Re: What You Need to Know About Breast Implants by Zuckerman and...

[Guest guest]

Great ARTICLE!!

>

> _http://www.center4research.org/implantfacts.html_

> (http://www.center4research.org/implantfacts.html)

>

>

> What You Need to Know About Breast Implants

>

> By Zuckerman, PhD; Nagelin-, MA; and

> Santoro, RN, MPH

>

> January 2007

>

>

> In 2005, more than 360,000 women and teenagers underwent surgery to have

> their breasts enlarged with silicone or saline implants,_1_

> (http://www.center4research.org/implantfacts.html#1) and experts estimate

that about 46,000

> breast cancer patients had implant surgery after mastectomy. _2_

> (http://www.center4research.org/implantfacts.html#2)

>

> The popularity of breast augmentation has more than tripled since 1997, when

> there were just over 101,000 of these procedures._3_

> (http://www.center4research.org/implantfacts.html#3)

>

> More than 50,000 implant removal procedures were also reported in 2004._4_

> (http://www.center4research.org/implantfacts.html#4) Given these statistics,

> it is not surprising that in spite of the increasing number of women with

> breast implants, debate continues to swirl about their safety. Many women are

> justifiably confused by the conflicting information they hear. The following

> summary provides the facts about what is known and not known about the risks

of

> breast implants.

>

> After a brief history of breast implants in the U.S., we will answer the

> following questions:

>

> * What are the known risks?

> * What happens when breast implants break?

> * Do breast implants make women sick?

> * What are other concerns?

> * What if I need to get my implants removed?

> * Are there newer, safer implants?

> History of Implants in the US

>

> Breast implants made with silicone envelopes and filled with silicone gel or

> saline (salt water) were first sold in the United States in the 1960's, but

> sales were relatively slow until the 1980's. By 1990, however, almost one

> million women had undergone breast implant surgery, even though no safety

> studies had been published. Most of those women had silicone gel breast

implants,

> which the plastic surgeons preferred.

>

> Although most medical products must be proven safe and effective before they

> can be sold in the U.S., that was not true for implanted medical devices

> sold before 1976. The Food and Drug Administration (FDA) did not require

that

> companies selling silicone breast implants prove that their implants were

safe

> until 1991 †" after they had been in use for almost three decades. For the

> first time, the media started to report about women with implant problems,

and

> quoted doctors who were concerned about implant safety. When the studies were

> provided to the FDA, the safety data were found to be inadequate to warrant

> FDA approval.

>

> The FDA did not require implant makers to prove that their saline implants

> were safe until 2000, when, despite high complication rates, the FDA approved

> saline breast implants for the first time.

>

> Silicone gel breast implants were approved for the first time in November

> 2006. Between 1992 and 2006, silicone implants were restricted to clinical

> trials that were primarily for cancer patients and women with broken

implants.

> Patients were required to be informed that the implants were not approved by

> the FDA and to be regularly evaluated by their plastic surgeons as part of

the

> study, in order to provide safety data intended to help all women with gel

> implants. Although silicone gel breast implants made by two manufacturers

were

> approved in November 2006, there are still restrictions. For example, they

> are only approved for women over the age of 22, because younger women are

still

> developing physically and emotionally.

>

> What are the known risks?

>

> Reports of complications among women with implants have been published in

> medical journals and discussed at public FDA meetings. There are a number of

> short-term and long-term risks that any woman thinking about getting breast

> implants or about removing or replacing older implants needs to be aware of.

>

> " Local complications " refer to problems that occur in the breast area that

> are obviously related to the breast implants or the surgery. Common

> complications include infection and other surgical risks, chronic breast pain,

changes

> in sensitivity, capsular contracture, breakage and leakage, necrosis (skin

> death), the need for additional surgery, and " cosmetic " problems (such as

> dissatisfaction with how the breast looks with the implant).

