The Food and Drug Administration (FDA) has developed a Website for displaying photographs and/or illustrations of breast implant complications.

While the website is not intended to be photographic representation of all breast implant complications, the FDA plans to continue to add photographs and/or illustrations of complications associated with saline-filled and silicone gel-filled implants as they become available.

Patients may be referred to the newest breast implant consumer handbook, which is available in this issue of Vidyya and on the FDA breast implant website at http://www.fda.gov/cdrh/breastimplants/, for a description of potential breast implant complications.

For the items included below, the FDA first defined that complication and then provided an example of a specific case.

Capsular contracture occurs when the scar tissue or capsule that normally forms around the implant tightens and squeezes the implant. It may be more common following infection, hematoma (collection of blood), and seroma (collection of watery portion of blood). There are four grades of capsular contracture - Baker Grades I through IV.

The Baker grading is as follows

Additional surgery may be needed to correct the capsular contracture. This surgery ranges from removal of the implant capsule tissue to removal (and possibly replacement) of the implant itself. Capsular contracture may happen again after this additional surgery.

Photograph 1 below shows Grade IV capsular contracture in the right breast of a 29-year-old woman seven years after subglandular (on top of the muscle and under the breast glands) placement of 560cc silicone gel-filled breast implants¹.

¹Courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

When silicone gel-filled implants rupture, some women may notice decreased breast size, nodules (hard knots), uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Other women may unknowingly experience a rupture without any symptoms (i.e., "silent rupture"). Magnetic resonance imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating patients with suspected rupture or leakage of their silicone gel-filled implant. Plastic surgeons usually recommend removal of the implant if it has ruptured, even if the silicone is still enclosed within the scar tissue capsule, because the silicone gel may eventually leak into surrounding tissues.

When saline-filled breast implants deflate, 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 and is noticed by loss of size or shape of the implant. Some implants deflate or rupture within the first few months after being implanted and some deflate after several years. Breast implants also wear out over time and may deflate. Additional surgery is needed to remove deflated implants.

For silicone gel and saline-filled implants, some causes of rupture or deflation include

• damage by surgical instruments during surgery
• overfilling or underfilling of the implant with saline solution (specific only to saline-filled breast implants)
• capsular contracture
• closed capsulotomy (manually squeezing the breast to break the hard capsule)
• stresses such as trauma or intense physical manipulation
• excessive compression during mammographic imaging
• placement through umbilical incision site (through the belly button)
• injury to the breast
• normal aging of the implant
• unknown/unexplained reasons

Photograph 2 below shows a 30-year-old woman whose left saline-filled breast implant deflated after 5 months². The expected cause was the leaf-valve design of the implant, which is no longer being used by manufacturers.

²Courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

Removal Without Replacement

There is a high chance that women with breast implants will need additional surgery at some point to replace or remove her implant(s) due to problems such as deflation, capsular contracture, infection, shifting, and calcium deposits. Many women decide to have the implants replaced, but some women do not. Those who do not have their implants replaced may have cosmetically undesirable dimpling and/or puckering of the breast following removal of the implant.

Photograph 3 below shows a deformity in the same 29-year-old woman in Photograph 1 above one year after removal of her silicone gel-filled breast implants without replacement³. Patients with large implants, particularly those inserted subglandularly (on top of the muscle and under the breast glands), will have a major cosmetic deformity if they choose not to replace them or to undergo additional reconstructive surgery.

³ Courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.