Breast Implant FAQ

Frequently Asked Questions (FAQ) and answers about the risk of Anaplastic Large Cell Lymphoma (ALCL) and “silicone sickness” from leaking breast implants.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting breast implant induced injury cases in all 50 states. If you or a loved one has been diagnosed with cancer or had a doctor suggest breast implant removal because of a predisposition of cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Frequently Asked Questions (FAQ)

Overview

What are silicone breast implants?
What products are on the market?
Why were breast implants banned?
When did the FDA lift the ban?
What happened with the safety studies?
Will the FDA recall silicone breast implants?

Leaking Silicone Breast Implants

What are the risks of breast implants?
What are the most common side effects?
What happens when breast implants rupture?
How often do breast implants leak?
What are the symptoms of leaking breast implants?
Can silicone get into breast milk?
Can silicone breast implants cause birth defects?
Do breast implants cause cancer?

Silicone Sickness

What diseases are linked to silicone breast implants?
What is Polymyositis?
What is Dematomyositis?
What is Sjogren’s Syndrome?
What is Scleroderma?
What is Connective Tissue Disease?
What is Lupus?
What is Neurological Disease?

Breast Implant Lawsuits

Have silicone breast implant lawsuits been filed?
Is there a class action settlement?
What was the settlement amount?
Can I still join the class action?
How can a lawyer help?
Do I have a breast implant lawsuit?

What are silicone breast implants?

Silicone gel-filled breast implants were introduced in 1962. They are used to increase breast size or reconstruct the breast after surgery. They have a silicone shell filled with silicone jelly or “cohesive-gel” (known as “gummy bear” implants).

What products are on the market?

Allergan Natrelle Silicone Gel-Filled Breast Implants
Allergan Natrelle 410 Cohesive-Gel Anatomic Implants
Mentor MemoryGel
Mentor MemoryShape
Sientra Silicone Breast Implants

Why were breast implants banned?

The FDA banned all silicone gel-filled implants in 1992 after and manufacturers failed to address concerns about implant rupture and silicone leakage. Silicone breast implants were upgraded to Class III (“high risk”) medical devices in 1988 after thousands of women reported injuries, including cancer and connective tissue disease

When did the FDA lift the ban?

The FDA lifted a 14-year ban on silicone breast implants in November 2006 after manufacturers completed a few clinical trials and promised to conduct even more long-term safety studies. According to the FDA:

“Despite frequent local complications and adverse outcomes, the FDA determined that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use.”

What happened with the safety studies?

Mentor Worldwide agreed to conduct 6 post-marketing safety studies and track 80,000 women with silicone breast implants for 10 years, as a condition of being allowed to return silicone breast implants to the U.S. market. Just 3 years into that study, 79% of women dropped out.

Other manufacturers had similar problems. Allergan “lost track” of 40% of women with silicone breast implants just 2 years into their 10-year safety study, making the studies worthless for rare side effects like cancer, reproductive effects, and connective tissue diseases.

Will the FDA recall silicone breast implants?

The FDA proposed recalling silicone breast implants in 2010 when it became obvious that the studies would not be useful for investigating cancer, birth defects, or connective tissue disease. However, in 2011, the FDA rejected a recall on the recommendation of plastic surgeons.

What are the risks of breast implants?

Breast implants are high-risk devices that do not last a lifetime. Around 20-50% of women must get them removed within the first 10 years. The FDA recommends having an MRI within 3 years of implantation, and every 2 years afterward, to check if the implant is leaking silicone.

What are the most common side effects?

The most common side effects of breast implants are pain, infection, scarring, implant rupture, asymmetry, capsular contracture (breast hardening), visible wrinkling, and needing another operation. The FDA warns:

“Be aware that breast implants are associated with significant local complications, and the longer the devices remain implanted, the more likely a patient is to experience a complication.”

What happens when breast implant rupture?

Silicone breast implants that rupture (break open) will leak silicone into the body. The gel might stay near the implant or in the shell. Silicone might also be absorbed by the body and travel away from the breast. It may be impossible to remove silicone in other parts of the body.

How often do breast implants leak?

Studies estimate that 50% of silicone breast implants rupture within 10 years, 72% by 15 years, and 92% by 20 years. Nearly all develop “gel bleed,” in which silicone passes through an intact (non-ruptured) shell.

What are the symptoms of leaking breast implants?

Leaking breast implants do not always cause symptoms. This is called a “silent rupture.” When symptoms do appear, they may include:

Breast pain
Tingling or burning pain
Hair loss (alopecia)
Muscle pain or weakness
Joint pain or arthritis
Chronic fatigue
Skin rashes
Kidney problems
Sensitivity to light
Oral ulcers
Heart problems
Lung disease
Enlarged lymph nodes
Easy bruising or bleeding
Fever
Infection
And more

Can silicone get into breast milk?

It is unknown if silicone passes from breast implants into breast milk during breastfeeding, but platinum (a byproduct of silicone manufacturing) has been found in breastmilk. Silicone may also be contaminated with low levels of dozens of other heavy metals.

Can silicone breast implants cause birth defects?

There is not enough research to determine if silicone breast implants cause birth defects, which is why the FDA asked manufacturers to conduct studies in 2006. Unfortunately, these studies were so bad, they were completely useless for determining the risk of birth defects.

Do breast implants cause cancer?

Breast implants have been linked to a cancer of the immune system known as Anaplastic Large Cell Lymphoma (ALCL). It it an aggressive type of Non-Hodgkin’s Lymphoma. The FDA received more than 573 reports of ALCL in women with breast implants as of 2019, including 33 women who died. Textured implants have the highest risk of causing cancer. Silicone implants are also linked to more reports of cancer than saline implants.

