Breast implant controversy

From Wikipedia, the free encyclopedia

The use of breast implants has created some controversy in medical circles.

[edit] Rupture

Intracapsular rupture - with capsule created by the body to wall off (silicone implant) foreign object

Extracapsular rupture - Single lumen silicone implants ruptured a few years before their removal in 2004

The FDA states that "implants should not be expected to last a lifetime." When saline breast implants break, they often deflate quickly and can usually be easily removed. The FDA is more concerned about silicone gel breast implants, because when they break they rarely deflate, and the silicone from the implant can leak and migrate outside of the scar tissue that the body creates around the implant. This is known as "extracapsular silicone."

The specific risk and treatment of extracapsular silicone gel is still controversial. In response to these concerns, FDA scientists completed a study on the health effects of ruptured silicone gel breast implants, which was published in the May 2001 Journal of Rheumatology.^[1] The authors reported a significant increase in fibromyalgia and connective tissue disease among women with extracapsular leakage, compared to women whose implants were not broken or whose rupture was intracapsular.

The FDA stated that rupture is a concern because:

1. Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues.
2. The relationship of free silicone to development or progression of disease is unknown.
3. Implant rupture is a device failure - the implant is no longer performing as intended.

A 2003 article by FDA scientists published in The Journal of Rheumatology stated that women with silicone breast implants report more severe pain and chronic fatigue.^[2] Notably, more women with ruptured implants than those with intact implants had debilitating chronic fatigue (75% vs 51%), postexertional malaise > 24 h (77% vs 51%), impaired short term memory (58% vs 38%), and multi-joint pain (77% vs 60%).

Pathology reports of ruptured implants often show giant cell formation indicating an immune response, as well as chronic inflammation. In a 2004 article in Journal of Autoimmunity, scientists reported patients with implants demonstrated statistically significant elevation in anti-silicone antibodies compared with the unimplanted control groups.^[3] The highest anti-silicone antibody levels were measured in implanted women with either frank implant ruptures or leakage of their silicone gel implants.

The age of the implant is an important factor in rupture. The FDA rupture study was superior to previous rupture studies because it was limited to women who had silicone gel implants for at least 6 years and had not removed their implants or reported problems with them. Based on magnetic resonance imaging (MRI) they found that 77% of the women had at least one ruptured implant, even though most had no symptoms and were unaware of the leakage.^[4]

Neither of the US implant manufacturers have collected MRI data on rupture or leakage for women implants for more than 3-4 years. Therefore, it is impossible to determine if the implants that those companies currently sell have a different rupture rate or likelihood of leakage compared to the implants in the FDA study, which included Mentor and Inamed implants as well as implants made by other companies.

Since the research indicates that most ruptures of silicone gel implants are "silent," with no symptoms, the FDA recommends MRIs as the gold standard for detecting rupture. The FDA General and Plastic Surgery Advisory Panel has considered recommending annual MRIs, but determined that the cost would be prohibitive for screening purposes. However, the data from Inamed and Mentor clearly indicate that clinical exams are inadequate to rule out suspected rupture.^[5]

[edit] Other local complications

Other documented complications specific to breast implants include the following:[1][2][3][[4]

1. Capsular Contracture
   Capsules of tightly-woven collagen fibers naturally form around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics, etc..), tending to wall it off. Most of the time, these tissue capsules are soft-to-firm, and unnoticeable. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be painful and distort the appearance of the implanted breast. Bacterial contamination, gel implant rupture or leakage, and hematoma are the main identified factors in these complications. However, the exact mechanism of capsular contracture in most cases is never identified. Correction of capsular contracture ranges from surgical removal of the implant capsule tissue to removal (and possible replacement) of the implant itself. Capsular contracture may happen again after this additional surgery.
   There are four grades of capsular contracture:
   • Grade I - breast normally soft and looks natural
   • Grade II - breast little firm and looks normal
   • Grade III - breast firm and looks abnormal (visible distortion)
   • Grade IV - breast hard, painful and looks abnormal (greater distortion)
2. Hematoma/Seroma
   Hematoma is a collection of blood inside a body cavity and a seroma is a collection of the watery portion of the blood around the implant or around healing. A small scar can form or a rupture may occur if the implant is damaged during draining the incision. Post-operative hematoma and seroma may contribute to infection or capsular contracture.
3. 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 to no feeling in the nipple or breast after surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby.
4. Extrusion
   Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, (when the breast implant comes through the skin). Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.
5. Necrosis
   Necrosis, the death of tissue around the implant, may prevent wound healing and require surgical correction and/or implant removal. A permanent scar may form.
6. Tissue Atrophy/Chest Wall Deformity
   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.

[edit] Mammography

Pressure on the breast (compression) during mammography can cause implant rupture. Breast implants also can interfere with finding breast cancer during mammography, because the implant shows up as a solid white shape, obscuring tumors above or below. In addition to making tumors more difficult to detect, implants cause "false positive" results as well when extensive scarring and calcium deposits mimic the appearance of cancer, making the deposits difficult to distinguish from tumors on a mammogram.^[6] Biopsy may be necessary to determine whether these are cancerous.