>

> Studies of saline breast implants and silicone gel breast implants conducted

> by implant manufacturers have shown that within the first three years,

> approximately three out of four reconstruction (breast cancer) patients and

almost

> half of first-time augmentation patients experienced at least one local

> complication †" such as pain, infection, hardening, or the need for

additional

> surgery. _5_ (http://www.center4research.org/implantfacts.html#5)

>

> For example, among reconstruction patients:

> * 46% of women with silicone gel implants and 21% with saline implants

> underwent at least one re-operation within three years;

> * 25% of silicone patients and 8% of saline patients had implants

> removed; and

> * 6% of silicone patients and 16% of saline patients experienced breast

> pain. _6_ (http://www.center4research.org/implantfacts.html#6) , _7_

> (http://www.center4research.org/implantfacts.html#7)

> Complication rates were lower, but still substantial, for augmentation

> patients. The FDA has a consumer handbook with descriptions of common

> complications as well as photographs, available to consumers at

> _http://www.fda.gov/cdrh/breastimplants/indexbip.html_

> (http://www.fda.gov/cdrh/breastimplants/indexbip.html)

>

> In addition to the risks from anesthesia, surgical risks include infection

> and hematoma (blood or tissue fluid collecting around an implant), both of

> which can range from mild to severe. Surgical risks are highest immediately

> around the time of surgery, but complications can require additional surgery

> later, which will have similar risks to the initial surgery. A woman may need

to

> face these surgical risks several times if she decides to have broken or

> damaged implants replaced with new ones.

>

> Other local complications include loss of nipple sensitivity or painfully

> sensitive nipples. Some women are dissatisfied with the cosmetic results of

> breast implants, because their breasts look or feel unnatural or

asymmetrical,

> or they can hear a " sloshing sound " from saline-filled implants. Problems

like

> these can potentially interfere with sexual intimacy.

>

> Scar tissue that forms naturally around any implant or foreign body can, in

> some cases, become hard or tight around the implant. This common problem is

> called capsular contracture. The scar tissue is inside the body, but it can

> cause the breasts to become very hard and misshaped, and it leads to

discomfort

> that ranges from mild to severely painful.

>

> Several researchers have shown that bacteria or mold can grow in saline

> implants,_8_ (http://www.center4research.org/implantfacts.html#8) and have

> expressed concerns about the bacteria or mold being released into the body if

the

> implant breaks. What effect that might have on a woman, or a nursing baby,

> has not been studied.

>

> What happens when implants break?

>

> All breast implants will eventually break, but it is not known how many

> years the breast implants that are currently on the market will last. Studies

of

> silicone breast implants suggest that most implants last 7-12 years, but some

> break during the first few months or years, while others last more than 15

> years.

>

> In a study conducted by FDA scientists, most women had at least one broken

> implant within 11 years, and the likelihood of rupture tends to increase over

> time._9_ (http://www.center4research.org/implantfacts.html#9) Silicone

> migrated outside of the breast capsule for 21% of the women, even though most

> women were unaware that this had happened.

>

> Implant makers were required to study breakage and provide their studies to

> the FDA. Short-term studies of today's saline implants suggest that between

> 3-9% break within the first three years, and one implant manufacturer's study

> of their silicone gel implants found that between 3-20% break within three

> years. _5_ (http://www.center4research.org/implantfacts.html#5) ,_10_

> (http://www.center4research.org/implantfacts.html#10) A Danish study of

ruptured

> silicone gel implants suggests that most last for ten years, but by the time

> they are 11-20 years old, most will break, and after 20 years the few that

are

> still intact will break._11_

> (http://www.center4research.org/implantfacts.html#11)

>

> Silicone Migration: Research has shown that silicone gel in implants can

> break down to liquid silicone at normal body temperatures, and there are

reports

> of silicone leakage and migration from implants to the lymph nodes and other

> organs._12_ (http://www.center4research.org/implantfacts.html#12) What

> happens if liquid silicone migrates to the lungs, liver, or other organs? A

> study published by the Royal Academy of Medicine in Scotland found that a

woman

> with a broken silicone gel implant in her calf was coughing up silicone

> identical to the kind in her implant._13_

> (http://www.center4research.org/implantfacts.html#13) This has potentially

serious implications for women with breast

> implants, since silicone gel breast implants are considerably larger and

> closer to the lungs than calf implants.

>

> Do breast implants make women sick?

>

> A more controversial question is whether breast implants cause diseases or

> illnesses, and not just problems in the breast area.

>

> Auto-immune diseases. Several reports have concluded that there is no

> evidence that implants cause systemic disease._14_

> (http://www.center4research.org/implantfacts.html#14) , _15_

> (http://www.center4research.org/implantfacts.html#15) , _16_

(http://www.center4research.org/implantfacts.html#16) These

> reports, however, relied on research that focused on autoimmune or

> connective-tissue diseases in women who had implants for a relatively short

time -

> ranging from a few months to a few years. Since connective-tissue and

autoimmune

> diseases may take many years to develop and be diagnosed, studies that

include

> women who had implants for such a short time cannot be used to determine

> whether or not breast implants increase the long-term risks of getting these

> diseases.

