Can (Non-Ruptured) Breast Implants Give You Cancer ?

Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) — is a cancer that has affected a tiny proportion of the women who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer.

Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants

January 2011 Preliminary FDA Findings and Analyses

Executive Summary

Reports in the scientific community have suggested a possible association between anaplastic large cell lymphoma (ALCL) and breast implants. In this document we summarize the scientific data the FDA used to assess the possible association. It represents our current understanding, based on the published scientific literature on ALCL in women with breast implants and information gathered through the FDA’s contact with other regulatory authorities, scientific experts, and breast implant manufacturers. The document includes the FDA’s analyses of the data and steps we plan to take to better understand and characterize the possible association.

Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.

The FDA is interested in learning more about the actual incidence of ALCL in women with breast implants, the characteristics of breast implants that might increase the risk of ALCL, and the pathological characteristics and clinical features of ALCL in women with breast implants. To this end, FDA is collaborating with the American Society of Plastic Surgeons to establish a registry of cases of women with breast implants who have been diagnosed with ALCL.

Health care providers should be aware ALCL in women with breast implants is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormalities. Current recommendations are described below. As we learn more about ALCL in women with breast implants, these recommendations may change.

  • Consider the possibility of ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected ALCL, refer her to an appropriate specialist for evaluation. When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.
  • Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the reporter’s and the patient’s identity confidential.
  • Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.

Some researchers have suggested that breast implant-associated ALCL may represent a new clinically entity with less-aggressive (indolent) behavior (Li, 2010; Miranda et al, 2009; Thompson et al, 2010). Because of the small number of cases and the short median duration of follow-up, the FDA believes it is premature to draw conclusions regarding the prognosis of ALCL in women with breast implants.

Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.

More Information
  • A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’, NYtimes, MAY 14, 2017.
  • Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses, FDA, January 2011.
  • Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), FDA, Last Updated: 03/23/2017.
  • Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), FDA, Last Updated: 03/21/2017.

Can hormone replacement therapy increase the risk of hearing loss ?

The link between menopausal age, the use of oral hormonal therapy, and hearing loss

New research suggests that hormone therapy increases the risk of hearing loss among menopausal and postmenopausal women.

2017 Study Abstract

Objective

Menopause and postmenopausal hormone therapy and risk of hearing loss, menopause journal, doi: 10.1097/GME.0000000000000878, May 8, 2017.

medical news today,  articles/317387, May 10, 2017.

Image credit anthonymedicalcare.

Menopause may be a risk factor for hearing loss, and postmenopausal hormone therapy (HT) has been proposed to slow hearing decline; however, there are no large prospective studies. We prospectively examined the independent relations between menopause and postmenopausal HT and risk of self-reported hearing loss.

Methods
Prospective cohort study among 80,972 women in the Nurses’ Health Study II, baseline age 27 to 44 years, followed from 1991 to 2013. Baseline and updated information was obtained from detailed validated biennial questionnaires. Cox proportional-hazards regression models were used to examine independent associations between menopausal status and postmenopausal HT and risk of hearing loss.

Results
After 1,410,928 person-years of follow-up, 18,558 cases of hearing loss were reported. There was no significant overall association between menopausal status, natural or surgical, and risk of hearing loss. Older age at natural menopause was associated with higher risk. The multivariable-adjusted relative risk of hearing loss among women who underwent natural menopause at age 50+ years compared with those aged less than 50 years was 1.10 (95% confidence interval [CI] 1.03, 1.17). Among postmenopausal women, oral HT (estrogen therapy or estrogen plus progestogen therapy) was associated with higher risk of hearing loss, and longer duration of use was associated with higher risk (P trend < 0.001). Compared with women who never used HT, the multivariable-adjusted relative risk of hearing loss among women who used oral HT for 5 to 9.9 years was 1.15 (95% CI 1.06, 1.24) and for 10+ years was 1.21 (95% CI 1.07, 1.37).

Conclusions
Older age at menopause and longer duration of postmenopausal HT are associated with higher risk of hearing loss.

