US FDA Breast Implant Postapproval Studies

Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases

In the largest study of long-term safety outcomes for patients with breast implants, researchers at The University of Texas MD Anderson Cancer Center have found that silicone implants are associated with some rare diseases, autoimmune disorders and other conditions.

Abstract

Objective:
To analyze the long-term safety and efficacy outcomes of patients with breast implants.

Summary Background Data:
Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported.

Methods:
This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms.

Results:
LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations.

Conclusions:
This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.

Reference. Press release.

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.

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.

Breast-Feeding with Breast Implants : is it Safe for My Baby ?

Infant drinks milk tainted with breast implant filler

The Korean Ministry of Food and Drug Safety launched an investigation after a mother found breast implant gel in her breast milk.

“while breast-feeding my baby, I found a transparent, sticky substance mixed with the breast milk.”

the mother said.

The rupture of silicon filler is a common side effect of breast implants…

Read Infant drinks milk tainted with breast implant filler, koreatimes, 2017-01-13. Image credit c3.staticflickr.

Some breast implants can cause damage to a developing fetus

Small-sized molecules identified as endocrine disrupting chemicals can be part of some breast implants and are capable of affecting developing neurons in vitro at extremely low concentrations

breast-implants
A report published in the Journal of the Royal Society of Medicine in 2013 revealed that some breast implants do in fact pose health threats, and can cause damage to a developing fetus. Dr. Jeffrey Donaldson © image left: silicone breast implant, right: saline breast implant.

Chemical composition of some breast implants and concerns

The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks, The Royal Society of Medicine, doi: 10.1177/0141076813480994, May 2013.

… “ The significant component of breast implants is silicone (polydimethylsiloxane), not to be confused with the chemical element silicon. Although silicone does contain silicon, the former does not occur in nature and is entirely synthetic. Due to the production method, commercial silicone products will contain variable concentrations of molecular weights and sizes including a subgroup of small-sized molecules referred to as D4, D5, D6.

D4 (octamethylcyclotetrasiloxane) was identified as an endocrine disrupting chemical (EDC) of ‘high concern’ in 2007 by a report commissioned by the European Commission entitled ‘Study on enhancing the Endocrine Disrupter priority list with a focus on low-production chemicals’. The effects of low doses of such chemicals, particularly on the developing fetus, have been well documented. While most regulatory levels of impurities in breast implants are considered acceptable in the range of a few parts per million, studies have showed that EDCs are capable of affecting developing neurons in vitro at concentrations of less than one part per trillion.

In addition, the normal manufacturing process may result in traces of platinum, used as an essential catalyst. Small traces of platinum may be an acceptable find in medical grade silicone, unlike heavy metals such as tin, zinc, chromium, arsenic, lead, antimony, nickel or copper. In addition to specific health concerns associated with these heavy metals, there is also the risk that they may induce platinum toxicity. ” …

Most Women (60%) who have Mastectomy do not get Breast Reconstruction

Breast reconstruction after a mastectomy has long been an option, but a new study shows that only about 42% of women choose it

JAMA surgery background image
Access to Breast Reconstruction After Mastectomy and Patient Perspectives on Reconstruction Decision Making

Breast reconstruction after a mastectomy has long been an option, but a new study shows that only about 42 percent of women choose it.

The goal of the study was to look at how many women had the reconstruction, why some decided against it, and whether they were satisfied with their decision.

Abstract

Importance
Most women undergoing mastectomy for breast cancer do not undergo breast reconstruction.

Objective
To examine correlates of breast reconstruction after mastectomy and to determine if a significant unmet need for reconstruction exists.

Design, Setting, and Participants
We used Surveillance, Epidemiology, and End Results registries from Los Angeles, California, and Detroit, Michigan, for rapid case ascertainment to identify a sample of women aged 20 to 79 years diagnosed as having ductal carcinoma in situ or stages I to III invasive breast cancer. Black and Latina women were oversampled to ensure adequate representation of racial/ethnic minorities. Eligible participants were able to complete a survey in English or Spanish. Of 3252 women sent the initial survey a median of 9 months after diagnosis, 2290 completed it. Those who remained disease free were surveyed 4 years later to determine the frequency of immediate and delayed reconstruction and patient attitudes toward the procedure; 1536 completed the follow-up survey. The 485 who remained disease free at follow-up underwent analysis.