>

> Studies conducted after these reports were published indicated that implants

> may be linked to auto-immune diseases. For example, FDA scientists conducted

> a study of women who had silicone gel breast implants for at least seven

> years and found that those with leaking implants were significantly more

likely

> to report fibromyalgia, a painful auto-immune disease._17_

> (http://www.center4research.org/implantfacts.html#17) The risk of

fibromyalgia remained even

> after controlling for patient's age, implant age, and implant manufacturer.

> These researchers also found that women with leaking silicone implants were

> significantly more likely to report a diagnosis of at least one of the

following

> painful and debilitating diseases: dermatomyositis, polymyositis,

> Hashimoto's thyroiditis, mixed connective-tissue disease, pulmonary fibrosis,

> eosinophilic fasciitis, and polymyalgia.

>

> Do implant patients who have auto-immune symptoms feel better if their

> implants are removed? A study of 95 women who had silicone gel-filled breast

> implants and rheumatologic symptoms such as joint pain, found that the

symptoms

> improved in 97% (42 of 43) of the women who had their breast implants

removed.

> In contrast, rheumatologic symptoms worsened in 96% (50 of 52) of the women

> who did not have their implants removed._18_

> (http://www.center4research.org/implantfacts.html#18) In addition, a

university researcher has reported that

> silicone stimulates an immune response, and cellular analyses indicate that

> these responses are associated with atypical forms of connective tissue

> disease._19_ (http://www.center4research.org/implantfacts.html#19)

>

> A study of Danish women who had breast implants for an average of 19 years

> found that they were significantly more likely to report fatigue,

Raynaud-like

> symptoms (white fingers and toes when exposed to cold), and memory loss and

> other cognitive symptoms, compared to women of the same age in the general

> population._20_ (http://www.center4research.org/implantfacts.html#20)

>

> Despite reporting that women with implants were between two and three times

> as likely to report those symptoms, the researchers, who were funded by a

> silicone manufacturer, concluded that long-term exposure to breast implants

> " does not appear to be associated with " autoimmune " symptoms or diseases. "

>

> Cancers. A study by National Cancer Institute (NCI) scientists found a 21%

> overall increased risk of cancer for women who had implants for at least

> seven years, compared with women of the same age in the general

population._21_

> (http://www.center4research.org/implantfacts.html#21) The increase was

> primarily due to an increase in brain, respiratory tract, cervical, and

vulvar

> cancers. More research is needed to draw any conclusions, however. There is

no

> research evidence that implants cause breast cancer.

>

> Death. A more recent NCI study found that women who had breast implants for

> at least 12 years were more likely to die from brain tumors, lung cancer,

> other respiratory diseases, and suicide compared with other plastic surgery

> patients._22_ (http://www.center4research.org/implantfacts.html#22)

Augmentation

> patients were not more likely to smoke than other plastic surgery patients,

> so the difference in respiratory diseases did not appear to be due to

> smoking. However, more research is needed to better control for relevant

health

> habits. Three Scandinavian studies have reported that women who had breast

> implants for augmentation were three times more likely to commit suicide

compared

> to women in the general population._23_

> (http://www.center4research.org/implantfacts.html#23) , _24_

(http://www.center4research.org/implantfacts.html#24) ,

> _25_ (http://www.center4research.org/implantfacts.html#25)

>

> What are other concerns?

>

> Breastfeeding. According to the Institute of Medicine (IOM), women with any

> kind of breast surgery, including breast implant surgery, are at least three

> times as likely to have an inadequate milk supply for breastfeeding._14_

> (http://www.center4research.org/implantfacts.html#14) Concerns about the

safety

> of breast milk have also been raised, but there has not been enough research

> to resolve this issue. A study of a small number of women with silicone gel

> breast implants found that the offspring born and breastfed after the mother

> had breast implants had higher levels of a toxic form of platinum in their

> blood than offspring born before the same women had breast implants. _26_

> (http://www.center4research.org/implantfacts.html#26)

>

> Breast Cancer Detection. Breast cancer is the most common type of cancer

> among women, and since mammograms have been shown to detect breast cancer

> earlier and thus save lives, the question of whether implants interfere with

> mammograms is important.

