of lymphomas found in the scar tissue around the implants. The FDA says it’s aware of 19 cases of SCC, some leading to death, though the cause and risk factors remain unknown.
As of March 22, 2023, health care providers are encouraged to submit case reports to the PROFILE registry, a collaboration between the American Society of Plastic Surgeons, the Plastic Surgery Foundation, and the FDA.
For those considering or who already have breast implants, the FDA advises them to stay informed about the risks and benefits. While there’s currently no need to alter routine medical care, individuals should monitor their implants and consult their health care providers if changes are noticed. Removal of breast implants is not recommended unless symptoms develop.
What breast implant has been recalled?
In 2019, the U.S. Food and Drug Administration (FDA) requested the breast implant manufacturer Allergan recall specific models of its textured breast implants from the U.S. market due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
In response, Allergan conducted a worldwide recall of its BIOCELL textured breast implant products, which included:
- Natrelle Saline-Filled Breast Implants
- Natrelle Silicone-Filled Breast Implants
- Natrelle Inspira Silicone-Filled Breast Implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
The recall also included tissue expanders like Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The action was aimed at removing unused products from suppliers and doctors’ offices.
Lawsuits continue against breast implant manufacturer Allergen and 2 Florida plastic surgeons
In 2019, a federal judge dismissed 2 lawsuits against Allergan, which was accused of being part of an alleged kickback scheme with 2 Jacksonville plastic surgeons, Dr. Loren Clayman and his son, Mark Clayman. The Claymans, who have settled lawsuits with around 290 women for botched surgeries, allegedly benefited from an insurance program by Allergan.
The lawsuits claimed Allergan sold 11,000 pairs of implants to the Claymans’ practice between 2008 and 2015 and paid for subsequent surgeries through warranty claims. The judge ruled that the plaintiffs failed to sufficiently allege that Allergan knew the doctors were engaging in fraud, a necessary precondition for the lawsuit to proceed under Florida law.
The women’s lawyer, Chris Shakib, plans to appeal the decision. Meanwhile, the Florida Department of Health filed its first probable cause finding against Dr. Loren Clayman for allegations of botched surgeries.
What is breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and what are the signs?
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a type of non-Hodgkin’s lymphoma that can occur in the scar tissue and fluid surrounding a breast implant. BIA-ALCL is not a form of breast cancer but is a type of cancer that affects the immune system.
Signs of BIA-ALCL may include the following:
- Swelling around the breast implant, often occurring long after the surgical site has healed
- Pain in the breast or armpit area
- A lump or mass felt in the breast or armpit
- Fluid collection around the implant, which may require imaging studies for detection
- Changes in breast size or shape
- Skin changes, such as redness or rash, over the breast
If you experience any of these symptoms and have a breast implant, it’s crucial to consult with health care professionals for proper evaluation and diagnosis, which may include imaging and possibly a fluid or tissue biopsy. Though BIA-ALCL is rare, early diagnosis and treatment are essential for the best possible outcome.
What is breast implant illness?
Breast implant illness (BII) is a term used to describe a wide range of symptoms that some people report after receiving breast implants. Unlike breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), breast implant illness is not officially recognized as a medical diagnosis by all organizations.
The symptoms reported are diverse and may vary from person to person, making it a controversial and often debated topic within the medical community.
Common symptoms reported by individuals who believe they have breast implant illness include:
- Fatigue and weakness
- Cognitive issues like memory loss or difficulties concentrating
- Joint and muscle pain
- Hair loss
- Dry skin and eyes
- Persistent flu-like symptoms
- Headaches or migraines
- Anxiety and depression
The mechanism causing these symptoms is not well understood, and there is ongoing research to determine whether these symptoms are directly related to breast implants or are coincidental. Some studies suggest that removing the implants (explantation) may relieve symptoms, although scientific evidence is not yet conclusive.
When can you file a breast implant lawsuit, and who may be liable?
