Breast Implant Design Innovations
One of the difficulties of studying breast implants is that the implants have changed over time. The 50+-year history of silicone breast implants is a history of trying to reduce complications, especially common problems such as implant rupture or breast hardness and pain caused by capsular contracture. Although breast implants were not studied in clinical trials for the first 30 years that they were used, companies introduced design modifications that were intended to make implants safer but were later be found to be ineffective at fixing problems and caused new ones. For example, since the mid-1960s, implant modifications have included adding a Dacron patch to fix the implant in place removing the Dacron patch changing the thick gel to a thinner gel changing the thinner gel to a thicker, more cohesive gel making the silicone shell textured, covering the shell with polyurethane foam removing the foam when it was found to break down to a carcinogen making the shell smooth changing the shape of the implants and reducing silicone bleed. Rather than being studied in clinical trials, women paid for surgery with these different types of implants. A Congressional report summarizing these changes referred to the patients as guinea pigs.8
Women Requesting Financial Help To Remove Implants
Since 2015, the National Center for Health Research has been contacted by more than 4,500 women who had breast implants that they wanted to remove because of rupture, breast pain, or medical symptoms that they believed to be related to their implants. Most of the women could not afford explant surgery, and asked for NCHRs assistance in persuading their health insurance, Medicare, or Medicaid to cover the cost of implant removal without replacement. NCHR has a project to assist these women if they have insurance but have had difficulty getting coverage for explant surgery. Most health insurance policies will cover the cost of breast implant removal when it meets the policys criteria for medical necessity. In almost all cases, medical necessity is defined as a leaking silicone gel breast implant or severe capsular contracture that causes breast hardness and pain. We are not aware of any policies that will cover removal due to systemic illnesses caused by implants, such as those described by thousands of women with breast implants. However, in many cases women have systemic illness in addition to having capsular contracture and a leaking silicone gel implant.
At the time that their implants were removed, approximately three out of five of the women had implants in their body for 10 years or more, and many had these symptoms for years. After having their implants removed, 89% of the women reported that their symptoms improved.
By Step Treatment Of Bia
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The Main Controversy: Autoimmune Connective Tissue Disease And Breast Implant Illness
The greatest controversy regarding the risks of breast implants concerns the question of whether they increase the risk of autoimmune disease and connective tissue disease. This issue has gained more recent attention now that it is clear that implants can cause ALCL, a cancer of the immune system. If implants can cause cancer of the immune system, does that mean implants can cause other immune disorders?
As noted earlier in this report, more than 50,000 women have joined two Facebook groups of women who say their breast implants cause symptoms that they refer to as breast implant illness. Doctors classify many of the symptoms they are reporting as connective tissue or autoimmune symptoms, but in many cases the women are not diagnosed with a specific autoimmune or connective tissue disorder .
Nevertheless, plastic surgeons and implant manufacturers have consistently claimed that there is no evidence that breast implants cause autoimmune or connective tissue problems. Our scientific scrutiny of the research has determined that these claims of no evidence are inaccurate. The remainder of this report will examine the evidence that is quoted by implant manufacturers and plastic surgeons, as well as the studies and results that they have often ignored.
What Are The Symptoms Of Breast Implant Illness
BIA-ALCL is often contained inside the tissue surrounding the implant. However, it can spread to other parts of your bodys lymphatic system, including the lymph nodes. The main symptoms include:
- continuous swelling or pain around your breast implant, which may occur long after a surgical incision has healed or many years after implants are inserted
- fluid collection around your breast implant
- capsular contracture, which can cause a lump under your skin or thick scar tissue around the implant resulting in a misshapen appearance
Symptoms of other breast implant complications vary. As noted above, infection is one complication associated with BIA-ALCL. Its important to treat any breast implant complications that arise. If you experience any of the following symptoms, call your doctor right away:
- dry eyes
- dry mouth
Silicone also has the potential to leak from the implant throughout the body, possibly leading to a chronic inflammatory condition.
If you experience any of the connective tissue inflammatory symptoms above, let your doctor know.
Rupture Of Implants And Its Connections With Lung Disorders
The implants, whether it is silicone or saline, normally have a safe period of 12 years after which they can rupture at any time. Many women have also reported rupture within a year or two of insertion as well due to ill handling. Saline implants are not as dangerous as silicone implants as they can be absorbed by the body in most cases. However, silicone implants have been known to cause cancer of the lungs and pulmonary fibrosis, both of which are life threatening.
Screening For Breast Implant Rupture
The FDA recommends that people with silicone breast implants receive MRI screening for silent rupture 3 years after the initial implant surgery and every 2 years after that. Getting health insurance to cover this can be challenging, so you may have to work with your doctors office on this.
