Wednesday, March 5, 2008

Silicone Implants and Health Issues

There are many questions and concerns about silicone gel implants and the effects on the health of the woman or her child. The Supplement to the Journal of Plastic and Reconstructive Surgery covers several of these. I will try to hit the high points and conclusions. If you want more, then these articles have very nice reference lists themselves.

Silicone Implants and Connective Tissue Disease

Dr Hölmich and colleagues did a comprehensive search of PubMed, EMBASE, and The Cochrane Library. They added manual searches using the related link facility to extend the number of references identified. They identified additional references by cross-checking the reference lists of the identified publications. Here are their conclusions:

  • There appears to be little scientific basis for any association between implant rupture and well-defined connective tissue disease or undefined or atypical connective tissue diseases.
  • The concept of silicone-related disease was developed by rheumatologists based on highly selected groups of symptomatic breast implant patients seen in their practices.
  • It is likely that nonspecific complications or symptoms related perhaps to capsular contracture or implant rupture may be misinterpreted as representing a systemic disease.

Anecdotal reports and case series have suggested that silicone implants may cause various diseases, in particular, connective tissue diseases, or a new silicone adjuvant syndrome. However, large-scale epidemiologic studies have consistently failed to demonstrate increased risks of these diseases among women with breast implants.

Silicone Implants and Breast Cancer

Soon after breast implants were commercially introduced questions about potential carcinogenicity were raised. Case reports of breast cancer following augmentation mammaplasty appeared. Two early surveys intended to address the question somewhat implausibly reported zero breast cancers among 16,000 women and one breast cancer among 10,941, respectively. In addition to the question of breast cancer incidence, the possibility of delayed breast cancer detection in the augmented breast and the risk of poorer survival have raised concern.

However, over the past 20 years, a robust body of literature examining breast cancer-related risks among breast implant patients has been published. This was reviewed by Dr Deapen. Here are the conclusions:

Risk of Breast Cancer

  • The majority of studies report somewhat lower breast cancer incidence and mortality among implant patients. A comprehensive literature search and meta-analysis published in 2001 summarized results from 10 studies available at that time and estimated the relative risk for breast cancer as 0.72 (95 percent confidence interval, 0.61 to 0.85).

Delayed Detection of Breast Cancer

  • There are clear reasons for concern that implant patients may experience delayed detection of breast cancer and poorer prognosis. Nevertheless, using stage at diagnosis and tumor size as indicators of detection delay, no consistent evidence of delay or decreased survival has been found.
  • It is well-established that the silicone devices are radiopaque and obscure some portions of breast tissue from mammographic visualization, which may increase the risk of late detection. [One of the reasons for the FDA recommendation that these patients have periodic MRI's.]

Breast Cancer Length of Survival and Recurrence

  • The risk of a local and distant recurrence of breast cancer was 50 percent of expected, a non-significant difference, and the risk of secondary breast cancer was no different from expected.

Breast Cancer and Mortality

  • No difference in the breast cancer mortality experience has been found.

Silicone Implants and Breast Feeding

Despite the overwhelming advantages of breast-feeding, there is a persistent concern that maternal exposure to chemical contaminants may result in contamination of breast milk and have an effect on the child's growth and development. A parallel concern regarding lactation in women with silicone implants over the past years has led to confusion and anxiety relating to the potential risks to the child. Dr Semple reviewed the facts and issues as he knows them, including biomaterials, lactation toxicology, and a previous study where no difference was found in silicon (a proxy measurement of silicone) in women breast-feeding with silicone implants and those without. Here are his conclusions:

  • A recent study revealed that there was no significant difference in the levels of silicone in breast milk and blood between two groups of women. One group of women was breast-feeding with silicone implants, whereas the group breast-feeding without silicone implants acted as a control group.
  • Mothers with silicone implants may decide not to breast-feed because of the suspected risk of breast milk contamination. The alternative source of nutrition for these infants is a variety of commercially available formulas.
  • It is well known that there are sources of silicone in the everyday diet, including its use as an antifoaming agent in fruit juices and other types of food. Infants have been given silicone drops for colic for many years, with no identifiable problems [Mylicon drops (Merck Consumer Pharmaceutical, Ft. Washington, Pa.), used in the United States, have 67 mg of polydimethylsiloxane per milliliter and Miniform, as used in Europe, has 94 mg of polydimethylsiloxane per milliliter].

