Keeping a Breast

Posted Thursday, September 13, 2007 to PROCEDURES > Breast

Posted by The Original Anti-Aging & Cosmetic Surgery Magazine

Breast implant surgery is a major step. Now women can feel more confident going ahead with their surgery following the FDA's recent approval of saline breast implants. Anita Catalano reports.

Earlier this year the Food and Drug Administration (FDA) approved the use of saline breast implants made by the Mentor Corp and McGhan Medical - the first time the FDA has approved any brands of saline implant.

The approval follows years of study and research by the major implant manufacturers, Mentor and McGhan.

The number of women undergoing breast implant surgery has increased dramatically in the last few years. The American Society of Aesthetic Plastic Surgery estimates that the number of breast augmentations has increased by 25 per cent between 1997and 1998.

The reasons women seek breast implant surgery are wide and varied, but most cosmetic surgeons agree there is a link to with self-esteem and body image.

Following the FDA approval, cosmetic and plastic surgeons will use saline implants manufactured by McGhan and Mentor. If the patient wants to use an implant by another manufacturer she must be enrolled in an IDE study which is reviewed and approved by the FDA.

A breast implant is a sac of silicone elastomer (rubber) which is surgically implanted either under or above the chest muscle, then filled with saline.

Depending on the desired shape the patient wishes to achieve, a round or contoured implant may be chosen.

McGhan and Mentor offer a number of different types of implants depending on the existing shape of the breast. The choice of implant is usually a joint decision between the patient and surgeon.

Implants come in a variety of shapes, surface textures and sizes. Textured surface implants were designed to reduce the risk of capsular contraction (see below). Mentor offers two types of saline filled implants: the Saline-Filled and Spectrum. The Saline-Filled family of implants has a self-sealing valve located on the front of the implant that is used for filling the device. The Spectrum family has a valve on the back of the implant that allows saline to be added following surgery.

All McGhan Medical implants have a self-sealing valve that is used for filling the device. Depending on the style, the filling valve may be located on the front or back of the implant. McGhan Medical also offers implants in a variety of shapes and textures.

As for other implants, American women will have to wait. In May this year, the UK based Medical Devices Agency issued a warning recommending that women have their purified soybean oil implants removed. Health authorities were concerned that the implants may carry some toxic effects.

How is breast implant surgery performed?

Breast implants are either placed under the major muscle in the chest or on top of the muscle and under the breast glands.This usually depends on the stature of the woman and shape and size of her existing breasts.

There are three common incision sites: under the arm (axillary), around the nipple (periareolar), or within the breast fold (inframammary). According to the FDA the umbilical or endoscope incision site is not recommended.

Surgery usually involves general anesthesia and is performed in a doctor's surgery center or hospital. The surgery lasts up to two hours. If the incision is made under the arm, the surgeon may use a miniature camera and a small instrument to create a space for the implant (endoscope).

The implant is placed in the pocket, filled with saline and positioned.

Recovery varies according to the patient and whether she experienced any complications with her operation. Patients will feel tired and sore for a few days following surgery and breasts may remain swollen, sore and sensitive for around a month. It is normal for breasts to feel a little tight.

Most women are able to return to work a few days after their surgery.

Tell me about the risks

1. Capsular contracture Symptoms: When the scar tissue that normally forms around the implant tightens and squeezes the implant. This condition may be more common following infection, hematoma, and seroma (collection of watery portion of blood) Treatment: Usually corrective surgery is needed, but in more severe cases replacement of the implant is required. In two separate studies carried out by Mentor Corp and McGhan Medical both reported that around 9 % of women suffered some form of capsular contracture. Another study published in the New England Journal of Medicine revealed that 131 of the 749 women studied had at least one surgical procedure over a seven-year period because of capsular contracture.

2. Rupture and Leakage Symptoms: Many women fail to understand that breast implants are not meant to last a lifetime. Some can change after a few months of being implanted while others can remain in tact for 10 years. Saline-filled breast implants deflate when the saline solution leaks either through an unsealed or damaged valve or through a break in the implant shell. Implant deflation can occur immediately or progressively over a period of days, months or years and is noticed by a loss of size or shape of the implant. Treatment: Deflated or ruptured implants usually require surgery, and may require replacement of implant. One study has noted 10% of women followed for an average of 6 years had at least one implant deflated.

3. Infection Symptoms: Any surgery carries a risk of infection. In rare cases, there may be signs of infection a few days or weeks after surgery.

Treatment: A course of antibiotics may be required or in extreme cases replacement of the implant.

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