Could Birth Control Pills Make You Feel Bad ?

It’s Not in Your Head: Your Birth Control Pills Might Be Making You Feel Crappy

A new study found that oral contraceptives lowered women’s quality of life. The average decrease was small, but for certain women the effects could be significant, researchers say.

2017 Study Abstract

Objective
To determine whether there is a causal effect of oral contraceptive (OC) treatment on general well-being and depressed mood in healthy women.

Design
Double-blind, randomized, and placebo-controlled trial.

Setting
University hospital.

Patient(s)
Three hundred and forty healthy women aged 18–35 years randomized to treatment, of whom 332 completed the data collection at follow-up evaluation.

Intervention(s)
A combined OC (150 μg levonorgestrel and 30 μg ethinylestradiol) or placebo for 3 months of treatment.

Main Outcome Measure(s)
Primary outcome measures: global score of Psychological General Well-Being Index (PGWBI) and the Beck Depression Inventory (BDI); secondary outcome measures: six separate dimensions of the PGWBI.

A responsible physician should warn their patients that some women generally don’t feel well on the pill and, if this turns out to be the case, alternatives are available.

Result(s)
The OC treatment statistically significantly decreased general well-being compared with placebo −4.12 (95% CI, −7.18 to −1.06). Furthermore, OC decreased the following PGWBI dimensions compared with placebo: positive well-being −3.90 (95% CI, −7.78 to −0.01), self-control −6.63 (95% CI, −11.20 to −2.06), and vitality −6.84 (95% CI, −10.80 to −2.88). The effect of OC on depressive symptoms and on the PGWBI dimension depressed mood were not statistically significant.

Conclusion(s)
This study demonstrates a statistically significant reduction in general well-being by a first-choice OC in comparison with placebo in healthy women. We found no statistically significant effects on depressive symptoms. A reduction in general well-being should be of clinical importance.

Sources and Press Releases
  • A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial, Fertility and Sterility, dx.doi.org/10.1016/j.fertnstert.2017.02.120, April 19, 2017.
  • It’s Not in Your Head: Your Birth Control Pills Might Be Making You Feel Crappy, health, April 20, 2017.
  • The Pill image credit Sarah C.

Testing Medical Treatments : DiEthylStilbestrol

Testing Treatments Interactive, promoting better research for better healthcare

Audio published mid 2016 by Testing Treatments Interactive, promoting better research for better healthcare.

Press Play > to listen to the recording.

Sources and more information

Our SoundCloud Playlists
More DES DiEthylStilbestrol Resources

Dissenting Diagnosis

Voices of Conscience from the Medical Profession

dissenting diagnosis book cover image
Dissenting Diagnosis,
Voices of Conscience from the Medical Profession, by Dr Arun Gadre and Dr Abhay Shukla.

Complaints about the state of medical care are increasing in today s India; whether it s unnecessary investigations, botched operations or expensive, sometimes even harmful, medication. But while the unease is widespread, few outside the profession understand the extent to which the medical system is being distorted.

Dr Arun Gadre and Dr Abhay Shukla have gathered evidence from seventy-eight practising doctors, in both the private and public medical sectors, to expose the ways in which vulnerable patients are exploited by a system that promotes unscrupulous medical practices. At a time when the medical sector is growing rapidly, especially in urban areas, with the proliferation of multi-specialty hospitals and the adoption of ever-more sophisticated technologies, rational and ethical medical care is becoming increasingly rare. Honest doctors feel under siege, professional bodies meant to regulate the medical sector fail to do so, and the influence of the powerful pharmaceutical industry becomes even more pervasive.

Drawing on the frank and courageous statements of these seventy-eight doctors dismayed at the state of their profession, Dissenting Diagnosis lays bare the corruption afflicting the medical sector in India and sets out solutions for a healthier future.

  • See more DES books on this Flickr album.
  • Read How Pharmaceutical Companies Entice Doctors Into Prescribing Expensive Medication, the Caravan, 16 April 2016.
  • Read Customer Reviews on Amazon and GoodReads.

