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Breast Implant Information

Breast implants are medical devices implanted under breast tissue or under the chest muscle for the purpose of:

Reconstruction done in patients who have had a mastectomy to remove the breast when breast cancer is present
Augmentation, a cosmetic procedure to enlarge the breasts
Revision surgery, done when either reconstruction or augmentation surgery needs to be revised due to problems resulting from the original operation

There are two main types of breast implants:

Saline-filled implants
Silicone gel-filled implants

Various breast implants differ in profile, size, and texture of the shell surface.
Saline-Filled Breast Implants

Saline-filled breast implants are silicone shells into which saline is prefilled before surgery or filled with saline during surgery. They are approved for:

Reconstruction or revision reconstruction following breast cancer surgery for women of any age
Augmentation or revision surgery in a women 18 years old or older

These implants are made by Mentor and Allergan (formerly Inamed).
Silicone Gel-Filled Implants

Silicone gel-filled implants are silicone shells prefilled (before surgery) with silicone gel. They are approved for:

Reconstruction (both primary and revision) for women of any age
Augmentation (both primary and revision) for women 22 years of age and older

Implants are not done for women younger than 18 (saline) or 22 (silicone gel) because the breasts are still developing at a young age.
ALCL Cancer Detection

Anaplastic Large Cell Lymphoma (ALCL) is not breast cancer. It is not cancer found in breast tissue cells. Rather, in women diagnosed with ALCL near implants, it is cancer found in fluid that surrounds the implant or is contained within fibrous scar tissue (not breast cancer tissue) that often develops around a breast implant.

ALCL, according to the National Cancer Institute, is a rare malignant tumor (non-Hodgkin s Lymphoma) that can show up in several parts of the body, including:

Lymph nodes
Skin
Bones
Soft tissue
Lungs
Liver

It is a cancer of the cells of the immune system.
ALCL Cancer Detection Due to Breast Implants

Data are lacking to determine if there is a link between ALCL and breast implants. The U.S. Food and Drug Administration (FDA) conducted a review of the scientific literature published between January 1997 and May 2010. It found 34 women in the United States and 26 cases elsewhere to reach a total of 60 cases worldwide. This is out of hundreds of millions of breast implant patients.

The FDA, which is planning to conduct more studies, concluded:

"Based on all evidence available to us at this time, the FDA believes that women with breast implants may have a very low but increased risk of developing ALCL."

Breast Implants: Saline and Silicone Gel-Filled
Complications of Breast Implants

Many complications from breast implants are possible. The complications may affect women with either saline-filled or silicone gel-filled implants. Some might require surgical or nonsurgical treatments or removal of the implants.

The most common complications that occur locally in patients with breast implants are:

Contracture — Scar tissue normally forms around the breast implant. If this scar tissue contracts, it tightens around and squeezes the implant, possibly leading to discomfort and disfigurement.
Rupture and deflation — It is possible for the casing of the implant to rupture and for the material inside to leak out, leading to deflation of the implant.

Capsular contracture has been defined according to four grades of severity. They are:

Grade I — the breast is normally soft and looks natural
Grade II — the breast is a little firm but looks normal
Grade III — the breast is firm and looks abnormal
Grade IV — the breast is hard, painful, and looks abnormal

Among the many complications that can affect implants are:

Asymmetry (breasts are of different sizes or shapes)
Pain
Atrophy of the tissue
Calcium deposits
Chest wall deformity
Delayed healing of the surgical area
Extrusion of the material through the implant casing
Galactorrhea — milk flow
Granuloma — small area of inflammation
Bruising or redness
Infection, including toxic shock syndrome
Tissue death
Palpability or visibility of the implant
Scarring
Seroma or collection of fluid
Wrinkling or rippling

ALCL and Breast Implants

ALCL or anaplastic large cell lymphoma is an immune system cancer that is in the group of non-Hodgkin s lymphomas. It is a very rare disease in both women and men. In women, the National Cancer Institute ALCL statistics estimate that it occurs in about 1 in 500,000 women annually in the U.S. In women with breast implants, the occurrence is even more rare — 3 in 100 million.

ALCL is not breast cancer when it occurs in the breast. That is, the cancer cells are not in the breast tissue, but in cells between the breast tissue and the implant. The National Cancer Institute defines ALCL as a rare type of malignant tumor of the non-Hodgkin s lymphoma type. It can occur in different parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver. Depending upon the type of ALCL, it is treated either with chemotherapy or radiation

Breast Implant and ALCL Statistics

Women who have breast augmentation (not reconstruction following a mastectomy) number in the hundreds of thousands in the United States.

Breast implant statistics gathered by the American Society of Plastic Surgery for 2009 include:
Breast augmentation procedures done in 2009 — 289,328
Breast augmentation done in 2000 — 212,500
Percent difference between 2000 and 2009 — 36 percent
2009 amount of money spent on breast augmentation surgery — $963,839,020

Breast augmentation by age:

13-19 years old — 8,199
20-29 years old — 86,525
30-39 years old — 103,738
40 years and older — 80,668

Breast Augmentation by U.S. Location in 2009

The number of breast implants done in 2009 in various locations around the country were:

Region 1 — New England and Middle Atlantic: 41,420 (14 percent of U.S.)
Region 2 — East North Central and West North Central: 47,476 (16 percent of U.S.)
Region 3 — South Atlantic: 45,166 (16 percent of U.S.)
Region 4 — East South Central and West South Central: 47,614 (16 percent of U.S.)
Region 5 — Mountain and Pacific107, 652 (37 percent of U.S.)

