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Complications Associated With Breast Implants

The Institute of Medicine (IOM) completed its independent, unbiased review of all past and ongoing scientific research study of silicone breast implant safety in June 1999(1) . Among the major findings from this study were that local complications with silicone breast implants were the primary safety issue with breast implants, that these have not been well studied, and that information on these complications is crucial for women deciding whether or not they want breast implant surgery. The IOM report said:

"First, reoperations and local and perioperative [right after surgery] complications are frequent enough to be a cause for concern and to justify the conclusion that they are the primary safety issue with silicone breast implants. Complications may have risks themselves, such as pain, disfigurement, and serious infection and they may lead to medical and surgical interventions, such as reoperations, that have risks. Second, risks accumulate over the lifetime of the implant, but quantitative data on this point are lacking for modern implants and deficient historically. Third, information concerning the nature and the relative high frequency of local complications and reoperations is an essential element of adequate informed consent for women undergoing breast implantation."

There are risks or complications associated with any surgical procedure, such as the effects of anesthesia, infection, swelling, redness, bleeding, and there are complications specific to breast implants. These complications are described below.

Capsular Contracture

Capsular contracture is 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:

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)

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.

In a prospective clinical study of saline-filled breast implants conducted by Mentor, the cumulative, 3-year, by patient rates of a first occurrence of capsular contracture Grades III and IV were 9% for the 1264 augmentation patients and 30% for the 416 reconstruction patients. In a prospective clinical study of saline-filled breast implants conducted by McGhan, the cumulative, 3-year, by patient rates of a first occurrence of capsular contracture Grades III and IV were 9% for the 901 augmentation patients and 25% for the 237 reconstruction patients.

A randomized controlled study comparing silicone gel-filled and saline-filled implants in women undergoing reconstruction reported a 54% contracture rate of Baker Grades III and IV in the silicone gel group after 6 months.(2)

A retrospective study by et al. indicated that 131 of 749 (17.5%) women had at least one surgical procedure over an average of 7.8 years because of capsular contracture.(3) This would not include capsular contracture that may have been severe but did not result in surgery. This study included women who had implants for cosmetic and reconstruction purposes, most of whom had silicone gel-filled breast implants

Deflation/Rupture/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; others are intact 10 or more years after the surgery.

Silicone Gel-Filled Breast Implants — 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.

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.

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. 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.

FDA completed a retrospective study on rupture of silicone gel-filled breast implants.(4) This study was performed in Birmingham, Alabama and included women who had their first breast implant before 1988. Women with silicone gel-filled breast implants had a MRI examination of their breasts to determine the status of their current breast implants. The 344 women who received a MRI examination had a total of 687 implants. Of the 687 implants in the study, at least two of the three study radiologists agreed that 378 implants were ruptured (55%). This means that 69% of the 344 women had at least one ruptured breast implant. Of the 344 women, 73 (21%) had extracapsular silicone gel in one or both breasts. Factors that were associated with rupture included increasing age of the implant, the implant manufacturer, and submuscular rather than subglandular location of the implant. A summary of the findings of this study is also available on FDA's website at http://www.fda.gov/cdrh/breastimplants/studies/biinterview.pdf and http://www.fda.gov/cdrh/breastimplants/studies/birupture.pdf.

et al. studied 300 women who had their implants for 1 to 25 years and had them removed for a variety of reasons.(5) Visible signs of rupture in 51% of the women studied were found. Severe silicone leakage (silicone outside the implant without visible tears or holes) was seen in another 20%. et al. also noted that the chance of rupture increases as the implant ages.

Other studies indicate that silicone may escape the capsule in 11-23% of rupture cases.(6)(7)(8)(9)

Saline-Filled Breast Implants — 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 and is noticed by loss of size or shape of the implant. 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 prospective clinical study conducted by Mentor, the cumulative, 3-year, by patient rates of a first occurrence of deflation were 3% for 1264 augmentation patients and 9% for 416 reconstruction patients. In a prospective clinical study conducted by McGhan, the cumulative, 3-year, by patient rates of a first occurrence of deflation were 5% for the 901 augmentation patients and 6% for the 237 reconstruction patients.

A retrospective study of saline breast implants by Gutowski et al. indicates that 10.1% of women followed for an average of 6 years had at least one implant deflated.(10)

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 (described below) Stresses such as trauma or intense physical manipulation Excessive compression during mammographic imaging Placement through umbilical incision site Injury to the breast Normal aging of the implant Unknown/unexplained reasons

Closed capsulotomy is a technique used to relieve capsular contracture. It involves manually squeezing the breast to break the hard capsule. This has been implicated as a possible cause of breast implant rupture. Closed capsulotomy is not recommended by breast implant manufacturers.

Additional Surgeries

You should understand there is a high chance that you will need to have additional surgery at some point to replace or remove your 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.

In a prospective clinical study of saline-filled breast implants conducted by Mentor, the cumulative, 3-year, by patient rates of a first occurrence of additional surgeries were 13% for the 1264 augmentation patients and 40% for the 416 reconstruction patients. In a prospective clinical study of saline-filled breast implants conducted by McGhan, the cumulative, 3-year, by patient rates of a first occurrence of additional surgeries were 21% for the 901 augmentation patients and 39% for the 237 reconstruction patients.

A retrospective study by et al. shows 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 studied together).(11) According to this study, about 1 in 3 women getting breast implants for reconstruction may need a second surgery within five years, and about 1 in 8 women getting breast implants for augmentation may need a second surgery within five years. These additional surgeries may result in the loss of breast tissue.