Perinatal Exposure to DES Increases the Susceptibility to Develop Mammary Gland Lesions after Estrogen Replacement Therapy

Hormones and Cancer, April 2017, Volume 8, Issue 2, pp 78–89

2017 Study Abstract

The development of the mammary gland is a hormone-regulated event.

Several factors can dysregulate its growth and make the gland more susceptible to cellular transformation.

Among these factors, perinatal exposure to xenoestrogens and hormone replacement therapy has been associated with increased risk of developing breast cancer.

Perinatal Exposure to Bisphenol A or Diethylstilbestrol Increases the Susceptibility to Develop Mammary Gland Lesions After Estrogen Replacement Therapy in Middle-Aged Rats, US National Library of Medicine National Institutes of Health, Hormones and Cancer, April 2017, Volume 8, Issue 2, pp 78–89, NCBI PubMed PMID: 28078498, 2017 Apr 8.

Here, we assessed the effects induced by estrogen replacement therapy (ERT) in ovariectomized (OVX) middle-aged rats and whether perinatal exposure to diethylstilbestrol (DES) or bisphenol A (BPA) modified these effects in the mammary gland.

Pregnant rats were orally exposed to vehicle, 5 μg DES/kg/day, or 0.5 or 50 μg BPA/kg/day from gestational day 9 until weaning. Then, 12-month-old offspring were OVX and treated with 17β-estradiol for 3 months.

Morphological changes and the percentage of epithelial cells that proliferated or expressed estrogen receptor alpha (ESR1) and progesterone receptor (PR) were analyzed in mammary gland samples of 15-month-old animals.

ERT induced lobuloalveolar hyperplasia and ductal cysts in the mammary gland of middle-aged rats, associated with a higher proliferation index of epithelial cells.

Perinatal exposure to DES followed by ERT increased the number of cysts and induced the formation of fibroadenoma and ductal carcinoma in situ, without modifying the expression of ESR1 or PR.

Also, after 3 months of ERT, BPA-exposed rats had a higher incidence of ductal hyperplasia and atypical lobular hyperplasia than animals under ERT alone.

In conclusion, perinatal exposure to xenoestrogens increases the susceptibility of the mammary gland to develop cysts and hyperplastic lesions when confronted with ERT later in life.

More DES DiEthylStilbestrol Resources

Mothers need to limit their consumption of added sugars when breastfeeding

From mother to baby: ‘Secondhand sugars’ can pass through breast milk

A new study by researchers at the Keck School of Medicine of USC indicates that a “secondhand sugar” – derived from a mom’s diet – is passed from mother to infant through breast milk.

Even a small amount of fructose – a sweetener linked to health issues ranging from obesity to diabetes – in breast milk is associated with increases in a baby’s body weight.

2017 Study Abstract

Fructose in Breast Milk Is Positively Associated with Infant Body Composition at 6 Months of Age, Nutrients, doi:10.3390/nu9020146, 16 February 2017.

From mother to baby: ‘Secondhand sugars’ can pass through breast milk, news.usc.edu, MARCH 2, 2017.

Cake credit waferboard.

Dietary sugars have been shown to promote excess adiposity among children and adults; however, no study has examined fructose in human milk and its effects on body composition during infancy.

Twenty-five mother–infant dyads attended clinical visits to the Oklahoma Health Sciences Center at 1 and 6 months of infant age. Infants were exclusively breastfed for 6 months and sugars in breast milk (i.e., fructose, glucose, lactose) were measured by Liquid chromatography-mass spectrometry (LC-MS/MS) and glucose oxidase. Infant body composition was assessed using dual-energy X-ray absorptiometry at 1 and 6 months. Multiple linear regression was used to examine associations between breast milk sugars and infant body composition at 6 months of age. Fructose, glucose, and lactose were present in breast milk and stable across visits (means = 6.7 μg/mL, 255.2 μg/mL, and 7.6 g/dL, respectively).

