RISKS OF BREAST IMPLANTS

BREAST IMPLANTS CAN BE RISKY

Most of you want to build upon what nature gave you or restore what disease took away.  Breast implants can have enormous benefits but you must be willing to accept the risks.  It may improve the quality of your life.  But there are specific risks to the procedure outside of infection, bleeding and scarring.  The breast implants are designed for augmentation, a cosmetic procedure: reconstruction and replacement of existing implants are called revision 

The implants are filled with saline or silicone gel.  Some are filled with a fixed amount of volume and others are filled during surgery to the desired size.  These implants vary is shape, size and texture. 

In the early 1960s breast implants began being  marketed.  The 1976 FDA and Cosmetic Act required some assurance of safety and effectiveness for medical devices.  The breast implants were “grandfathered” and the manufacturers did not need to provide the FDA with scientific evidence about the safety unless some questions arose.  It was assumed that the implants were biologically inactive and hence not harmful. 

But questions did arise.  In 1991 the FDA required the silicone gel implant makers to show some assurance about their safety if they were to stay in the market.  The following year the FDA called for a moratorium or delay on their uses until the safety could be reviewed. 

Thousands of women filed lawsuits against the manufacturers of these silicone gel implants claiming they had neurological diseases, cancer and connective tissue diseases.  Yet many women were pleased including cancer patients who still wanted a choice of the silicone gel filled implants.

In 2003, the FDA pressured by manufacturers and patients as well, decided to make the devices available and inform all women of the degree of risk involved.  On Nov.17, 2006, the FDA fully approved the use of the more popular silicone-gel implants without reservation.  For information on this go to the FDA web site: www.fda.gov/cdrh/breastimplants.

The implants are extremely durable outside the body and would hold up even if run over by a truck.  But what happens long term in a women’s body.  The capsules could tighten and squeeze the normal scar tissue that forms around the implant.  This hardens the implant like rocks, ripples the skin, and changes the shape of the breast.  It can then cause pain and require removal of the implant.

In addition the implant could rupture and leak out silicone, the result of which is controversial.  Still they kept their shape better than the saline implants after they rupture.  Many of these ruptures were small and silent, without symptoms.  Some of these implants made the nipples and breast tissue become less or more sensitive. 

You must realize that it is likely you would need to have some reoperation over the course of your life.  The capsule could contract, become asymmetrical, rupture or be in a bad position.  Health problems with decrease immunity and neurological symptoms were also experienced.  

 

Realize that breast implants do not last a lifetime.  There may be more costs and problems.  Unfortunately, insurances don’t want to pay to fix what goes wrong.  These implants can rupture during an aggressive mammogram.  They can hide cancerous lesions, and because they cause some calcium deposits around the implants, they can falsely appear as cancers.  Many of the changes to the breast with an implant can’t be undone.

You must have realistic expectations about the implants.  There is no guarantee that the results seen in others will occur for you.  Overall, your health, age, chest structure, the shape and position of the nipple and breast, skin texture, your tendency to bleed, and the luck and skill of your surgical team all play a role in the success of the implant.

Source: FDA consumer reports Nov. 2006

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