To file a successful breast implant lawsuit, you’ll need to prove that your breast implant-related injury resulted from negligence. The specific circumstances under which you can sue can vary, but generally, the following instances may be grounds for legal action:
- Defective product. If the breast implants are found to be defective in design, manufacturing or labeling, the manufacturer could be held liable. For instance, ruptured or leaking implants may be grounds for a lawsuit.
- Failure to warn. Manufacturers are generally required to warn both physicians and patients about potential risks associated with their products, including cancer. If they fail to do so adequately, they may be held liable.
- Medical malpractice. If the surgeon who performed the implant surgery was negligent in their duty of care, a medical malpractice suit could be filed against them. This could include poor surgical technique, failing to inform the patient of risks, or not providing appropriate post-surgical care.
- Wrongful death. In extreme cases where complications from breast implants lead to death, the family may be able to file a wrongful death lawsuit.
Can you sue a breast implant manufacturer?
Yes, oftentimes, the company that manufactured the breast implants is the primary party that may be held liable in a breast implant lawsuit, especially in cases of defective products or failure to warn.
Other potentially liable parties include:
- Surgeon. If the surgeon made a medical error during the procedure or provided inadequate post-op care, they could be held liable for medical malpractice.
- Hospital or medical facility. The organization where the surgery took place may also bear some responsibility, particularly if inadequate facilities or staff contributed to the complications.
Legal proceedings can be complex and time-consuming. If you believe you have a case, consult with an experienced personal injury attorney who specializes in medical malpractice or product liability to discuss your options.
What types of compensation am I entitled to through a breast implant lawsuit?
If you win a breast implant lawsuit, the types of compensation you might be entitled to can vary depending on the nature of the case and the specific harm suffered but may include the following:
- Medical expenses. You could be reimbursed for the cost of any medical treatments or surgeries related to complications from the breast implants, including costs of removal and reconstruction.
- Lost wages. If you’ve had to take time off work to deal with medical issues related to the implants, you may be entitled to compensation for lost income.
- Pain and suffering. Courts may award damages for physical pain and suffering you’ve endured as a result of complications.
- Spousal or consortium claims. Some jurisdictions allow spouses to file claims for loss of consortium, which means compensation for the loss of companionship or a sexual relationship due to medical complications.
- Punitive damages. In some cases where the defendant’s conduct is found to be particularly egregious, punitive damages may be awarded to punish the defendant and deter similar conduct in the future.
- Emotional distress. Emotional or psychological trauma resulting from the complications may also be considered for compensation.
- Quality of life. If your overall quality of life has suffered due to complications, this could be a factor in determining the damages awarded.
- Loss of earning capacity. If the complications have affected your ability to work in the long term, you may be eligible for compensation related to future earnings.
Given the complexity of medical and legal issues surrounding breast implant lawsuits, it’s crucial to consult with an attorney who specializes in these kinds of cases to get a detailed understanding of what types of compensation may be available in your specific case.
Get help from an experienced Tampa medical malpractice attorney
If you or a loved one has experienced complications from breast implants, don’t wait to seek the justice and compensation you deserve. At Lorenzo & Lorenzo, our attorneys are well-versed in medical malpractice and product liability cases, ensuring you’ll be in excellent legal hands.
With years of experience and a proven track record of success, we’ll guide you through every step of the legal process, from gathering evidence to negotiating settlements or taking your case to court.
Contact us today for a free consultation, and let us help you take the first step toward reclaiming your life.
American Society of Plastic Surgeons. (2020). PLASTIC SURGERY STATISTICS REPORT 2020. https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-full-report-2020.pdf
Commissioner, O. of the. (2020, March 24). FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. FDA.
Health, C. for D. and R. (2023a). Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). FDA. https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl#:~:text=A2.
Health, C. for D. and R. (2023b). UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants – FDA Safety Communication. FDA. https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication
Pantazi, A. (n.d.). Federal judge dismisses Jacksonville women’s lawsuits against breast-implant manufacturer Allergan. The Florida Times-Union. Retrieved September 25, 2023, from https://www.jacksonville.com/story/news/2019/08/27/federal-judge-dismisses-jacksonville-womens-lawsuits-against-breast-implant-manufacturer-allergan/4368405007/