>

> There are several ways in which implants have the potential to delay

> detection of breast cancer:

> * Although mammography can be performed in ways that minimize the

> interference of the implants, approximately 55 percent of breast tumors will

be

> obscured in women with implants._27_

> (http://www.center4research.org/implantfacts.html#27)

> * A study by FDA scientists indicates that silicone or saline implants

> can rupture when women undergo mammograms, and for this reason, women who

> fear implant rupture may forego mammograms._28_

> (http://www.center4research.org/implantfacts.html#28)

> * The accuracy of mammograms tends to decrease as the size of the

> implants increase in proportion to the size of the woman's natural breast.

> Research findings on whether implants lead to a delay in breast cancer

> diagnosis have been inconsistent, but patients have reported such delays._28_

> (http://www.center4research.org/implantfacts.html#28) A delay in diagnosis

could

> necessitate more radical surgery or be fatal.

>

> Cognitive Problems. Women with implants have raised concerns about memory

> loss, difficulties with concentration, and other cognitive problems. FDA's

> analysis of industry data found a significant increase in neurological

symptoms,

> such as poor concentration, for women who had silicone implants for two years

> compared to their symptoms just prior to getting implants. These differences

> were maintained even when the women's ages were statistically

> controlled._29_ (http://www.center4research.org/implantfacts.html#29) Some

experts believe

> these symptoms could be related to the small amounts of platinum that are

> used to make silicone gel breast implants, since potentially toxic levels of

> platinum have been found in the blood and urine of women with implants._26_

> (http://www.center4research.org/implantfacts.html#26) Unfortunately, there

is

> no well-designed published epidemiological research to determine whether

> there is an association between these complaints and breast implants.

>

> Financial Costs. The initial surgery for breast implants is the first, but

> not always the greatest expense for implant patients. On average, implants

> last 7-12 years, and each replacement adds to the cost. Even if the implant

> itself is replaced for free, or if the surgeon offers his or her services for

> free, the cost of the medical facility, anesthesiology, and other expenses

can

> still cost many thousands of dollars for each surgery. These expenses are

> affordable for some women, but not for others, and they are certainly more

> likely to be burdensome for a woman whose implant breaks after just a few

months

> or years.

>

> When the FDA approved silicone gel breast implants in November 2006, it

> stated that women with these implants should have a breast MRI three years

after

> getting silicone implants and every two years after that._30_

> (http://www.center4research.org/implantfacts.html#30) The purpose of the

MRIs is to

> determine if the silicone gel breast implants are ruptured or leaking,

because there

> are often no symptoms. Breast MRIs usually cost at least $2,000, and at some

> facilities they cost more than $5,000. It is important to remove silicone

> implants if they are ruptured, to avoid the silicone leaking into the breast

or

> lymph nodes. That is an additional expense of at least $5,000, and can be

> $10,000 or more.

>

> Saline implants do not require MRIs to check for leakage, and do not usually

> cost more than $5,000 to remove. The cost of MRIs and the additional cost of

> removing leaking silicone makes silicone implants substantially more

> expensive than saline.

>

> What about health insurance? Typically, cosmetic surgery is not covered by

> health insurance, and problems resulting from cosmetic surgery are also

> excluded from coverage. Health insurance will not pay for MRIs to check for

> silicone leakage for augmentation patients. In some states, major health

insurance

> providers do not insure women with breast implants. Some insurers will sell

> health insurance to women with implants, but charge them more, and some

> insurers will not cover certain kinds of illnesses - or any problems in the

breast

> area - for women with breast implants. Obviously, this can be a terrible

> problem for women who are diagnosed with breast cancer or any other illnesses

that

> are excluded, whether or not those diseases are related to the implants.

>

> What if I need to get my implants removed?

>

> Women who have implants sometimes decide to have them removed because of

> complications, disappointment with the cosmetic result, or, perhaps, concern

> about the long-term health risks. Some surgeons discourage patients from

> removing their implants. This may be because they don't share the patient's

> concerns, or because they know that some patients will be very unhappy with

their

> appearance after the implant is removed. (See photo #3 at

> _www.fda.gov/cdrh/breastimplants/breast_implants_photos.html_

> (http://www.fda.gov/cdrh/breastimplants/breast_implants_photos.html) .) Women

with ruptured silicone implants often

> lose breast tissue as part of the removal surgery. If silicone has leaked

> into the breast tissue, the resulting removal surgery may be similar to a

> mastectomy. (See second photo at

> _www.breastimplantinfo.org/what_know/dz_fda_test_oct03.html_

(http://www.breastimplantinfo.org/what_know/dz_fda_test_oct03.html)

> .)

