Estos nuevos tipos de cáncer se han observado en mujeres con implantes texturizados o lisos con relleno de solución salina o silicón. Estos tipos de cáncer son de manifestación extremadamente rara. La FDA ha reportado casos de un tipo de cáncer de piel y de sangre en las cicatrices que se forman en las áreas cercanas a los implantes de seno. Estos linfomas recientemente reportados son diferentes al linfoma anaplásico de células grandes asociado a implantes mamarios (LACG-IM) que se reportó anteriormente. (Publicado el 27/09/2022)
What is this update?
This update is about the new release of security issued by the FDA about the types of cancer of rare manifestation that is presented in the scars that are formed around breast implants.
Why is it important this update?
For years, the FDA has received reports of damaging events associated with breast implants. The people who make the decision to undergo surgery, reconstruction or breast augmentation should be aware of the risks associated with these implants. The medical staff must also be aware of these risks to provide adequate information to people who are considering implants, and monitor patients who are already placed.
Previously, the FDA reported a possible link between the implants and lymphoma rare manifestation called anaplastic large cell lymphoma (ALCL-IM) and the disease-filled breast implants (BII, for its acronym in English). For more information on this topic, refer to the publications and information XRAY here. From these results, the FDA has monitored more closely the possible side effects associated with breast implants.
This update reports on a type of skin cancer is very rare called squamous cell carcinoma associated with breast implants (CCE-IM) and on the types of cancer of the immune system called lymphomas whose manifestation has been reported in the scars that form a capsule around the breast implants.
What is CCE-IM?
Squamous cell carcinoma (SCC) is the second type of skin cancer is more frequent. The CCE is most often found in the parts of the body exposed to the sun. Although it is very rare, it is known that the CCE can form scars. The CCE-IM is developed in the capsule of the scars that are formed around breast implants. The treatment against the CCE-IM involves surgery to remove the implant and the capsule surrounding it.
For August 2022, in the medical literature had reported 16 cases of people with CCE-IM. September 1, 2022, the FDA had received 10 reports of breast implants associated with CCE-IM.
What is lymphoma?
Lymphoma is a cancer that starts in the cells that fight infections of the immune system called lymphocytes. There are many types of lymphomas.
Scientists are still without a full understanding of the causes of lymphoma. However, people infected with HIV, Epstein-Barr virus or other viruses, which have been exposed to high levels of ionizing radiation, have a family history of lymphoma or who have been exposed to high levels of pesticides, herbicides or other chemicals are at a higher risk of developing lymphoma.
What is the treatment for lymphoma?
The treatment varies depending on the type of lymphoma. Treatments may include chemotherapy, radiation therapy, targeted or immunotherapy.
How do you detect these types of cancer?
The symptoms of the CCE-IM and lymphoma in the sites of breast implants can include any of the following:
- seroma, delayed (accumulation of fluid in the space around the implant that occurs after a year or more after surgery)
- inflammation
- pain
- capsular contracture (scarring around the implant are unusually stiff, begin to shrink and may distort the size or shape of the implant)
How often gives the appearance of CCE-IM or lymphoma in the capsule around the implant?
In a normal year, about 400,000 women undergo surgery for breast implants in the united States. Of that amount, approximately 300,000 undergo this surgery for cosmetic reasons and approximately 100,000 are placed implants for reconstruction surgery after a mastectomy to prevent or treat breast cancer. Currently, it is estimated that 6.5 million people in the united States have breast implants.
In very few cases have been reported manifestation of CCE-IM and lymphoma (different from the ALCL-IM) in the literature or to the FDA and the information in the risk calculation is not available.
| CCE-IM | Linforma | ALCL-IM | |
|---|---|---|---|
| Cases to date | 16 in the literature; 2 reported to the American Society of Plastic Surgeons; 10 reports on breast implants to the FDA | 30 cases in the literature; 12 reports on breast implants to the FDA | 400 cases in the united States (1,227 at the global level) |
| Frequency | 28 (6.5 million in EE. UU.) | 42 (6.5 million in EE. UU.) | 400 (from 6.5 million in EE. UU.) |
| Risks | Unknown | Unknown | 1:2,207-1:86,029* * * * * Varies by the type of implant |
| Average time elapsed from the first surgery when implants | Approximately 20 years | Approximately 20 years | Approximately 10 years |
| Implant surface | Smooth or textured | Smooth or textured | Textured |
| Type of implant | Stuffed with saline or silicone | Stuffed with saline or silicone | Stuffed with saline or silicone |
It is important to know that cases of CCE-IM and lymphomas associated with breast implants are very rare. Approximately 1 person out of 217,000 with breast implants can be diagnosed with CCE-IM, while approximately 1 person 162,500 may be diagnosed with lymphoma. It is equally important to note that it is not clear if these rare types of cancer are caused by breast implants, or are matches.
Context
In response to the information collected by the FDA regarding breast implants, the agency issued a safety alert for the presence of CCE-IM and lymphoma in the scarring around the breast implants. This is not to say that people with breast implants need to be removed. The FDA does not recommend that you perform the surgery to remove the breast implants, unless the person presents with symptoms related to the cancer.
Conclusions
The majority of women with breast implants are happy with the results. However, the breast implants are associated with known risks. Very few people have reported the presence of CCE-IM or lymphoma in the capsule of the scarring around the implant.