What disease are linked to silicone breast implants?

Anaplastic Large Cell Lymphoma (ALCL)
Autoimmune disease
Atypical Connective Tissue Disease
Atypical Neurological Disease Syndrome
Cancer
Connective Tissue Disease
Dematomyositis
Fibromyalgia
Granulocytopenia
Heart Failure
Hemolytic Anemia
Jaundice
Kidney Failure
Lupus
Metal poisoning
Myositis
Nephrotic Syndrome
Neurological Disease
Non-Hodgkin’s Lymphoma
Peripheral Neuropathy
Polymyositis
Primary Sjogren’s Syndrome
Pulmonary Hypertension
Raynaud’s Phenomenon
Rheumatoid arthritis
Scleroderma
Systemic Lupus Erythematosus
Systemic Sclerosis
Thrombocytopenic Purpura
Toxic Shock Syndrome
Vasculitis

What is Polymyositis?

Polymyositis is a rare inflammatory muscle disease that causes chronic inflammation, pain, and fatigue. It weakens muscles in many parts of the body, but especially in the shoulders, hips, or thighs. It sometimes involves muscles for swallowing, speaking, or breathing.

What is Dematomyositis?

Dematomyositis is a rare inflammatory muscle disease (similar to polymyositis) that also involves a distinctive skin rash with patchy red lesions on the eyelids, cheeks, bridge of the nose, upper chest, elbows, knees, knuckles, and sometimes hard lumps under the skin.

What is Sjogren’s Syndrome?

Sjogen’s Syndrome is an autoimmune disease that involves inflammation of certain glands. Tear gland (lacrimal gland) inflammation can cause eye irritation, infection, and vision loss. Salivary gland (parotid gland) inflammation can lead to mouth dryness, tooth decay, gum disease, sores, swelling, and infection.

What is Scleroderma?

Scleroderma is a long-term progressive disease that causes skin inflammation, thickening and tightening of the skin, and scar-tissue in the organs. It overlaps with lupus, muscle inflammation, and arthritis.

It is also referred to as Systemic Sclerosis (SS) when it involves organs (esophagus, kidneys, lungs, bowel), blood vessels, and skin.

What is Connective Tissue Disease?

Connective Tissue Diseases (CTD) are autoimmune disorders that commonly cause joint pain, arthritis, skin rash, muscle inflammation, scarring, swelling of the hands (hand edema), skin thickening, dry eyes, dry mouth, nerve disorders, heart or lung problems, and more.

What is Lupus?

Lupus causes chronic inflammation of the skin and sometimes internal organs. The rash causes reddish-purple lesions and scaly patches on the face, neck, scalp, ears, shoulders, forearms, and sometimes the upper torso. Other symptoms may include pain, fatigue, and fever.

What is Neurological Disease?

Silicone breast implants include four neurological diseases that cause progressive nerve damage: Polyneuropathy; Multiple Sclerosis-like Syndrome (MS); Amyotrophic Lateral Sclerosis-like Syndrome (ALS); and Myasthenia Gravis (disease of the neuromuscular junction).

Have silicone breast implant lawsuits been filed?

A growing number of women with textured breast implants have filed lawsuits after they were diagnosed with Anaplastic Large Cell Lymphoma (ALCL), a rare type of immune system cancer. These lawsuits accuse implant-manufacturers of failing to warn about the risk.

In September 2016, a woman from Seattle who was injured by Mentor MemoryGel silicone breast implants filed a lawsuit (PDF) in California. She accused Johnson & Johnson of failing to test the implant for safety after the FDA lifted its 14-year ban in 2006.

In January 2016, another MemoryGel breast implant lawsuit was filed in California by a woman with skin rashes, heavy metal poisoning, fatigue, and nausea due to “systemic toxicity” from her body’s reaction to the “toxic elements contained within the gel of the implants.”

Is there a class action settlement?

In 1995, Dow Corning Corp. offered a $4 billion settlement to resolve more than 17,000 individual lawsuits and a class action lawsuit involving 450,000 women. This settlement sent the company into bankruptcy.

There are now additional class action lawsuits for women with cancer. These lawsuits were filed after Allergan recalled all Biocell® textured breast implants due to the risk of cancer. The FDA linked the recalled implants to 481 cases of ALCL, 12 deaths and a 6-fold increased risk of ALCL compared to similar textured breast implants.

What was the settlement amount?

No settlements have been reached for women who were diagnosed with cancer after being implants with Allergan’s recalled Biocell® textured breast implants.

In 1998, a $3.2 billion class action lawsuit settlement provides payments between $12,000 and $300,000 for women who developed diseases linked to silicone breast implants. The amount depended on their level of disability.

Can I still join this class action?

It may be possible for women with Allergan’s recalled Biocell® breast implants to join a class action lawsuit. These class actions are typically seeking reimbursement for surgery costs to remove and replace the implants.

The Dow Corning class action settlement stopped accepting new claims after December 15, 2010. For women who signed up before that date, the final deadline to submit claims is June 3, 2019. For more information, please contact our law firm or visit www.sfdct.com and www.tortcomm.org.

How can a lawyer help?

You may still be able to file an individual breast implant lawsuit. Our lawyers can review your case for free. We may be able to help you file a lawsuit and seek compensation for your medical expenses, pain and suffering, lost income, permanent injuries, disability, and more.

Do I have a Breast Implant Lawsuit?

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