Despite its very low concentration, fructose was the only sugar significantly associated with infant body composition. A 1-μg/mL higher breast milk fructose was associated with a 257 g higher body weight (p = 0.02), 170 g higher lean mass (p = 0.01), 131 g higher fat mass (p = 0.05), and 5 g higher bone mineral content (p = 0.03).

Conclusion

Overall, this study suggests a novel mechanism by which infants may be inadvertently exposed to fructose through breast milk, before sugar sweetened beverages and other fructose-containing foods are introduced to the infant diet.

This work also opens the door for interventions aimed towards decreased consumption of added sugars while lactating.

Future work should be performed with larger samples with longer follow-up (>6 months) in order to establish whether the relationships observed between fructose exposure and infant growth meaningfully impact the development of obesity phenotypes in later childhood and to investigative the mechanism of such an effect at very low levels of fructose.

In conclusion, we provide preliminary evidence that fructose is present in breast milk and may be transmitted to the infant, impacting growth and body composition by 6 months of age.

Can non-daytime shifts and physically demanding jobs decrease women’s fertility?

Indeed : heavy lifting, shift work could affect women’s fertility

Women who lift heavy loads at work may experience decreased fertility, and the effect appears stronger among overweight or obese women and older women, according to a new study from Harvard T.H. Chan School of Public Health.

Working non-daytime work schedules may also decrease fertility, the researchers found. 

2017 Study Abstract

Objectives
To explore whether work schedules and physically demanding work were associated with markers of ovarian reserve and response.

Methods
This analysis included women (n=473 and n=313 for ovarian reserve and ovarian response analysis, respectively) enrolled in a prospective cohort study of couples presenting to an academic fertility centre (2004–2015). Information on occupational factors was collected on a take-home questionnaire, and reproductive outcomes were abstracted from electronic medical records. Generalised linear models and generalised linear mixed models were used to evaluate the associations.

Occupational factors and markers of ovarian reserve and response among women at a fertility centre, BMJ, dx.doi.org/10.1136/oemed-2016-103953, 6 February 2017.

Results
Women who reported lifting or moving heavy objects at work had 1.0 fewer total oocytes (p=0.08), 1.4 fewer mature oocytes (p=0.007) and 0.7 fewer antral follicles (p=0.06) compared with women who reported never lifting or moving heavy objects at work. The inverse association between heavy lifting and oocyte yield was stronger in women >37 years and with a Body Mass Index ≥25 kg/m2. Women who worked evening/night/rotating shifts had 2.3 (p<0.001) fewer mature oocytes, on average, compared with women who worked day-only shifts. None of the occupational exposures were associated with day 3 follicle-stimulating hormone or peak oestradiol levels.

Conclusions
Women working non-daytime shifts and those with physically demanding jobs had fewer mature oocytes retrieved after controlled ovarian hyperstimulation. Our results provide insight into possible mechanisms linking these occupational exposures with decreased fecundity.

Mother’s diet in pregnancy may have lasting effects for offspring

Visualizing Changes in Cdkn1c Expression Links Early-Life Adversity to Imprint Mis-regulation in Adults

A poor diet during pregnancy can cause biological changes that last throughout life, according to research from Imperial College London.

The study Visualizing Changes in Cdkn1c Expression Links Early-Life Adversity to Imprint Mis-regulation in Adults, published this week in the journal Cell Reports, showed that when pregnant mice were fed a diet deficient in protein this interfered with the expression of genes within the embryo that are known to be important for healthy growth.

The impact of adversity, such as a poor diet in early life, and whether this might cause lasting effects has long intrigued scientists. There have been suggestions that the children of women pregnant during famines, for example, may suffer harmful effects later in life. This new study offers a new way to visualise such effects and possible ways to counter these.

The researchers, at the Medical Research Council London Institute of Medical Sciences (MRC LMS), developed novel imaging techniques that enabled them to visualise genes as they were switched “on” or “off” in mouse embryos as they grew. This enabled the team to see exactly where alterations in response to maternal diet were happening and, crucially when during pregnancy key changes took place.

