In the early 1990's it was reported that silicone breast implants were responsible for connective tissue diseases in some women. After a comprehensive evaluation of the evidence for the Association of Silicone Breast Implants with human health conditions, the Institute of Medicine concluded in June that there is "no definitive evidence linking breast implants to cancer, neurological diseases, neurological problems or other systemic diseases."

For more information, go to http://www.fda.gov/cdrh/breastimplants

Capsular Contracture
Capsular contracture is one of the most common complications associated with breast augmentation. It occurs when the scar tissue hardens around the implant. It may be more common following infection, hematoma, and seroma. Capsular Contracture is much less common and less severe with saline implants than with silicone implants.

There are four grades of capsular contracture - Baker Grades I through IV.

The Baker grading is as follows:
Grade I - the breast is normally soft and looks natural
Grade II - the breast is a little firm but looks normal
Grade III - the breast is firm and looks abnormal (visible distortion)
Grade IV - the breast is hard, painful, and looks abnormal (greater distortion)

Grade I and Grade II require no treatment. Grade III is treated by reopening the incision and releasing the capsule. Grade IV requires repositioning the implant and may require implant removal. Capsular contracture may recur after additional surgery.

According to the FDA, in a clinical study of saline-filled breast implants conducted by Mentor, 9% of 1264 women with implants experienced Grades III and IV capsular contracture after 3 years of the study. In a similar study by McGhan, the rate was also 9% (of 901 patients). The rate of contracture in reconstructive patients is higher.

Another FDA study indicated that 17.5 % of 749 women had at least one surgical procedure over an average of 7.8 years because of capsular contracture.(1) This study included women who had implants for cosmetic and reconstruction purposes, most of whom had silicone gel-filled breast implants.

Dr. Jorges Planas, a plastic surgeon in Barcelona, Spain, conducted two studies on women with capsular contracture (a group of 52 women and a group of 24) and found an 83.8% improvement at 1-year follow-up following external ultrasonic treatment. On average, positive, long term results were achieved in less than 8 sessions. Ultrasound can also be used as a preventative method. You may want to discuss this treatment with your surgeon.

Source: Planas J, Cervelli V, Planas G. Five years experience on ultrasonic treatment of breast contractures. Aesth Plast Surg 2001;25:89-93.

Hematoma/Seroma
Hematoma is a collection of blood inside a body cavity, and seroma is a collection of watery blood around the implant or around the incision. Postoperatively, they may contribute to infection and/or capsular contracture. If a hematoma occurs, it is usually soon after surgery; it can also occur after an injury to the breast. While the body absorbs small hematomas and seromas, large ones will require the placement of surgical drains for proper healing. A small scar can result from surgical draining.

Implant displacement
Implants can move out of position at anytime after surgery. If they move only a little, it may not be noticeable. If they move a lot, you may need surgery to put them into position. This is very uncommon except in women who have very large implants. The larger the implant, the greater the chance that it will displace.

Infection
Infection is very uncommon. The risk is about 1% but if it occurs the implants will have to be removed. If infection does occur, it is usually within six weeks of surgery.

Necrosis
Necrosis is the dead tissue around the implant. This may prevent wound healing and require surgical correction and/or implant removal. Permanent scar and/or deformity may occur following necrosis. Factors associated with increased necrosis include infection, use of steroids in the surgical pocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy.

Galactorrhea
Sometimes after breast implant surgery, you may begin producing breast milk. This is more likely if you have previously lactated. The milk production often stops spontaneously or medication may be given to suppress milk production. In other cases, removal of the implant(s) may be needed.

Mammography
Saline and silicone implants affect a mammogram reading. Implants placed below the muscle permit a clearer reading. When implants are below the muscle, 90% of breast tissue is visible. When breast implants are above the muscle, 75% of breast tissue is visible.

Regardless of where placed, breast implants do not interfere with self-exams. They do not interfere with MRI scans or ultrasounds, which are alternatives to a mammogram. No studies have shown a connection between implants and breast cancer (See http://www.pla sticsurgery.org/mediactr/evidence.htm). However, ineffective mammography could result in a higher risk of undetected breast cancer from other causes. If you have a history of breast cancer in your family, breast augmentation may not be an option.

Rippling
Rippling looks like indentations or waviness on the surface of the breast. It is the saline moving inside the implants. In most cases it occurs during movement. According to a 1994 survey (commissioned by implant manufacturers) 12% of women who were dissatisfied with their implants were dissatisfied because of rippling. Rippling is less likely to occur with implants that have a smooth surface. It is more common in implants that are placed above the muscle, especially in women with little or no breast tissue. Rippling can be a result of underfilling the implant.

Sagging
Sagging is less likely in implants placed above the muscle. Because the implant is likely to be higher on the chest than the breast tissue, you may have separate tissue hanging from the firmer implant. Your surgeon may recommend a mastopexy (breast lift) in addition to the augmentation.

Sensation Loss/Change
After surgery, you may have temporary or permanent numbness. There is also possibility of diminished sensation or increased sensitivity. The risk of having permanently numb nipples is roughly 15%.

Implants placed above the muscle may have a greater risk for this as the surgery may interfere with breast tissue near the skin. You can also expect sensation change if your incision is in the aerola. If the surgeon injures the nerves which lead to the nipple area it can lead to temporary or permanent numbness. All incisions have a risk of diminished sensation.

Rupture or Leak
Rupture of Saline Implants
If a saline implant breaks, it will deflate and the salt water will be absorbed by the body. Alert your physician right away as the implants will have to be replaced. Some implants deflate or rupture in the first few months after being implanted and some deflate after several years. You should also be aware that the breast implant may wear out over time and deflate. Additional surgery is needed to remove deflated implants.

In a study conducted by Mentor, 3% of 1264 patients had deflation after 3 years. In a similar study by McGhan, the deflation rate was 5%of 901 women after 3 years. Another study indicates that 10.1% of women followed for an average of 6 years had at least one implant deflated.(2)

Rupture of Silicone-Gel Implants
When silicone gel implants rupture, women may notice decreased breast size, hard knots, uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. According to the FDA, 69% of 344 women had at least one ruptured breast implant. Factors that were associated with rupture included increasing age of the implant, the implant manufacturer, and submuscular rather than subglandular location of the breast implant. A summary of the findings of this study is also available at the FDA's website at http://www.fda.gov/cdrh/breastimplants/studies/biinterview.pdf

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

• damage by surgical instruments during surgery
  
• underfilling of saline (only) breast implant
  
• capsular contracture
  
• trauma, injury, or intense physical manipulation
  
• excessive compression during mammographic imaging
  
• placement through the belly button
  
• normal aging of the implant