BREAST SILICONE IMPLANTS released by FDA — DID WE LEARN ENOUGH OR STILL LEARNING

OVER 14 YEARS THE SILICONE IMPLANT STORY HAS BEEN ON HOLD.  BUT THE MANUFACTURERS HAVE LOBBIED TO REGAIN THE STRONG APPROVAL.  DESPITE THE NEW IMPLANTS UNDER A GUIDELINE OF FURTHER STUDY, THE IMPLANTS CAN BE USED.  ACTUALLY, THEY HAVE BEEN USED OVER THIS PERIOD FOR CANCER OR TRAUMA INJURIES FOR RECONSTRUCTION ALL ALONG. 

THE GROWTH IS EXPECTED TO BE A DOUBLE DIGIT NUMBER FROM NOW ON, UNDER TEN PERCENT A YEAR OVER THE PAST YEARS.  THE MARKET IS  HUGE – GREATER THAN ONE-HALF BILLION DOLLARS PER YEAR.

THE NATIONAL ACADEMY OF SCIENCE'S REPORT REACHED A "NO CONVINCING EVIDENCE" SUMMATION OF THE PROBLEM OF LEAKAGE, RUPTURE, OR DISINTEGRATION CAUSING AN INCREASE OF OTHER DISEASES SUCH AS LUPUS, IMMUNOLOGICAL DISORDERS, OR CANCERS.

IN ONE STUDY HOWEVER, OF NEARLY 1000 WOMEN, ABOUT ONE-THIRD HAD TO HAVE REPLACEMENT OR REMOVAL OF THE "DEVICE."  OF OVER 300 WOMEN, HAVING MRI STUDIES, SHOWED 69 PERCENT WITH LEAKAGE AT ONE POINT.

OVER 260,000 WOMEN HAD BREAST IMPLANTS LAST YEAR WITH THE SALINE-FILLED DEVICES, NOT THE SILICONE TYPE.  NEW RULES ONLY ALLOW WOMEN OVER AGE 22 YEARS OR THOSE NEEDING BREAST RECONSTRUCTION TO USE THE DEVICES.

SILICONE DEVICES HAVE BEEN USED FOR ABOUT THREE DECADES NOW.  THE "HOLD" WAS AFTER MANY WOMEN HAD LEAKAGE, DEFORMITY, PAIN, AND ILLNESS WHEN THE DEVICES FAILED. 

MANY WOMEN HAVE CONTRACTURE, FALLING, SCAR TISSUE, AND DEFORMITY.

ONE COMPANY IS REPLACING RUPTURED DEVICES AND PAYING FOR THE SURGERY AND NEW DEVICES.  HEALTH INSURERS DO NOT ROUTINELY COVER SUCH DEVICES OR SCANS TO CHECK FOR LEAKS, RUPTURES, OR OTHER PROBLEMS.

SO – WHERE ARE YOU ON THE SUBJECT…..TIME TO READ THE "SEQUOIA SEED."

(some portions adapted from SeaTim-FDA contributions)

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