Saline implants

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Saline filled breast implants

Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion with the goal of being surgically placed via smaller incisions. Current saline devices are manufactured with thicker, room temperature vulcanized (RTV) shells than earlier generations of devices. These shells are made of a silicone elastomer and the implants are filled with salt water (saline) after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed). A single manufacturer (Poly Implant Prosthesis, France) produced a model of pre-filled saline implants which has been reported to have higher failure rates in vivo.

Saline-filled implants were most common implant used in the United States during the 1990s due to restrictions that existed on silicone implants, but were rarely used in other countries. Good to excellent results may be obtained, but as compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, and to be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy breast reconstruction, silicone gel implants are considered as superior. In patients with more breast tissue in whom submuscular implant placement is used, saline implants can look very similar to silicone gel.

Silicone gel implants

Silicone gel-filled breast implants

Thomas Cronin and Frank Gerow, two Houston, Texas, plastic surgeons, developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961. The first woman was implanted in 1962. Silicone implants are generally described in terms of five generations which segregate common characteristics of manufacturing techniques.

First generation

Original Cronin-Gerow Implant from 1963. Note Dacron patch and anatomic “tear drop” shape.

The Cronin-Gerow implants were made of a tear drop shaped silicone rubber envelope (or sac), filled with a thick, viscous silicone gel with a Dacron patch (to reduce rotation of the implant) on the posterior shell.

Second generation

In response to surgeons’ requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner, less cohesive gel and thinner shells. These implants had a greater tendency to rupture or “gel bleed” silicone through an intact implant shell, and complications such as capsular contracture were quite common. It was predominantly implants of this generation that were involved in the American class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s.

Another development in the 1970s was a polyurethane foam coating on the implant shell which was very effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. These implants were later briefly discontinued due to concern of potential carcinogenic breakdown products from the polyurethane. A review of the risk for cancer from TDA by the FDA later concluded that the risk was so small so as not to justify recommending explantation of the devices from individual patients. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States. Second-generation implants also saw the introduction of various “double lumen” designs. These implants were essentially a silicone implant inside a saline implant. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and its volume could be adjusted after placement. The failure rate of these implants is higher than for single lumen implants due to their more complex design. The contemporary versions of these devices (”Becker Implants”) are used primarily for breast reconstruction.

Third & fourth generation

Third & fourth generation implants, from the mid 1980s, represented sequential advances in manufacturing principles with elastomer-coated shells to decrease gel bleed, and are filled with thicker, more cohesive gel. The increased cohesion of the gel filler reduced potential leakage of the gel compared to earlier devices and the more substantial shell improved durability as compared to 2nd generation implants. A variety of both round and tapered anatomic shapes are available from different implants in this group. The anatomic or shaped implants are uniformly impregnated with a textured surface to reduce rotation, while round devices are available in both smooth or textured surfaces.

Fifth generation

Evaluation of “gummy bear” or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been widely used since the mid 1990s in other countries. The semi-solid gel in these type of implants largely eliminates the possibility of silicone migration. Studies of these devices have shown significant potential improvements in safety and efficacy over the older implants with low rates of capsular contracture and rupture.

This is an article about Gummy Bear Implants.

Discerning Breast Augmentation Candidates Choose New, High-Strength Silicone

Gummies Aren’t for Dummies

Discerning Breast Augmentation Candidates Choose New, High-Strength Silicone Gel Breast Implants

April 28, 2005 – If one size doesn’t fit all, how could one choice fit all needs? For more than a decade American women have had no breast implant options. Since the FDA restricted the use of liquid silicone breast implants, women opting for breast augmentation have had only one option: saline breast implants. While saline implants are the right choice for many women, the new high-strength gel implants are less likely to leak and ripple and feel more like natural breast tissue. American women needed more options that offered better results and fewer complications. 

Enter the High-Strength Gel Implant. As technology continued to advance and companies continued to look for a superior implant, a new type of silicone implant began to emerge. These devices are fondly known as “Gummy Bear” Breast Implants, as they feel similar to a soft, squishy – yet solid – material. These implants feel more like natural breast tissue, offer great breast shape, and best of all they are cohesive. This has made them very popular in the scientific studies with doctors, and more importantly with the women who’ve received them. 

“They simply make for better breasts,” said Charlie Sheridan, one of the first people to receive Gummy Breast Implants. “They are soft, sexy and natural! I couldn’t be happier to have my new pair of ‘Bears’.” 

Charlie was not alone in wanting a superior implant. Women who are interested in breast augmentation want nothing less than the very best results. This means the best surgeon, the best brand of implant, and the best shape. Many women will research their options in conjunction with seeking guidance from a respected surgeon and staff. We receive calls from women all across the country that want Dr. Grant Stevens’ expertise, coupled with his ability to use these exciting new Implants. (Only a limited amount of surgeons have been selected and qualified by the FDA to utilize these implants). 

“Gummies aren’t for dummies,” Charlie said, referring to the level of research the patients have done. And indeed, the High-Strength Gel Implants seem to attract highly educated women who value their beauty, value their lifestyle, value their health, and want to retain these attributes as long as possible. Whether it was to exchange existing implants for the Gummy Bear Implants or for first-time implants, women have flown in from across the country just to make sure they got the Gummy versions. 

“We’ve had great results,” said Dr. Grant Stevens of the High-Strength Gel breast implants used in a controlled study. “Women deserve a better implant. They deserve more options. They deserve an implant that is long lasting. But most of all, they deserve to feel good about their bodies, how they look and how they feel – and the High-Strength Gel Implant is just a superior option.” In fact, the implant really does mimic a Gummy Bear candy: it is pliable, but remembers its shape. It is soft to the touch but resilient and it is very natural looking.

Article Courtesy of Marina Plastic Surgery Associates, a Marina Del Rey Breast Augmentation Surgeon

The US FDA in 2006 approved only 2 brands of Silicon gel implants.  These are manufactured by Mentor and Allergan. This landmark decision comes after a 14 year ban on silicon breast implants, and supports the scientific opinion that silicon breast implant technology has finally reached a level of safety required for long term implantation in women.

Breast Implants, Breast Implant Surgery, Breast Job, Plastic Surgery Singapore

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