Exposures
Disease-free survival of breast cancer.

Main Outcomes and Measures
Breast reconstruction at any time after mastectomy and patient satisfaction with different aspects of the reconstruction decision-making process.

Results
Response rates in the initial and follow-up surveys were 73.1% and 67.7%, respectively (overall, 49.4%). Of 485 patients reporting mastectomy at the initial survey and remaining disease free, 24.8% underwent immediate and 16.8% underwent delayed reconstruction (total, 41.6%). Factors significantly associated with not undergoing reconstruction were black race (adjusted odds ratio [AOR], 2.16 [95% CI, 1.11-4.20]; P = .004), lower educational level (AOR, 4.49 [95% CI, 2.31-8.72]; P < .001), increased age (AOR in 10-year increments, 2.53 [95% CI, 1.77-3.61]; P < .001), major comorbidity (AOR, 2.27 [95% CI, 1.01-5.11]; P = .048), and chemotherapy (AOR, 1.82 [95% CI, 0.99-3.31]; P = .05). Only 13.3% of women were dissatisfied with the reconstruction decision-making process, but dissatisfaction was higher among nonwhite patients in the sample (AOR, 2.87 [95% CI, 1.27-6.51]; P = .03). The most common patient-reported reasons for not having reconstruction were the desire to avoid additional surgery (48.5%) and the belief that it was not important (33.8%), but 36.3% expressed fear of implants. Reasons for avoiding reconstruction and systems barriers to care varied by race; barriers were more common among nonwhite participants. Residual demand for reconstruction at 4 years was low, with only 30 of 263 who did not undergo reconstruction still considering the procedure.

Conclusions and Relevance
Reconstruction rates largely reflect patient demand; most patients are satisfied with the decision-making process about reconstruction. Specific approaches are needed to address lingering patient-level and system factors with a negative effect on reconstruction among minority women.

More Information:

  • Many Women Who Have Mastectomy Don’t Get Breast Reconstruction: Study, NewsHealth, August 20, 2014.
  • Access to Breast Reconstruction After Mastectomy and Patient Perspectives on Reconstruction Decision Making, JAMA Surgery, articleid=1893807, August 20, 2014.

Every Breast Implant Operation in England to be recorded on a new Register

BAAPS welcomed a clampdown on unethical advertising, as well as news from the Department of Health that an official breast implant register is to be piloted

Implant register welcomed but must be compulsory

The British Association of Aesthetic Plastic Surgeons welcomed a clampdown on unethical advertising, as well as news from the Department of Health that an official breast implant register is to be piloted. After the dissolution of the original database over seven years ago, the BAAPS has campaigned to have a compulsory system reinstated – particularly since the PIP implant crisis, which saw over 40,000 women in the UK fitted with defective medical devices.

Rajiv Grover, BAAPS President, consultant plastic surgeon, says:

Every Breast Implant Operation in England to be recorded on a new Register
Textured and silicone gel breast implants

At the BAAPS we have been very vocal in our concerns over the tone of aggressive marketing that has been allowed to proliferate unchecked over the last decade, particularly unethical deals and prizes that trivialise life-changing treatment. Whilst we’re pleased there is to be a clampdown on time-linked incentives that place undue pressure on the public, we continue to call for an outright ban on all advertising of medical procedures. People considering cosmetic surgery have a lot to think about: possible risks, their own expectations, the qualifications of the provider, recovery – whether there’s a Christmas sale, a two-for-one if they book by Friday or get Nectar points should never play a part in a sensible decision-making process.”

We are thoroughly relieved that the Government has seen the light in terms of the importance of reinstating the implant register – but the system must be made compulsory, otherwise it is a waste of time. Whilst independent consultants and many reputable groups were able to easily contact their patients during the PIP implant crisis, the scandal shone a light on shoddy recordkeeping from many corners of the sector; with women being given the wrong or no information at all in regards to what had been placed within their bodies. A centralised and comprehensive database is well overdue and essential for the public’s safety and peace of mind. We also call upon the Government to utilise proceeds from such a register for scientific research purposes, specifically into implant safety projects: it is no less than the hundreds of thousands of women undergoing breast surgery deserve.”