These new cancers have been seen in women with textured or smooth implants filled with saline or silicone. These cancers are extremely rare. The FDA has reported cases of a type of skin and blood cancer in the scars that form in the areas near breast implants. These newly reported lymphomas are different from the previously reported breast implant-associated anaplastic large cell lymphoma (ALCL-IM). (Posted 09/27/2022)
What Is This Update About?
This update is about the new safety communication issued by the FDA regarding rare cancers that occur in the scars that form around breast implants.
Why Is This Update Important?
For years, the FDA has received reports of harmful events associated with breast implants. People who make the decision to undergo breast augmentation or reconstruction surgery should be informed of the risks associated with these implants. Medical personnel should also be aware of these risks in order to provide adequate information to people who are considering implants and to monitor patients who have already had them.
Previously, the FDA reported a possible link between implants and a rare lymphoma called anaplastic large cell lymphoma (ALCL-IM) and breast implant illness (BII). For more information on this topic, please see XRAY’s publications and information here . In light of these findings, the FDA has been more closely monitoring possible side effects related to breast implants.
This update reports on a very rare type of skin cancer called breast implant-associated squamous cell carcinoma (BI-SCC) and immune system cancers called lymphomas that have been reported to manifest in the scars that form a capsule around breast implants.
What Is The CCE-IM?
Squamous cell carcinoma (SCC) is the second most common type of skin cancer. SCC most often occurs on parts of the body that are exposed to the sun. Although very rare, SCC is known to cause scarring. SCC-IM develops in the scar capsule that forms around breast implants. Treatment for SCC-IM involves surgery to remove the implant and the capsule around it.
As of August 2022, 16 cases of people with SCC-IM have been reported in the medical literature. As of September 1, 2022, the FDA has received 10 reports of breast implant-related SCC-IM.
What Is Lymphoma?
Lymphoma is a cancer that begins in the infection-fighting cells of the immune system called lymphocytes. There are many types of lymphomas.
Scientists still do not fully understand the causes of lymphoma. However, people who are infected with HIV, Epstein-Barr or other types of viruses, who have been exposed to high levels of ionizing radiation, who have a family history of lymphoma, or who have been exposed to high levels of pesticides, herbicides or other chemicals are at increased risk of developing lymphoma.
What Is The Treatment For Lymphoma?
Treatment varies depending on the type of lymphoma. Treatments may include chemotherapy, radiation therapy, selective therapy, or immunotherapy.
How Are These Types Of Cancer Detected?
Symptoms of IM-SCC and lymphoma at breast implant sites may include any of the following:
- Late seroma (fluid accumulation in the space around the implant that occurs a year or more after surgery)
- inflammation
- pain
- capsular contracture (the scars around the implant are unusually stiff, begin to contract, and may deform the size or shape of the implant)
How Common Is The Appearance Of SCC-IM Or Lymphoma In The Capsule Around The Implant?
In a typical year, about 400,000 women undergo breast implant surgery in the United States. Of that number, about 300,000 have this surgery for cosmetic reasons and about 100,000 have implants placed for reconstruction surgery after a mastectomy to treat or prevent breast cancer. Currently, an estimated 6.5 million people in the United States have breast implants.
The manifestation of IM-SCC and lymphoma (other than IM-ALCL) has been reported in very few cases in the literature or to the FDA and risk calculation information is not available.
| CCE-IM | Linforma | ALCL-IM | |
|---|---|---|---|
| Cases to date | 16 in the literature; 2 reported to the American Society of Plastic Surgeons; 10 reports on breast implants to the FDA | 30 cases in the literature; 12 reports on breast implants to the FDA | 400 cases in the United States (1,227 worldwide) |
| Frequency | 28 (out of 6.5 million in the US) | 42 (out of 6.5 million in the US) | 400 (of 6.5 million in the US) |
| Risks | Unknowns | Unknowns | 1:2,207-1:86,029* *Varies by implant type |
| Average time elapsed since the first surgery when the implants were placed | Approximately 20 years | Approximately 20 years | Approximately 10 years |
| Implant surface | Smooth or textured | Smooth or textured | Texturing |
| Type of implant | With saline or silicone filling | With saline or silicone filling | With saline or silicone filling |
It is important to know that cases of SCC-IM and lymphomas associated with breast implants are very rare. Approximately 1 person in 217,000 with breast implants may be diagnosed with SCC-IM, while approximately 1 person in 162,500 may be diagnosed with lymphoma. It is equally important to note that it is not clear whether these rare types of cancer are caused by breast implants or are coincidental.
Context
In response to information gathered by the FDA about breast implants, the agency issued a safety alert about the presence of SCC-MI and lymphoma in scars around breast implants. This does not mean that people with breast implants should have them removed. The FDA does not recommend surgery to remove breast implants unless a person has symptoms related to cancer.
Conclusions
Most women with breast implants are happy with the results. However, breast implants are associated with known risks. Very few people have reported the presence of SCC-IM or lymphoma in the scar capsule around the implants.
Written by Facing Our Risk of Cancer Empowered
11/04/2022
Original Source: https://www.facingourrisk.org/es/XRAY/FDA-report-on-SCC-in-breast-implants