>

> The plastic surgeon who performed the original surgery is not necessarily

> the best choice for removing the implant. Removal can be much more

complicated

> and expensive than the original surgery, especially after a silicone gel

> implant has broken. Some plastic surgeons are very experienced at removal and

are

> especially skilled at getting the best possible cosmetic result. Most

> surgeons who specialize in removal recommend removing the implants " en bloc, "

which

> means that the implant and the intact scar tissue capsule surrounding it are

> all removed together. This helps remove any silicone that may have leaked

> from a broken gel implant, and also helps remove silicone or other chemicals

> that may have " bled " from the silicone outer envelope.

>

> Are there newer, safer implants?

>

> As part of new research studies, plastic surgeons sometimes offer " gummy

> bear " breast implants, named after gummy bear candies because the implants

are a

> thicker, more cohesive silicone gel. Since the shell and gel in these newer

> models are thicker than most other silicone gel implants, it is possible that

> they might be less likely to break or leak into the body.

>

> However, new implants often have risks that are not immediately obvious.

> Unfortunately, no studies have been published in medical journals to show

> whether these new implants are proven safer than other silicone gel breast

implants

> for long-term use. At this point, there is no way to know whether the

> thicker shell will last longer than other implants and if so, whether it will

last

> one year longer or several years longer. Only when the cohesive gel implants

> are in women for 10 years or more will we know whether and how the implant

> deteriorates or changes when it is in the human body. These implants have not

> been approved by the FDA because even less is known about their safety than

is

> known about the older styles of silicone gel breast implants.

>

> Why long-term safety studies matter. In addition to silicone and saline

> implants, three other kinds of implants were developed in recent years and

used

> primarily outside the United States: Trilucent implants (with soybean oil

> filler), and Novagold and PIP hydrogel implants, which were filled with a

plastic

> gel.

>

> Although these implants were vigorously promoted by plastic surgeons and the

> media as a " natural " and safer alternative to silicone or saline implants,

> clinical trials were apparently never conducted on humans with these

implants.

> By 2000, serious safety concerns resulted in the removal of all three from

> the market._31_ (http://www.center4research.org/implantfacts.html#31) , _32_

> (http://www.center4research.org/implantfacts.html#32) , _33_

> (http://www.center4research.org/implantfacts.html#33) The fact that they had

been

> enthusiastically praised by doctors and patients when they were initially

introduced

> serves as a reminder that the long-term risks of implants are not always

> obvious during the first few years of use. That is why studies of the risks

of

> long-term use - which are still lacking for silicone implants - are essential

to

> establish the safety of all kinds of implants.

>

> Conclusion

>

> Research clearly shows that implants are associated with significant health,

> cosmetic, and economic risks within the first several years and these risks

> increase over time. Unfortunately, long-term risks remain unknown because of

> a lack of careful scientific studies. FDA has required implant manufacturers

> to conduct additional research to determine why implants break, how long they

> can be expected to last, and what the longer-term health consequences of

> broken and leaking breast implants might be. Those studies, however, have not

> yet been conducted.

>

>

> References

>

> 1 ASAPS 2005 Statistics on Cosmetic Surgery. American Society for Aesthetic

> Plastic Surgery (ASAPS), Inc., 2005. Available: _www.surgery.org_

> (http://www.surgery.org/) .

>

> 2 2005 Reconstructive Breast Surgery, American Society of Plastic Surgery

> (ASPS), Inc., 2005. Available:

>

_http://www.plasticsurgery.org/public_education/loader.cfm?url=/commonspot/secur\

ity/getfile.cfm & PageID=17845 _

>

(http://www.plasticsurgery.org/public_education/loader.cfm?url=/commonspot/secur\

ity/getfile.c

> fm & PageID=17845) .

>

> 3 ASAPS Percent of Change in Select Procedures: 1997-2004.American Society

> for Aesthetic Plastic Surgery (ASAPS), 2005. _www.surgery.org_

> (http://www.surgery.org/) . ASAPS estimates approximately 70,000 more

augmentation surgeries

> in 2004 than does ASPS.

