Stronger & Safer

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The fact that silicone is safe for use inside the body is not in dispute. What remains an understandable concern for some is implant rupture. How often does it happen? How do you know if a silicone implant ruptures? What happens then?

For answers to all your questions about breast implants, our Los Angeles surgeons are here to help. Receive a FREE consultation at select times when you request online, and we’ll let you poke, pull and squeeze silicone implants and learn more about the durability of these devices.

Gummy Bear Implants

The fifth-generation silicone implants that recently received FDA approval are filled with a high-strength, form-stable silicone gel that is the most cohesive ever available. Sientra┬« reports that its Silimed-brand implants have a 3-year rupture rate of 2 to 2.5%. The form-stable implants don’t wrinkle or fold, and since wrinkles and folds contribute to shell failure it’s thought that gummy bear breast implants will prove to have a longevity advantage.

A study published by Dr. Stevens, concluded that these implants have a complication profile similar to other models of silicone breast implants, with a lower rate of capsular contracture. The 5-year follow-up data from the clinical trial supports the low rate of complications and high rate of patient satisfaction that Dr. Stevens’ study reported.

It’s also likely future studies will show that gummy bear implant ruptures, when they do occur, don’t lead to silicone migration. Just think about it for a moment. What happens when you cut a gummy bear? Not much. No loss of shape, no oozing.

Fourth-Generation Silicone Implants

It’s fortunate that silicone gel filled breast implants have been consistently available to women outside the U.S. for many years. Most of the information about implant ruptures comes from European studies.

Breast Implants Marina Del ReyFor the third/fourth-generation implants, the 2 largest manufacturers offer similar information. One company reports a rupture rate for primary augmentation patients of about 3% in an average of 4 years of implantation time, and about 15% in about 11 years. The other’s studies show 0.5% in 3 years and about 10% in 9 years. For more information, read Dr. Stevens’ study of 1012 Mentor MemoryGel Implants.

When silicone breast implants rupture, the filling usually stays within the breast scar tissue pocket, or capsule. A study of Danish women with third/fourth-generation ruptured silicone gel implants supports this fact, showing silicone migration in only about a quarter of cases. Further, for the three-quarters of women with a rupture inside the capsule, only about 10% experienced eventual silicone migration outside the scar tissue pocket. About half those women had experienced recent trauma to the breast or mammography, which may explain some of these findings.

When silicone implants rupture, most women aren’t aware shell failure has occurred. And studies show even experienced physicians are able to detect a rupture less than half the time. This is the reason the FDA calls these incidents “silent ruptures” and recommends women have periodic MRIs to check for them. When a rupture is detected, the manufacturers recommend patients have their implants removed. Though it has not been shown to cause disease, silicone outside the implant shell can lead to lumps, breast hardness and even pain, and it can cause tumor false alarms.