FDA MedWatch: Breast Implants & Lymphoma

[Guest guest]

We've had several reports over the years of sisters in our Support Group with lymphoma. One friend from San Diego had her lymphoma right where her implant had ruptured.  I've seen estimates that only 10% of adverse effects are reported. Most sick people are too busy trying to stay alive and re-gain some of their health to report to government agencies. If you've been affected, please have someone be sure your 'case' is reported.

With love from Ilena (I haven't forgotten you and our Cause ... just peddling to stay afloat.) 

Ilena's Health Lover Blog 

Breast Implant Awareness 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm241101.htm

Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer

AUDIENCE:  Plastic Surgery, Oncology, Hematology

ISSUE: FDA announced a possible association between saline and

silicone gel-filled breast implants and anaplastic large cell lymphoma

(ALCL), a very rare type of cancer. Data reviewed by the FDA suggest

that patients with breast implants may have a very small but

significant risk of ALCL in the scar capsule adjacent to the implant.

BACKGROUND: In total, the agency is aware of about 60 cases of ALCL in

women with breast implants worldwide. This number is difficult to

verify because not all cases were published in the scientific

literature and some may be duplicate reports. An estimated 5 million

to 10 million women worldwide have breast implants. According to the

National Cancer Institute, ALCL appears in different parts of the body

including the lymph nodes and skin. Each year ALCL is diagnosed in

about 1 out of 500,000 women in the United States. ALCL located in

breast tissue is found in only about 3 out of every 100 million women

nationwide without breast implants.

RECOMMENDATION: In an effort to ensure that patients receiving breast

implants are informed of the possible risk, FDA will be working with

breast implant manufacturers in the coming months to update their

product labeling materials for patients and health care professionals.

The FDA is requesting that health care professionals report any

confirmed cases of ALCL in women with breast implants.

Healthcare professionals and patients are encouraged to report adverse

events or side effects related to the use of these products to the

FDA's MedWatch Safety Information and Adverse Event Reporting Program:

   * Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

   * Download form or call 1-800-332-1088 to request a reporting

form, then complete and return to the address on the pre-addressed

form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA Press

Release, Medical Device Safety Communication, Preliminary FDA Findings

& Analyses, and Questions and Answers about Anaplastic Large Cell

Lymphoma, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm241101.htm

-- Ilena's Health Lover Blog