Saline and Silicone Breast Implants in Dallas Texas

Breast Implants

Types of Breast Implants

Breast implants are made in many shapes and sizes, with different inner and outer materials. The outer, pliable shell of an implant is thin, solid silicone, and its surface may be either smooth or textured. Textured surface is designed to lessen the formation of scar tissue around the implant.

Smooth-surface implants have a slightly softer shell and are less likely to be felt through the skin and tissue. You should discuss the different implant surfaces with Dallas plastic surgeon Dr. Adams to make sure you choose what is right for you.

Saline Implants

Saline (salt water) is commonly used to fill the breast implant shell. Saline naturally comprises most of the human body, so if the implant should leak which is infrequent (< than 5%) its fluid can be easily and safely absorbed.

Silicone Implants

Recently approved by the FDA November 2006 these implants are now available as an option for breast augmentation.

Cohesive Gel / Gummy Bear Implants

The standard implant in the United States has been saline filled, ever since the FDA moratorium on silicone gel filled breast implants in 1992. The type of implants that were available before the ban are available today as part of an "adjunct study," which is open to patients with congenital deformities or having a revision for particular reasons.

What distinguishes cohesive implants is that the silicone gel is firmer, essentially a soft solid. If a cohesive implant is cut in half, there is no gross movement of gel, and the implant maintains its shape.

The way these are made is that the company uses more "crosslinker" in the making of the implant. The ingredients are the same, but with more crosslinker added, it makes the gel firmer.

The term "cohesive" has been bastardized in recent years. Cohesive breast implants implies form stability, or form retention. That means that in any position, the implant maintains its shape. That is an important distinction, because it means that the shell should not fold, and that it will maintain a particular shape.

Unfortunately, given the recent media attention to cohesive implants, many are using the term to describe "regular" silicone gel implants. Technically, they are correct; all silicone gel is cohesive to some degree. But the term cohesive has always meant form stability, and when patients ask for cohesive gel, it is because they are looking for an implant with those particular characteristics of durability and shape retention. Hopefully, the terminology will be clarified in the coming years.

Implant Shapes

Different implant shapes and textures are available; however, no one implant can work best for every patient, and selection needs to be individualized for every patient.

Dallas plastic surgeon Dr. Adams can help you decide during the consultation with pictures and discussion on what type of implant will work best for you to achieve your optimal results.

What is the current status of breast implants?

Saline breast implants were approved by the FDA in 2000. Silicone gel breast implants are still in the approval process. Since 1992 the only availability of silicone gel implants has been thru the silicone gel adjunct study which made these devices available to breast reconstruction patients, women with pre-existing gel implants for revision and breast augmentation / breast enlargement patients who have saline implant problems or are deemed poor candidates for saline implants.

In the late 1990s the 2 main breast implant companies (Mentor and Mcghan (later Inamed and now Allergan Medical) began their core gel PMA (pre-market approval) FDA studies on silicone gel implants to determine the safety and efficacy of these devices. Inamed Corporation finished their study 1st and went to a FDA panel hearing in October 2003 where they received a vote for approval by the panel. In January of 2004 the FDA made an uncharacteristic decision to deem the Inamed implants "not approvable" without further information. Subsequently, Inamed and Mentor Corporations went to another FDA panel hearing in April 2005. In a strange sequence of event Inamed received a 5-4 vote against approval and the next day Mentor received a 7-2 vote for approval. The Inamed issues surrounded one type of silicone gel implant (style 153) that had much larger rupture rates that their standard round devices. That summer Mentor Corp. received an "approvable letter" from the FDA that states the devices are deemed worthy for approval once certain conditions are met. Concurrently, Inamed discontinued the style 153 implant and amended their PMA and at the end of the summer 2005 also received a similar approvable letter from the FDA. Generally the companies will work with the FDA on these conditions and usually device approval is expected within 6 months. Afetr 15 months on November 17, 2006 the FDA gave final device approval for the round silicone gel implants.

Continue reading about breast implants in Dallas Texas.

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