Based at the Royal College of Surgeons, the BAAPS is a not-for-profit organisation, established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit. The BAAPS has also long campaigned for UK-based or equivalent professional indemnity insurance to be compulsory for all surgeons practising in Britain. Members undergo thorough background screening before they can join. Information about specific procedures and surgeons’ contact details can be found on their web site, or by contacting their advice line at 020 7405 2234. Further materials can be posted to members of the public seeking specialised information. BAAPS is also on Twitter and Facebook. For all media enquiries, please email Tingy Simoes.

Sources: Sign me uplift, BAAPS Press release, 29 Dec 2013.

Related press coverage:

Breast Cancer Detection and Survival among Women with Cosmetic Breast Implants

Systematic review and meta-analysis of observational studies

Breast cancer detection and survival among women with cosmetic breast implants: systematic review and meta-analysis of observational studies
British Medical Journal aims to lead the debate on health, and to engage doctors, researchers and health professionals to improve outcomes for patients

Abstract:
Objectives:
To evaluate whether the stage distribution among women diagnosed as having breast cancer differs between those who have received breast implants for cosmetic purposes and those with no implants and to evaluate whether cosmetic breast augmentation before the detection of breast cancer is a predictor of post-diagnosis survival.

Design:
Systematic review of observational studies with two meta-analyses.

Data sources:
Systematic search of the literature published before September 2012 conducted in Medline, Embase, Global health, CINAHL, IPAB, and PsycINFO.

Study selection Eligible publications were those that included women diagnosed as having breast cancer and who had had augmentation mammaplasty for cosmetic purposes.

Results:
The overall odds ratio of the first meta-analysis based on 12 studies was 1.26 (95% confidence interval 0.99 to 1.60; P=0.058; I2=35.6%) for a non-localized stage of breast cancer at diagnosis comparing women with implants who had breast cancer and women without implants who had breast cancer. The second meta-analysis, based on five studies, evaluated the relation between cosmetic breast implantation and survival. This meta-analysis showed reduced survival after breast cancer among women who had implants compared with those who did not (overall hazard ratio for breast cancer specific mortality 1.38, 95% confidence interval 1.08 to 1.75).

Conclusions:
The research published to date suggests that cosmetic breast augmentation adversely affects the survival of women who are subsequently diagnosed as having breast cancer. These findings should be interpreted with caution, as some studies included in the meta-analysis on survival did not adjust for potential confounders. Further investigations are warranted regarding diagnosis and prognosis of breast cancer among women with breast implants.

Sources and full report: Breast cancer detection and survival among women with cosmetic breast implants: systematic review and meta-analysis of observational studies, BMJ 2013; 346:f2399

Breast Cancer reconstructive Surgery

No Easy Choices on Breast Reconstruction

No Easy Choices on Breast Reconstruction
The choices to be made in breast construction, or whether to have it at all, are highly individual

While a recent article by Angelina Jolie about her mastectomy and reconstruction raised awareness, it may have left the impression that the surgeries are quick and easy procedures, some doctors fear… For more info about:

  • Types of Reconstruction
  • Simulating a Nipple
  • Bearing the Costs
  • Uncertain Results

Read: No Easy Choices on Breast Reconstruction
by Roni Caryn Rabin, TheNewYorkTimes, 20 May 2013

PIP and Pregnancy: faulty Breast Implants could affect Foetus Development

Experts dispute conclusion of PIP breast implant scandal investigation

PIP breast implant campaigners question findings of independent report
Faulty PIP implants may pose pregnancy risk

The PIP faulty breast implants that were fraudulently filled with industrial-grade silicone may have caused their recipients harm, claim environmental scientists via the Royal Society of Medicine. The experts are particularly concerned about a chemical in the silicone filling that has been identified as an endocrine-disruptor – a substance that could potentially have an effect on the development of a foetus in the womb.

Find out more: