Breast Implant Risks

In addition to the risks of anesthesia and surgery in general, there are complications that may result from any surgical procedure that places a foreign object (including a breast implant) in the body. It is not known how frequently the following occur, but the frequency is dependent on both patient and surgical factors.

General Surgical Risks

Hematoma is a collection of blood or a blood clot from a leak in a blood vessel that may form within hours after surgery in the pocket where the implant has been placed. If this happens, swelling, pain, and bruising may result. Large hematomas may have to be drained surgically for proper healing. Surgical drainage may cause scarring, which is minimal in most women.

Infection is a risk associated with any surgical procedure including insertion or removal of a breast implant and requires immediate medical attention. Infections occur in a few percent of women receiving implants. Most infections occur soon after surgery, but they can happen, although rarely, much later. If you notice signs of infection such as pain, redness, swelling, tenderness, fever, or drainage at the operative site, call your surgeon immediately. Infection after any type of surgery can be serious. If the infection does not subside promptly with the appropriate treatment, removal of the implant may be necessary. If that happens, a new device can usually be implanted after the infection has completely cleared.

A few cases of toxic shock syndrome related to breast implants (and not related to menstruation or tampon use) have been reported.(1)

Other Implant-Related Risks

In addition to the surgical risks discussed above, other risks are associated specifically with breast implants. The surgeon should discuss these with you well in advance of surgery.

If possible, a month before the surgery, ask your surgeon for full information on the risks associated with breast implants, including:

• the patient package insert for your specific type of implants,
• the patient information sheet for women considering saline-filled implants, and
• a copy of the informed consent form usually given to the patient prior to surgery for either saline or silicone-gel filled implants.

The adverse effects from breast implants fall into two categories. The first consists of known risks that are clearly associated with these devices. The second consists of problems that have not been scientifically shown to be associated with breast implants but have been reported by some women who have them. Scientists are conducting research to determine if an association does exist between these reported problems and breast implants.

Known Implant-Related Risks

Additional surgery is a risk for women with either silicone gel-filled or saline-filled implants. Surgery may be needed to treat a serious problem with the implant, or to remove a ruptured implant and, if desired, replace it. A recent study found that 24 % of women with breast implants experience adverse events resulting in surgery during the first five years after implantation (silicone and saline implants were combined). The likelihood of needing additional surgery was greater for reconstruction than for augmentation. According to this study, women getting breast implants for reconstruction can expect about a 1 in 3 chance of needing a second surgery within five years; women getting breast implants for augmentation can expect about a 1 in 8 chance of needing a second surgery within five years.(2) Additional surgeries may result in (additional) loss of breast tissue.

Rupture, deflation, and leakage Breast implants are not lifetime devices and cannot be expected to last forever. Some implants deflate (or rupture) in the first few months after being implanted and some deflate after several years; yet others are intact 10 or more years after the surgery.

Magnetic resonance imaging (MRI) may be used for evaluating patients with suspected rupture, deflation or leakage. Discuss this and other options with your doctor.

In addition to the length of time the implant has been in the body, the chance of rupture also increases with injury to the breast. Closed capsulotomy, a technique used to break capsular contracture by squeezing the breast, has also been implicated as a possible cause of breast implant rupture; closed capsulotomy is not recommended by breast implant manufacturers.

Saline-filled implants

Saline implants may be more vulnerable to damage and deflation than gel-filled implants. When a saline-filled implant deflates, it usually happens quickly. Surgery is then required to remove the ruptured implant and replace it, if desired. Since salt water is naturally present in the body, the body will absorb the leaked saline solution from the implant instead of reacting to it as foreign matter.

The rupture rate for saline implants varies and seems to be dependent on many factors, including manufacturing quality standards and length of time since manufacture. It is not known when deflation is most likely to happen. The implant may break due to injury to the breast or normal aging of the implant, releasing the salt water filling.

Silicone gel-filled implants

When silicone gel-filled implants rupture, some women may notice decreased breast size, nodules, uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Other women may experience a rupture and not notice any differences. Plastic surgeons usually recommend explantation if the implant has ruptured, even if the silicone is still enclosed within the scar tissue capsule, because the device is no longer working as intended. If you are considering the removal of an implant and the implantation of another one, be sure to discuss the benefits and risks with your doctor.

The rate at which silicone gel-filled implants rupture is uncertain. However, using different methods for detection, published studies suggest between 5 and 51% of women experience rupture, an enormous range. A study of screening mammograms suggested that 5% of asymptomatic women had experienced “silent rupture” of their implants. Mammography is of limited value in detecting implant rupture. The mammogram readings of rupture were not confirmed by surgical removal of the implant. Robinson et al. studied 300 women who had their implants for 1 to 25 years and had their implants removed for a variety of reasons.(4) They found visible signs of ruptures in 51% of the women studied. Severe silicone leakage — silicone outside the implant was seen in another 20% without visible tears or holes. Robinson et al. also noted that the probability of rupture increases as the implant ages and recommended removal of all gel-filled implants preferably before 8 years of implantation.