Specific mammogram techniques have been developed to ensure that as much breast tissue as possible is examined in the woman with implants. This requires taking extra images, called displacement views, which expose the woman to more radiation. In 2004, Miglioretti and her colleagues published a study in the Journal of the American Medical Association indicating that 55% of breast tumors were not initially detected on mammograms for women with implants, although the extra images were used.^[7]

This compares to about 30% of tumors that were not initially detected for women who did not have breast implants. These tumors were subsequently detected in later mammograms. Another problem is that calcium deposits can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery to biopsy or remove the implant to distinguish these deposits from cancer. Calcium deposits may be felt as modules or bumps under the skin around the implant.

The displacement views do not protect against rupture, which becomes a greater problem as implants age. Dr. Lori Brown, an FDA scientist, published an article in 2004 in the Journal of Women's Health, indicating that the FDA has received dozens of reports of implants rupturing or leaking during mammography.^[8] Sonograms and MRIs can be used to detect breast cancer instead of mammograms, but this adds to the cost of screening and may not be covered by health insurance.

[edit] Systemic illness

Conflicting studies make the issue of systemic illness an ongoing concern for women considering breast implants. Thousands of women have reported that they became ill from their implants, particularly when silicone implants ruptured. Complaints include systemic fungus, neurological and rheumtological problems. Although that information is considered anecdotal, peer reviewed studies indicate that symptoms of many women with implants improve when their implants are removed, as rheumatologist Professor Frank Vasey stated in 2003:

"Epidemiologic studies on silicone implants focused on defined connective tissue diseases as well as undefined symptom complexes. Studies of defined diseases were either negative or showed only a small but statistically significant relative risk. Studies of systemic lupus erythematosus (SLE) and systemic sclerosis did not show an association with silicone breast implants, but studies of symptoms did.. Because of a lack of consistency in methodology of symptom searches and in study findings some reviewers do not believe implants cause systemic problems. Since then, a Dow Corning-funded study (2496 reduction mammoplasty patients versus 1546 silicone breast implanted women, 1/6 of whom had saline-filled silicone envelope implants) has documented that all 28 symptoms were increased in silicone patients (16 of 28 were statistically increased). In a comparison study, there was a statistical correlation between local problems and systemic problems."^[9]

[edit] Rheumatological

A number of existing studies internationally, funded in part by manufacturers, has reported that there is no evidence of increased mortality or defined autoimmune diseases from silicone breast implants. However, the FDA points out that previous studies have not been large enough to answer the question of whether or not breast implants increase the risk of connective tissue disease or related disorders. Several autoimmune conditions, such as scleroderma and Sjogren's, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made. In addition, autoimmune diseases like lupus typically present with relatively subjective complaints such as joint pain, fatigue, muscle aches, and sleep disturbances. Since many of the symptoms characteristic of autoimmune diseases do not require surgery or inpatient care, it is unlikely that women will be hospitalized for them. The outcome measure for many of the previous European studies was women who were hospitalized for connective tissue diseases, and did not include women who were treated on an outpatient basis. Future study designs should consider these factors.

Studies reported by the FDA have shown that some women with silicone gel-filled breast implants produced antibodies to their own collagen. The researchers initially suspected that women with implants and symptoms actually had fibromyalgia. However, they found that 42 percent of symptomatic women with implants formed antibodies against their own B cells. Only 2 percent of healthy women formed autoantibodies, compared with 14 percent of asymptomatic women with implants and 19 percent of fibromyalgia patients. A recent report detailed HLA differences among women in whom inflammatory myopathy develops after they received silicone implants.^[10][11] We do not know as yet if these antibodies cause CTDs and related disorders.

In September of 2005, a Canadian Expert Advisory panel on Breast Implants reviewed available data, heard public concerns and asked questions of manufacturers.^[12] The review echoed the FDA's concerns including recommending further outcome studies on device failure, rupture rates, and long term effects of silicone. The panel found that both companies provided appropriate information to show that silicones are not immunosuppressive materials. However, the panel did note that peer-reviewed literature raises questions about the potential of silicones and/or implant devices to induce autoimmune or hypersensitivity reactions. The Panel recommended to Health Canada that the manufacturers must demonstrate that migrated silicone provides acceptable risks of hypersensitivity and autoimmunity by a critical review of company and literature data and, if necessary, by undertaking studies in animal models.