Adverse Health Outcomes in Offspring of Mothers with Silicone Implants

Dr. Kjøller and colleagues attempted to assess the question of "whether maternal cosmetic breast implants are associated with adverse health outcomes among offspring". They examined published findings of epidemiologic studies (all of Scandinavian origin) that addressed this hypothesis. Here are their conclusions:

  • Rates of esophageal and rheumatic disorders, congenital malformations, and perinatal mortality and hospitalization were comparable between children born to mothers with breast implants and children born to mothers who had undergone other cosmetic surgery.
  • Based on this review, the epidemiologic evidence to date does not support an increased risk to offspring of women with breast implants for health problems such as esophageal and rheumatic disorders, congenital malformations, or perinatal mortality.

REFERENCES

Silicone Breast Implants: Outcomes and Safety; Supplement to Plastic and Reconstructive Surgery, Vol 120, No 7, Suppl 1, December 2007

  • Breast Implant Rupture and Connective Tissue Disease: A Review of the Literature; Lisbet Rosenkrantz Hölmich, M.D.; Loren Lipworth, Sc.D.; Joseph K. McLaughlin, Ph.D.; Søren Friis, M.D
  • Breast Implants and Breast Cancer: A Review of Incidence, Detection, Mortality, and Survival; Dennis Deapen, Dr.P.H.
  • The Relationship of Silicone Breast Implants and Cancer at Other Sites; Louise A. Brinton, Ph.D.
  • Breast-Feeding and Silicone Implants; John L. Semple, M.D., M.Sc.
  • Adverse Health Outcomes in Offspring of Mothers with Cosmetic Breast Implants: A Review; Kim Kjøller, M.D.; Søren Friis, M.D.; Loren Lipworth, Sc.D.; Joseph K. McLaughlin, Ph.D.; Jørgen H. Olsen, M.D., Dm.Sc.

FDA Breast Implant Home Page

3 comments:

dancer Dallagio said...

i don't think many of these studies examined children who were breastfed by mothers with ruptured silicone breast implants who did, in fact, have high levels of silicone in both the maternal blood, offspring blood, and breast milk. it's easy to push aside the exceptions but not so easy when you have to live with them and deal with the repercussions of something you had as a child now having affected your life and that of your child for all their life.

rlbates said...

Actually, that has been looked at. There wasn't any significant differences noted between the infants/children of mothers with implants or without.

Barbara said...

Actually, there hasn't been ongoing research for children of mothers who had ruptured silicone implants when they were pregnant. My daughter who is now 22 has had joint pains, unusual skin eruptions that never heal, wry neck with stiffness, and her silicone level.30. This is abnormally high with average being.05. It is around the corner we will see many more women and children showing silicone diseases. I am sick and tired of doctors saying there is no problem with ruptured implants and pregnancy. Are you all nuts? or just blinded? This is a foreign toxic substance and is very harmful to the body. Our bodies are geared to handle this poison.Try putting your hand in sticky, gluing, silicone. It doesn't even wash off your hands because it sticks like glue. Please, for sake of health, plead for more studies, that follow through. I have had silicone in my body for 40 years. It has given my neuropathy, burning, stinging, pain. I have now had explantation and feel lucky not to have these gross bags poisoning me. Women look worse with them. They are in denial. Self narcissum thinking those big baloons are sexy. During the 20's flat was sexy...Women look like science experiments designed to sell sex.One day women will have multiple surgeries to remove the outer capsule and implants and will suffer to the pain. The costs are $15,000. Please warn women they will regret it. Show men we are good the way we are. Pamela Anderson has always looked like an artificial hard looking slut. Women be smarter than her. Don't ruin your health for trying to be the sexiest female. You can be sexy being you. Run from the Plastic surgeon. Carry yourself with confidence with your love. This is true Charisma, not those ugly big jugs staring at us.