>

> 4 ASPS 2000/2002/2003/2004 National Plastic Surgery Statistics: Cosmetic and

> Reconstructive Procedure Trends. American Society of Plastic Surgeons

> (ASPS), 2005. _www.plasticsurgery.org_ (http://www.plasticsurgery.org/) . ASPS

> reports more than 164,000 implant removal procedures among augmentation

patients

> between 2000 and 2004.

>

> 5 FDA transcript of the Advisory Panel Meeting on Mentor Saline Breast

> Implants, testimony of Dr. Sahar Dawisha, pages 431-7, 441, at

> _http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t1.rtf_

> (http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t1.rtf) ; FDA

transcript of the Advisory Panel Meeting

> on McGhan Saline Breast Implants, testimony of Dr. Sahar Dawisha, pages

> 129-148, at _http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t2.rtf_

> (http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t2.rtf) . Local

> complications are even higher, and tend to be more serious, for women with

silicone gel

> breast implants. See Inamed Corporation’s McGhan, Silicone-Filled Breast

> Implants, October 14-15, 2003, slides 39-42 and 49-51, at

> _http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt_

> (http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt)

>

> 6 FDA Summary Panel Memorandum of Inamed PMA, pages 21-22, at

> _http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed

Panel

> Memo.pdf_

>

(http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20\

Panel%20Memo.pdf) .

>

> 7 For a summary of these findings, see Zuckerman D, Santoro E, Hudak N.

> Silicone Breast Implants: Illnesses and Complications, The Latest Research

from

> Inamed's Core Study at

> _www.breastimplantinfo.org/what_know/oct03_summary.html_

(http://www.breastimplantinfo.org/what_know/oct03_summary.html) .

>

> 8 Young VL, Hertl, CH, Murray PR, et al. Microbial Growth Inside

> Saline-Filled Breast Implants. Plastic and Reconstructive Surgery. 1997; 100:

182-196.

>

> 9 Brown SL, Middleton MS, Berg WA, et al. Prevalence of Rupture of Silicone

> Gel Breast Implants Revealed on MR Imaging in a Population of Women in

> Birmingham, Alabama. Am J Roentgenol. 2000; 175: 1057-1064.

>

> 10 FDA Summary Panel Memorandum of Inamed PMA, pages 21-22, at

> _http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed

Panel

> Memo.pdf_

>

(http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20\

Panel%20Memo.pdf) .

>

> 11 Holmich L, Friis S, Fryzek J, et al. Incidence of silicone breast implant

> rupture. Arch Surg, 2003; 138: 801-6.

>

> 12 Katzin WE, Centeno JA, Feng LJ. Pathology of lymph nodes from patients

> with breast implants: A histologic and spectroscopic evaluation. Modern

> Pathology. 2002; 15: 246A. (abstract).

>

> 13 SE, Tarr G, Butterworth MS, et al. Silicone in the sputum after

> rupture of a calf implant. J R Soc Med 2001;94:133-134.

>

> 14 Bondurant S, Ernster V, Herdman, R, eds. Safety of Silicone Breast

> Implants. Washington, DC: Institute of Medicine; 1999.

>

> 15 " Silicone Breast Implants in Relation to Connective Tissue Diseases and

> Immunologic Dysfunction " Summary of Report of National Science Panel.

> _www.fjc.gov/BREIMLIT/SCIENCE/summary.htm_

> (http://www.fjc.gov/BREIMLIT/SCIENCE/summary.htm) .

>

> 16 Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between

> silicone breast implants and the risk of connective-tissue diseases. N Engl J

> Med. 2000;342:781-790.

>

> 17 Brown SL, Pennello G, Berg WA, et al. Silicone Gel Breast Implant

> Rupture, Extracapsular Silicone, and Health Status in a Population of Women.

J

> Rheumatology. 2001; 28:996-1003.

>

> 18 Aziz NM, Vasey FB, Leaverton PE, et al. Comparison of clinical status

> among women retaining or removing gel breast implants. Presented at the

American

> College of Epidemiology, 1998.

>

> 19 O’Hanlon TP. Restricted and Shared Patterns of TCR b-chain Gene

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> 24 Pukkala E, Kulmala I, Sirpa-Liis

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>

>

>

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