Understanding how genes are controlled and kept “on” or “off” is a relatively new field of science known as “epigenetics”. This is the first time such epigenetic effects have been visualised during development in this way, using a simple but powerful bioluminescent imaging approach.

The team attached enzymes from fireflies (luciferase) or bacteria (beta-galactosidase) onto the gene they were studying, and watched how this produced a glow as the gene was turned “on” in mice.

The research focused on a group of genes called “imprinted” genes, and on one in particular known as Cdkn1c. Imprinted genes are intriguing because although a copy of the gene is inherited from each parent, as usual, only one of these copies is active. The other copy is kept idle, or “silenced”. In the case of Cdkn1c, only the copy inherited from the mother is active.

Using their new visualising technique, the team showed that if a mouse carried the copy of the gene from the father, which is “silenced”, then it could not be seen. If they used either diet or drugs to re-activate it, they were able to see the gene glow. The researchers expect that this new way to “see” when imprinted genes are active or silent will prove valuable for many other scientists who are investigating epigenetic effects in our bodies.

Imprinted genes

Dr Mathew Van de Pette, a lead author based at the MRC LMS, said:

“There are around 100 imprinted genes, about 0.4% of the total in the genome, and most appear to have their greatest impact during pregnancy.
The pattern by which imprinted genes are ‘set’ in early life plays an important part in the development of healthy offspring. If a gene is ‘miss-set’ then problems may occur later.
We found that mice fed a low protein diet in pregnancy produced offspring in which the father’s copy of the gene became active and stayed that way. This demonstrates a clear link between early life adversity and later life outcomes.”

Professor Amanda Fisher, who led the study and is director of the MRC LMS, said:

“We were surprised that this change in diet permanently affected the expression of this imprinted gene.
Our work suggests there may be a window of vulnerability when diet can indeed have an effect, and that once these genes are set, they’re set for life.
The good news is that we’ve also shown that it’s possible to avoid this with a normal diet.”

Kate Wighton, Imperial College London newssummary, 03 February 2017.

Are your new generation breast implants, in fact, poisoning you?

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity

2017 Study Abstract

Background
Twenty-five years ago attorneys representing ailing women in class action litigation against silicone breast implant manufacturers made the procedural error of defining silicone-induced toxicity in the courtroom before it was properly studied in the exam room. This aberrant methodology perverted the proper research process, rendered verification of any real disease elusive, and cemented the groundwork for a repeat public health crisis potentially affecting two million women in the USA who possess new silicone gel devices inserted over the past 10 years.

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity, SAGE Publications, doi/full/10.1177/0961203317690241, January 29, 2017.

Image credit Sergio Moraes.

Patients and methods
Six women, previously well, aged 27 to 53 (mean 42), were recipients of the new generations of cohesive silicone gel-filled breast implants approved for general use by the Food and Drug Administration (FDA) since December of 2006. They averaged seven years of total implantation time, and none experienced implant rupture.

Results
All six became ill on average 3.5 years from the time of implantation. By seven years the women manifested multiple types of skin rashes, polyarthritis, fatigue, protracted AM stiffness, myalgias, headaches, photosensitivity, hair loss, paresthesias, tinnitus, lymphadenopathy, chest pain, cognitive dysfunction, dry eyes, skin pigment changes, itching, muscle twitching, dizziness, nausea, easy bruising, and odor and smell sensitivity. Three of the four who were explanted noted improvement and/or resolution of at least 50% of their total disease manifestations.

Conclusions
These six women are representative of over 70,000 other breast implant recipients who, over the past three years, have had their new silicone devices permanently removed because of alleged gel-induced toxicity. The recurrence of this public health crisis has been fueled by manufacturers’ research fraud, FDA ineptness, faulty informed consent, patient abandonment, proprietary manufacturing secrecy, misleading advertising, physician indifference, aberrant research methodology, and lax Congressional oversight.

Download the full study PDF.