Women With Breast Implants Who Experience ALCL Symptoms

ALCL (anaplastic large cell lymphoma) is a rare type of non-Hodgkin s lymphoma, a cancer of the immune system. The number of women who get ALCL is about one in 500,000 each year in the United States. The number of women who have breast implants and get ALCL each year in the U.S. is about three in 100 million.
Signs and Symptoms of ALCL

The main symptoms of ALCL in women who have breast implants are persistent swelling and pain in the area near the implant. These symptoms often do not appear until long after the surgery to have the implant, often years later.

The way to diagnose ALCL in women who have symptoms is to do a biopsy of the fluid or scar tissue surrounding the implant. Both form during the healing process.

Because ALCL is very rare, it usually is found unexpectedly in women who have revision surgery for their implants. It is not known as yet which type of implants, saline-filled versus silicone gel-filled, are more likely to be associated with ALCL.

The U.S. Food and Drug Administration (FDA) is recommending that women with breast implants but no symptoms should in general keep their implants, because the number of cases of ALCL is so small. The agency recommends that healthcare professionals should:

Report any cases of ALCL to Medwatch, the FDA safety information and adverse event reporting program. Reports can be made online or by telephone at 1-800-332-1088
Consider a patient might have ALCL when she has late onset, persistent fluid around the implant, then have the fluid and scar tissue biopsied for disease

Women with implants should:

Continue their regular medical care
Monitor their breast implants and see their doctor if they have pain, swelling, or any changes around the implants
Understand that ALCL is very rare and is not breast cancer, but a cancer that grows between the implant and the breast tissue

Breast Implants and ALCL Lawsuits

Have you had a breast implant — either saline or silicone gel-filled — and then been diagnosed with anaplastic large cell lymphoma (ALCL)? If so, you should contact a breast implant lawyer to find out what your legal options are.
Contact an ALCL Breast Implant Lawyer

A qualified lawyer can discuss your individual situation to determine if you have legitimate grounds for a lawsuit. At this time, it is unclear if there is a link between ALCL and breast implants. The numbers of women who get this rare cancer are too small to make a determination. But, it is possible there is a link.

It is in your best interest to contact a lawyer to discuss your options.
What Types of Implants Are There?

There are two types of breast implants, depending upon what they are filled with. The two kinds of implants are:

Saline-filled
Silicone-gel filled

It still is unknown if one type or the other has a stronger association with ALCL. The U.S. Food and Drug Administration (FDA) is establishing a registry to keep track of cases of ALCL in women with breast implants to gather enough data to determine if there is a relationship between the rare cancer and breast implants.
What is ALCL?

ALCL is a rare type of non-Hodgkin s lymphoma, a cancer of the immune system. According to National Cancer Institute ALCL statistics, about one woman in 500,000 is diagnosed per year with ALCL. The number of women diagnosed with ALCL in the U.S. each year who have breast implants is three women per 100 million women.

The National Cancer Institute defines ALCL as a rare malignant tumor of the non-Hodgkin s lymphoma type) that can appear in a number of places in the body. These include:

Lymph nodes
Skin
Bones
Soft tissue
Lungs
Liver

The primary symptoms of ALCL in women with breast implants are pain or swelling near the breast implant. These symptoms often occur long after the surgical implant operation has occurred, frequently years later.
Is ALCL Breast Cancer?

It is important to know that ACLC in women with breast implants is not breast cancer. That is, it is not cancer of the breast tissue, but cancer that appears between the implant and breast tissue in liquid that has accumulated around the implant or in scar tissue that has formed around it.

Breast Implants and Anaplastic Large Cell Lymphoma (ALCL)

The U.S. Food and Drug Administration (FDA) has reported a possible link between breast implants and anaplastic large cell lymphoma (ALCL). If you have breast implants and develop ALCL, contact us for legal help. We may be able to help you collect financial compensation.
What is ALCL (Anaplastic Large Cell Lymphoma)?

ALCL is a type of non-Hodgkin s lymphoma (NHL). It is a cancer of the immune system. ALCL is a rare disease that comes in two forms:

ALCL that affects the lymph nodes and organs
Cutaneous (skin) ALCL

The primary systemic type of ALCL affects children and adults, but it is relatively rare in adults. ALCL occurs in only two to three percent of adults diagnosed with NHL every year. ALCL in children, however, occurs in ten to thirty percent of all childhood NHL.
Breast Implant ALCL Symptoms

In the primary systemic type, the first symptom most patients experience is enlarged lymph nodes. On rare occasions, the disease occurs in the intestines and bones without affecting the lymph nodes. The disease is diagnosed by taking a biopsy from the affected lymph node or organ. After the diagnosis is confirmed, the pathologist tests for the stage of the disease.

In patients with ALCL of the cutaneous type, the disease mainly involves the skin. This is a relatively rare condition that affects mostly older adults. The first symptoms patients will notice are swellings or sores on the skin. A skin biopsy confirms the diagnosis.

Depending upon the type and location of the ALCL, treatment may be chemotherapy or radiation therapy. Some cases of ALCL of the skin may disappear on its own.
Anaplastic Large Cell Lymphoma and Breast Implants

ALCL has been found to occur in a few rare instances in patients who have breast implants. The diseased cells are adjacent to but not in the breast tissue. Therefore, this is not a form of breast cancer. The occurrence of ALCL is three in approximately 100 million women.

At present the numbers are too small to say that the breast implants causes ALCL, but the U.S. Food and Drug Administration is establishing a registry to begin to track the occurrence of the disease in women with breast implants so that data can be accumulated to enable a better understanding of the relationship between the disease and breast implants