A silicone gel-filled implant may rupture but stay contained within the fibrous capsule the body has made around the implant. Silicone gel which escapes the fibrotic capsule surrounding the implant may migrate away from the breast. The free silicone may cause lumps called granulomas to form in the breast or other tissues where the silicone has migrated, such as the chest wall, armpit, arm or abdomen. Some studies indicate that silicone may escape the capsule in 10-20% of rupture cases.(5)

Other Known Risks for all Breast Implants

Capsular contracture is a tightening of scar tissue around the implant. This can sometimes cause pain, hardening of the breast, or changes in breast appearance. Although it seems to occur to some extent in most women with breast implants, there are no reliable data on how often this happens.(6) If these changes are severe, more surgery may be needed to correct or remove the implants.

Calcium deposits may form in surrounding tissue, and may cause pain and hardening of the scar tissue. In some cases, these deposits may need to be surgically removed. Changes in nipple or breast sensation may result from the surgery. These changes may be temporary or permanent. They may affect sexual response and the response of the nipple during breast feeding. A woman whose nipple is removed as part of a mastectomy will not have the ability to nurse.

Interference with mammogram readings can occur with breast implants. This interference may delay or hinder the early detection of breast cancer by hiding suspicious lesions. Implants increase the technical difficulty of taking and reading mammograms. It is important that a woman with breast tissue and a breast implant undergo mammography to detect breast cancer. Mammography requires severe breast compression that could contribute to implant rupture. Special techniques are used to reduce the risk of implant rupture during this compression, and to maximize visualization of the breast tissue during mammography. These techniques are called breast implant displacement views, Eklund displacement views or Eklund views, after the physician who developed them. Women with implants should always inform the receptionist or scheduler that they have breast implants when making an appointment for mammography and tell the radiologic technologist about the presence of implants before mammography is performed. This is to make sure that the technologists use these special displacement techniques and take extra care when compressing the breasts to avoid rupturing the implant.

The displacement procedure involves pushing the implant back and gently pulling the breast tissue into view. Several factors affect the success of this special technique in imaging the breast tissue in women with breast implants. Therefore, the location of the implant, the degree (hardness) of the capsular contracture, the size of the breast tissue compared to the implant and other factors may affect how well the breast tissue can be imaged.

Also, a radiologist may find it difficult to distinguish calcium deposits in the scar tissue around the implant from a breast tumor when he or she is interpreting the mammogram. Occasionally, it is necessary to remove and examine a small amount of tissue (biopsy) to see whether or not it is cancerous. This can frequently be done without removing the implant.

Shifting of the Implant

Sometimes an implant may shift from its original position, giving the breasts an unnatural look and possibly causing pain and discomfort. An implant may become visible at the surface of the breast as a result of the device pushing through the layers of skin. Further surgery is needed to correct this problem. Placing the implant beneath the muscle may help to minimize this problem.

Granulomas

These are non-cancerous lumps that can form when your normal body cells surround the foreign material such as silicone and form lumps. These need to be evaluated by your physician to tell them apart from lumps that might be cancerous and may require a biopsy.

Other problems with appearance could include incorrect implant size, visible scars, uneven appearance, and wrinkling of the implant. An implant might break through the skin, particularly if you have very thin breast tissue over the implant. If your implant has a valve, you also might be able to feel the valve of the implant with your hand. Repeated surgeries to improve the appearance of the breasts and/or to remove (explant) ruptured or deflated protheses may result in a dissatisfactory cosmetic outcome. Women should consider these issues when deciding to have breast implants and carefully discuss their expected cosmetic results with their surgeon prior to surgery.

Other Potential Complications

Some women may experience other potential complications that include breast pain and delayed wound healing.

References

1. Poblete JV, Rodgers JA, Wolfort, FG. Toxic shock syndrome as a complication of breast prostheses. Plast Reconstr Surg. Dec 96(7): 1702-8.
2. Gabriel SE et al. Complications leading to surgery after breast implantation. NEJM 1997;336:679-682.
4. Robinson OG, Bradley EL, Wilson DS. Analysis of explanted silicone implants: A report of 300 patients Ann Plast Surg 1995; 34:1-7.
5. Vinnik CA. Migratory silicon – clinical aspects. Silicone in Medical Devices – Conference Proceedings. 1991 February 1-2; Baltimore, MD: U.S. Department of Health and Human Services, FDA Publication No. 92-4249 (p 59-67).
6. Burkhardt BR. Capsular contracture: Hard breasts, soft data. Clinics in Plastic Surgery 1988;15:521-532.
Source: US Food and Drug Administration, December 8, 1998.

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