Pain

Women may feel pain of varying severity (degrees) and duration (length of time) following breast implant surgery. In addition, improper size, placement, surgical technique, or capsular contracture may result in pain associated with nerve entrapment or interference with muscle motion. You should tell your doctor if you have pain.

Dissatisfaction With Cosmetic Results

Dissatisfying results such as wrinkling, asymmetry, implant displacement (shifting), incorrect size, unanticipated shape, implant palpability, scar deformity, hypertrophic (irregular, raised scar) scarring, and/or sloshing may occur. Careful surgical planning and technique can minimize but not always prevent such results.

Additionally, for saline-filled implants that have 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 ruptured or deflated prostheses may result in an unsatisfactory cosmetic outcome.

Infection

Infection can occur with any surgery. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. Infections with an implant present are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed, and another implant may be placed after the infection has cleared up.

In rare instances, Toxic Shock Syndrome has been noted in women after breast implant surgery, and it is a life-threatening condition. Symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness, and/or sunburn-like rash. A doctor should be seen immediately for diagnosis and treatment.

Hematoma/Seroma

Hematoma is a collection of blood inside a body cavity, and seroma is a collection of the watery portion of the blood around the implant or around the incision. Postoperative hematoma and seroma may contribute to infection and/or capsular contracture. Swelling, pain, and bruising may result. If a hematoma occurs, it will usually be soon after surgery; however, this can also occur at any time after 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 deflation/rupture can occur from surgical draining if damage to the implant occurs during the draining procedure.

Changes In Nipple And Breast Sensation

Feeling in the nipple and breast can increase or decrease after implant surgery. The range of changes varies from intense sensitivity to no feeling in the nipple or breast following surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby. (Refer to the Other Illnesses section for more information on breast feeding.)

Calcium Deposits In the Tissue Around The Implant

Deposits of calcium can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery to biopsy and/or remove the implant to distinguish these deposits from cancer. Calcium deposits may be felt as nodules (hard knots) under the skin around the implant.

Delayed Wound Healing

In some cases, the incision site fails to heal normally or takes longer to heal.

Extrusion

An unstable or compromised tissue covering and/or interruption of wound healing may result in extrusion of the implant, which is when the breast implant comes through the skin. The additional surgery needed to correct this complication can result in unacceptable scarring or loss of breast tissue.

Necrosis

Necrosis is the formation of 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.

Breast Tissue Atrophy/Chest Wall Deformity

The pressure of the breast implant may cause the breast tissue to thin and shrink. This can occur while implants are still in place or following implant removal without replacement.

Interference With Mammography

Interference with mammography due to breast implants may delay or hinder the early detection of breast cancer either by hiding suspicious lesions (wounds or injuries or tumors) or by making it more difficult to include them in the image. Implants increase the difficulty of both taking and reading mammograms. Some women who undergo reconstruction will have some breast tissue remaining, and some have all of their breast tissue removed. It is important that a woman with breast tissue remaining continue to have mammography of that breast, as well as of the other breast, to detect breast cancer.

Mammography requires breast compression (hard pressure) that could contribute to implant rupture. In addition to special care taken by the technologist to reduce the risk of implant rupture during this compression, other techniques are used to maximize what is seen of the breast tissue during mammography. These techniques are called breast implant displacement views, Eklund displacement views, or Eklund views, after the radiologist who developed them. These special implant displacement views are done in addition to those views done during routine mammograms.

Because of the extra views and time needed, women with implants should always inform the receptionist or scheduler that they have breast implants when making an appointment for mammography. They should also tell the radiology technologist about the presence of implants before mammography is performed. This is to make sure that the technologist uses these special displacement techniques and takes 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. The location of the implant, the 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.

Galactorrhea

Sometimes after breast implant surgery, you may begin producing breast milk. In some cases, the milk production stops spontaneously or when medication is given to suppress milk production. In other cases, removal of the implant(s) may be needed.

Footnotes: (1) Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM Report} (2) Asplund, O. Capsular contracture in silicone gel and saline-filled breast implants after reconstruction. Plast Reconstru Surg 1984;73:270-5. (3) SE, Woods JE, O'Fallon WM, Beard CM, Kurland LT, Melton LJ. Complications leading to surgery after breast implantation. New Engl J Med 1997; 336:679-682. (4) Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants in a population of women in Birmingham, Alabama. American Journal of Roentgenology 2000;175:1-8. (5) OG, Bradley EL, DS. Analysis of explanted silicone implants: a report of 300 patients. Ann Plast Surg. 1995; 34:1-7. (6) 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). (7) Duffy MJ, Woods JE. Health risks of failed silicone gel breast implants: a 30-year clinical experience. Plast Reconstr Surg 1994;94:295-299. (8) Berg WA, Caskey CI, Hamper UM, Kuhlman JE, ND, Chang BW, Sheth S, Zerhouni EA. Single- and double-lumen silicone breast implant integrity: Prospective evaluation of MR and US criteria. Radiology 1995;197:45-52. (9) Gorczyca DP, Schneider E, DeBruhl ND, Foo TKF, Ahn CY, Sayre JW, Shaw WW, Bassett LW. Silicone breast implant rupture: Comparison between three-point Dixon and fast spin-echo MR imaging. AJR 1994;162:305-310. (10) Gutowski KA, Mesna GT, Cunningham BL. Saline-filled Breast Implants: A Plastic Surgery Educational Foundation Multicenter Outcomes Study. Plastic Reconstructive Surgery. 1997 (100): 1019-27. (11) SE, Woods JE, O'Fallon WM, Beard CM, Kurland LT, Melton LJ. Complications leading to surgery after breast implantatation. New Engl J Med 1997; 336:679-682.

Current as of March 30, 2001

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537