If at any time you think your implant may have ruptured, have your plastic surgeon check it. An imaging test, such as an ultrasound or MRI, can help determine whether an implant is leaking. An MRI is widely considered the most accurate imaging test for this purpose. However, as with any imaging test, theres some risk that the results will not be accurate a rupture may not show up or an intact implant may appear to be ruptured on an MRI.
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Silicone Breast Implants And The Risk Of Fibromyalgia And Rheumatoid Arthritis 71
This study was described in a non-peer-reviewed abstract from a conference. It compared 533 Kansas patients with fibromyalgia and 637 with rheumatoid arthritis to 479 with osteoarthritis and 655 women randomly selected from the general population and statistically adjusted for age. Only 14 women reported having breast implants, the differences were not statistically significant, and the study lacked statistical power to draw conclusions. The information on whether the women had implants was self-reported and unverified. Patients were asked to fill out questionnaires asking if they had breast implants and the healthy controls were questioned on the telephone.
This study was not analyzed in the IOM report or Tufts report.
Fda Demands More Information On Cancer And Illnesses Caused By Breast Implants
The Food and Drug Administration decided to keep the device on the market, but wants to know more about the illnesses they may potentially be linked to.
Despite emotional testimony from women who say their breast implants made them sick with cancer or autoimmune symptoms, the Food and Drug Administration has no plans to ban the textured implants that are being blamed.
At a March 25 hearing, an FDA panel supported better product labeling and informed consent about the potential dangers of the devices, including a new, breast implant-related cancer and an autoimmune syndrome education of women who already have implants about the signs of the cancer so that they and their doctors can detect it early and an enhanced national registry of women with implants, which would allow tracking of specific device types to see if they are tied to the illnesses. A representative of the Plastic Surgery Foundation said it is working to establish such a registry.
The panel also agreed that more research needs to be regarding how breast implants can play a role in the development of cancer and autoimmune conditions. Josef Zundorf, M.D., of the German Federal Institute for Drugs and Medical Devices, testified that an international consortium will prepare research proposals on these topics to be considered in the second half of this year.
Two Kinds of Illness
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Palliative And Supportive Care
Palliative and supportive care focuses on symptom control and support. Its an extremely important part of the care and treatment for many people with secondary breast cancer and can significantly improve quality of life for them and their families.
People often associate palliative care with end-of-life treatment. However, many people value having it at any stage of their illness, alongside their medical treatment, to help prevent and relieve symptoms such as pain or fatigue. It can also help with the emotional, social and spiritual effects of secondary breast cancer.
The palliative and supportive care teams are based in hospitals, hospices and the community. You can be referred by your treatment team, GP or breast care nurse depending on your situation.
Silicone Breast Implants And The Risk Of Connective
This study included 1,183 augmentation and reconstruction patients, compared to 86,318 other women all were participants in the U.S. Nurses Health study who completed questionnaires asking whether they had breast implants and whether they had any classic connective-tissue diseases. Women with milder or atypical cases were excluded. The average length of times with implants was 10 years , and the minimum amount of time with implants was one month.
According to the authors, the study does not exclude small health risks of implants that would be of public health importance. The study was designed to minimize reporting bias of health problems by implant patients by excluding any health problems diagnosed after May 1990, which was six months before the major media coverage of implant problems. The researchers did not minimize bias in the opposite direction for example, they included women who only had implants for one month as well as women who reported having breast implants since 1952 to 1961, although breast implants had not yet been invented. For a random sample of 100 women, they verified whether the women had breast implants by looking at her medical records.
This study was not analyzed in the Tufts article.
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Join A Free Breast Implants Side Effects Lawsuit Investigation
You may qualify for this breast implant investigation under the following circumstances:
- You were implanted with textured breast implants
- You were diagnosed with Breast Implant-Associated Anaplastic Large Cell Lymphoma and/or
- Youve suffered from any illness you believe is related to the implants.
Fill out the form on this page for a free case evaluation by a breast implants injury attorney.
Silicone Breast Implants: A Rare Cause Of Pleural Effusion
Imam H. Shaik
1Department of Internal Medicine, Jersey City Medical Center, Jersey City, NJ 07302, USA
2Zaporozhye State Medical University, Zaporozhye 69035, Ukraine
3Department of Pulmonary and Critical Care Medicine, Jersey City Medical Center, Jersey City, NJ 07302, USA
4Laureate National Institute of Medicine, Program Director Internal Medicine, Jersey City Medical Center, Jersey City, NJ, USA
Pleural effusions are one of the rarest complications reported in patients with silicone gel filled breast implants. The silicone implants have potential to provoke chronic inflammation of pleura and subsequent pulmonary complications such as pleural effusion. Herein, we report a 44-year-old female who presented with left sided pleural effusion, six weeks after a silicone breast implantation surgery. The most common infectious, inflammatory, and malignant causes of pleural effusion were excluded with pleural fluid cytology and cultures. With recurrent effusion in the setting of recent surgery, the chemical reaction to silicone breast implants was sought and exploration was performed which revealed foreign body reaction to silicone material. The symptoms dramatically improved after the explantation.
