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(Saline-filled implants were not restricted.) As a deluge of lawsuits upended the implant industry, independent expert groups began reviewing the scientific evidence, looking for links between gel implants and diseases, including breast cancer.
The consensus: Although implants had problems with rupture, deflation, breast hardening, infection, and pain, they did not cause diseases.
The shift "is perhaps the most important change in post-mastectomy breast reconstruction," Memorial Sloan Kettering researchers wrote this year in the Journal of Surgical Oncology.
That's not to suggest implants have become problem-free.
"That data is very strong and gives us as surgeons confidence in recommending implants to women." In 2006, the FDA lifted its restrictions, ruling that the manufacturers Allergan and Mentor provided "reasonable assurance" that their products were safe and effective.
Long before that, however, more women were opting for gel implants, which drove an increase in reconstructive surgeries, studies found.
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"The outer shell is thick and strong and resists rupture," said Copit at Jefferson, demonstrating by closing his office door on a Mentor implant.
Implant innards are now made of a "cohesive" gel that holds its shape. Older implants, in contrast, had a gloppy goo that could ooze out of a hole, creating disfiguring lumps or migrating to other parts of the body.
Both Allergan and Mentor have patient booklets that warn, "Breast implants are not lifetime devices." The lengthy documents explain the nature and frequency of complications such as breast hardening, rupture, and implant removal or replacement, based on the studies that led to approval.Tags: Adult Dating, affair dating, sex dating