[edit] Oncological

Scientists from the National Cancer Institute found an increased risk of lung cancer deaths in comparisons with other plastic surgery patients, although the women in the two groups had no difference in smoking habits. However, scientists did not find evidence that implant patients had a higher risk of death from breast cancer or brain cancer as compared with either the general population or other plastic surgery patients.^[13] They had previously reported preliminary data in 2001 indicating that women with breast implants for at least seven years were twice as likely to die of brain cancer and three times as likely to die of lung cancer. ^[14]

[edit] Neurological

In 2006, researchers reported in the Chemistry Analytic Journal that "women exposed to silicone breast implants have platinum levels that exceed that of the general population, and the first report, to date, to document the various platinium oxidation states present in samples from women exposed to silicone breast implants" that may be more toxic. The study found that platinum migrates from silicone implants via the lymphatic and blood systems and may accumulate in bone tissue persisting years after the silicone gel breast implants have been removed. The study also reported that women with silicone breast implants had approximately 100 times higher platinum levels in their breast milk than women with no known platinum exposure. Platinum levels were as much as 1,700 times higher in urine.^[15][16] The article also pointed out that the study was "quickly and aggressively attacked by other chemists, especially those with connections to breast implant makers." Former Inamed consultant, Brook, expressed skepticism of "finding platinum in a highly unstable form never before known to exist in the presence of air or water, as existing in the human body". Similarly, Lane, a Dow Corning scientist, stated that he was "personally disappointed that [the journal] chose to feature this article because the facts are just not right". The study was funded in part by a nonprofit group that has argued to keep silicone implants off the market. The women in the study had their breast implants in the 1980s, and had had them for an average of 14 years. Many of these women had had them removed, generally because of health problems.

[edit] Additional surgeries

Regardless of the type of implant, it is likely that women with implants will need to have one or more additional surgeries (reoperations) over the course of their lives. Common reasons for reoperations include cosmetic concerns, capsular contracture, and rupture.^[6] Reoperation rates are less frequent in breast reconstruction cases. The major implant manufacturers, Mentor and Inamed, both reported that almost half their reconstruction patients underwent additional surgeries within three years to fix implant problems, whether their implants were silicone or saline. The exact statistics are available on the FDA website.

More than 50,000 implant removal procedures were also reported in 2004. In fact, the American Society of Plastic Surgeons reports that in 2000, about 26% of augmentation and 16% of reconstruction surgeries were for replacement of implants – due to capsular contracture, rupture, implant shift, chronic infection, or other causes.^[17]

[edit] References

1. ^ Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS (2001). "Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women". J Rheumatol 28 (5): 996-1003. PMID 11361228 FDA Summary.
2. ^ Vermeulen RC, Scholte HR (2003). "Rupture of silicone gel breast implants and symptoms of pain and fatigue". J Rheumatol 30 (10): 2263-7. PMID 14528527 Abstract.
3. ^ Wolfram D, Rainer C, Niederegger H, Piza H, Wick G (2004). "Cellular and molecular composition of fibrous capsules formed around silicone breast implants with special focus on local immune reactions". J Autoimmun 23 (1): 81-91. PMID 15236756.
4. ^ Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G (2000). "Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama". AJR Am J Roentgenol 175 (4): 1057-64. PMID 11000165.
5. ^ Holmich LR, Fryzek JP, Kjoller K, Breiting VB, Jorgensen A, Krag C, McLaughlin JK (2005). "The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging". Ann Plast Surg 54 (6): 583-9. PMID 15900139.
6. ^ ^{a b} Carol Rados (September-October 2004 issue). Making an Informed Decision About Breast Implants. FDA Consumer magazine.
7. ^ Miglioretti DL, Rutter CM, Geller BM, Cutter G, Barlow WE, Rosenberg R, Weaver DL, Taplin SH, Ballard-Barbash R, Carney PA, Yankaskas BC, Kerlikowske K (2004). "Effect of breast augmentation on the accuracy of mammography and cancer characteristics". JAMA 291 (4): 442-50. PMID 14747501.
8. ^ Brown SL, Todd JF, Luu HM (2004). "Breast implant adverse events during mammography: reports to the Food and Drug Administration". J Women's Health (Larchmt) 13 (4): 371-8; discussion 379-80. PMID 15195650.
9. ^ Vasey FB, Zarabadi SA, Seleznick M, Ricca L (2003). "Where there's smoke there's fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined". J Rheumatol 30 (10): 2092-4. PMID 14528500 Full text.
10. ^ FDA (2004). Breast Implant Consumer Handbook.
11. ^ Young VL, Nemecek JR, Schwartz BD, Phelan DL, Schorr MW (1995). "HLA typing in women with breast implants". Plast Reconstr Surg 96 (7): 1497-519; discussion 1520. PMID 7480270.
12. ^ Expert Advisory Panel on Breast Implants (2005-09-29/30). Record of Proceedings. Health Canada.
13. ^ Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN (2006). "Mortality rates among augmentation mammoplasty patients: an update". Epidemiology 17 (2): 162-9. PMID 16477256.
14. ^ Brinton LA, Lubin JH, Burich MC, Colton T, Hoover RN (2001). "Mortality among augmentation mammoplasty patients". Epidemiology 12 (3): 321-6. PMID 11337605 PDF full text.
15. ^ Lykissa E.D. and Maharaj S.V.M. (April 2006). "Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS". Anal. Chem.. (due publication May 2006). Retrieved on 2006-04-06 (Web).
16. ^ Kaufman, Marc. "Platinum Found in Women With Breast Implants", Washington Post, 2006-04-07, p. A06. Retrieved on 2006-04-08.
17. ^ Diana Zuckerman, Elizabeth Nagelin-Anderson, Elizabeth Santoro (December 2005). What You Need to Know About Breast Implants. The National Research Center for Women & Families.