2. Case Presentation
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Risks Of Silicone Breast Implants
Many people believe that silicone breast implants are only dangerous if they leak. However, these implants can present a severe health risk whether they rupture or not.
A silicone breast implant can develop a leak at any time. Since silicone is a gel-like substance, a break in the silicon pocket will not change how the implant looks or feels right awaythis is why doctors recommend regular MRIs to check for ruptures. When silicone leaks from a breast implant, it can migrate to other areas of the body and becomes impossible to remove.
At least 15% of implants are expected to rupture between 3 to 10 years after surgery.
Silicone contains carcinogens and toxins that can wreak havoc in the body. For example, it may cause connective tissue diseases, inflammation and symptoms of . Women have reported a variety of symptoms, including sinus problems, allergies and dizziness, caused by a leaking silicone implant.
Silicone breast implants still pose a risk when they do not leak. The FDA has issued a warning that can cause a rare immune system cancer called BIA-ALCL. Evidence suggests that textured implants present the highest risk of cancer.
What About Other Types Of Cancer
Although there has not been much further notable evidence linking breast implants to lung cancer, they have been linked to a rare form of lymphoma.
In 2011, the U.S. Food and Drug Administration identified the nexus between breast implants and cancer known as breast implant associated anaplastic large cell lymphoma . Since then, the FDA has continued to gather research.
More recently, regulatory action on textured breast implants in other countries has resulted in pressure on the FDA to follow suit, however the agency has held firm in its position to continue to allow breast implants on the U.S. market. The agency says it needs more information before issuing regulatory actions like recalling or restricting their sale.
We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants, the FDA said in a statement.
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Questions About The Materials In Implants
A key question that needs further investigation is whether some people may be predisposed to having a reaction to the materials in breast implants, causing inflammation and autoimmune problems. While the exact cause of BII and BIA-ALCL isnt known, some researchers have theorized that an inflammatory reaction could play a role in both conditions.
Its clear that women whove had breast implants with a textured surface have a greater risk of developing BIA-ALCL compared to women who have only ever had implants with a smooth surface. But researchers dont know why. Some have theorized that the rough surface of textured implants might cause chronic inflammation that can lead to lymphoma. Others have proposed that the rough surface and greater surface area traps more bacteria, creating a biofilm that causes inflammation and leads to lymphoma.
Some doctors consider saline-filled implants to be a safer choice for women who are concerned about the potential health risks of breast implants. If a saline-filled implant ruptures or its valve fails, its fairly easy to detect the leak because the breast will quickly appear deflated. Also, the saline that leaks out will be absorbed by the body.
However, it’s important to know that all women with breast implants are exposed to silicone to some degree, because both silicone and saline implants have a silicone shell.
Reporting Of Confirmed Cases
The U.S. Food and Drug Administration specifically recommends that all confirmed cases be reported to the PROFILE registry. The PROFILE registry is a joint effort of the FDA and ASPS/PSF. If you have been diagnosed with BIA-ALCL, please ensure your physician has reported the case to the PROFILE registry for tracking of cases. Information reported to PROFILE is updated with the FDA on a monthly basis. While PROFILE is a physician reporting system, if you would like to report your case directly, you may contact PSF who can get you in contact with a physician willing and able to report your case.
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The Health Status Of Women Following Cosmetic Surgery 60
This study included 222 Florida augmentation and reconstruction patients, compared to 80 women who underwent other cosmetic surgery. Women completed questionnaires that asked about 23 symptoms as well as the diagnosis of classic connective tissue diseases unfortunately, more than half the women contacted did not participate. The women reported having implants for an average of 4 years, with no minimum reported.
The women with implants averaged 10 years younger than the other cosmetic surgery patients. Tender and swollen glands under the arm were seven times as likely in implanted women. Symptoms that were more frequent in implanted women but did not achieve statistical significance were: easily tired, muscle pain, swollen and tender glands in the neck, change in hand color with cold, weight gain, swollen and painful joints, and general stiffness. Arthritis was present in 5% of implanted women and 3% of controls. One implanted woman reported Raynauds disease none of the women reported having scleroderma or lupus. The authors acknowledged that the small sample size could explain why the differences did not achieve statistical significance.