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Breast Implant Manufacturers

The FDA recognizes four companies as being manufacturers of "approved" implants

Formerly Inamed

Allergan

Allergan manufactures many products including Botox, Juvéderm, and Latisse. Their breast implant line is called Natrelle and includes both saline and gel "gummy" silicone implants. They advertise three different gummy implants with varying levels of cohesiveness designed to give varying levels of firmness. It openly discloses that the cohesiveness of the implants inside the body has not been established. The website explains how they have a "state of the art" shell on their implant designed to "help" keep the gel inside. They outline their warranty which will protect you in the case of capsular contracture or rupture to help you replace your implants. There is a small FAQ section at the bottom which states that Allergan "has been evaluating the long-term safety and effectiveness of Natrelle silicone-filled breast implants in patients since 1999." There is a quite large section at the bottom of the page outlining the conditions under which a woman is or is not eligible for breast augmentation, namely pre-existing conditions and age requirements. These include on-going infection, auto-immune disease, cancer, and depression. It outlines the fact that these are not designed to last a life time, re-operation may be necessary, the effects of the surgery are irreversible, and that ruptures are often silent and must be followed up with by periodic MRIs. In the safety information provided for the implants it is clear that great care must be taken on insertion of the implant as risk of rupture is greatly influenced by the surgeons care in placing the implant.

Website Information

Ideal Implant

Ideal Implant has an immediate tagline which states "natural feel without silent rupture" which is apparently guaranteed by containing only saline. These implants are designed by a plastic surgeon and are comprised of multiple shells with two compartments used to hold saline. This structure is apparently designed to prevent wrinkling which they attribute as a major cause of rupture. They claim that it is made of "safe" and existing materials with no silicone gel. They heavily press the safety of these implants because of their inert saline filling, no risk of silent rupture as a rupture would be apparent in the appearance of the breast, and its reinforced shell structure. They also note in fine print that the FDA has approved intact implants and recommends that any ruptured implants should be removed along with any gel. They include a YouTube video which demonstrates the danger of rupture by gel implants showing how sticky the internal substance is. This website includes rupture statistics over 10 years for each of its competitors gel implants with Natrelle implants hovering around 10-17% and Mentor at 24%. They also include another video which demonstrates the differences between saline, gel, and structured saline. The safety information states that "you likely will need additional unplanned surgery on your breasts because of complications or unacceptable cosmetic outcomes". This website actually has an extensive list of possible complications and other safety data. The complications include: Breast tissue atrophy/chest wall deformity, Calcium deposits, Lymphadenopathy, Ptosis, Toxic shock syndrome, Connective tissue disease (CTD), CTD signs and symptoms, Lymphoma, Cancer, Neurologic complications, Reproductive problems, and Suicide.

Website Information

Mentor

The mentor website is really a combination of links to separate websites detailing information about their products, procedure information, and even a refer-a-friend program. On their website detailing information about the procedure intended to help you with your decision they stat "mentor is your trusted guide to the transformation ahead of you", as if any company with a vested financial interest in your choice could possibly provide you with impartial information. They do have a link to some information about Breast Implant Associated Anaplastic Large Cell Lymphoma. They provide information about the method of implant placement such as location and incision. On their implant information site they assert that these are the only implants manufactured in the United States, that breast implants are the most studied medical device in the world and that there is a low risk of "key complications" that they do not name. There is also a clearly photoshopped photo timeline of a woman with breast implants over eight years attempting to demonstrate the implants durability over time. They repeatedly tout that the fact they are made in the USA as a reason to trust their implants. Digging a little further they present information from a final consensus report by the institute of medicine which claims that there is not substantial threat to women health posed by silicone implants. Their other safety information outlines very similar information as the others stressing care with insertion by the surgeon and to allow the patient adequate time to review the safety information before undergoing the procedure.

Website Information

Sientra

Sientra offers two main silicone implant lines a round and shaped high cohesive gel implants which they promote as being the first FDA approved implants of their kind. They claim that their implants are  the strongest on the market yet still soft and exclusively available at Sientra. They have safety information boasting only 2% rupture rate after 5 years, and 4% capsular contracture according to their studies. They offer a warranty very similar to the other manufacturers protecting against contracture and rupture to help with replacement. The provide a list of questions to ask your plastic surgeon regarding their licensure, experience, and observed complications or re-operations. They state that there is a low risk of capsular contracture, rupture, re-operation, and implant removal. There are links to more information pamphlets which provide information very much like the other manufacturers websites. Age limits, and the risks of surgery are outlined as well as a page relating how silicone is present in many products that we use every day such as baby products and makeup. Further in their educational information it does note the "not yet proven but possible" connection between implants and autoimmune diseases or connective tissue disease, cancer, or neurological problems. They state that these conditions may in the future be connected to breast implants.

 
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Breast Implant Materials

What are these things made out of anyways?

A list of some potential implant ingredients and their potential effects when encountered directly, typically in a workplace setting. Many of these are used as catalysts or components of implants and could still be present in the final product.

 

2,4-Dichlorobenzoic Acid

Causes eye irritation
Causes skin irritation, may be harmful if absorbed through the skin
May cause irritation of the digestive tract, may be harmful if swallowed
Causes respiratory tract irritation, may be harmful if inhaled

Platinum

Heavy metal

DNA alterations
Cancer
Allergic reactions
Damage to organs, such as intestines, kidneys and bone marrow

Potential to cause toxicity in other chemicals such as Selenium in the body

Trichloroethylene

Hazardous in case of skin contact, eye contact, ingestion, or inhalation
Carcinogen
Toxic to liver, kidneys, respiratory tract, nervous system, and heart
Prolonged exposure can result in organ damage

Acetone

Eye irritant causing burning, redness, watering
Central nervous system depression

Headache, dizziness, drowsiness, and nausea, unconsciousness, coma and death

Causes respiratory tract irritation. Can affect coordination and speech abilities

Methylbutynol

Eye irritation and corneal injury
Skin irritation and can be absorbed through the skin
If ingested can cause nausea, vomiting and diarrhea
Can cause blood diseases involving altered hemoglobin
Blue skin due to insufficient oxygenation
Liver Damage
Nervous system failure
Anemia and blood cell abnormalities

Toluene-2,4-diisocyanate

Carcinogen

Eye Damage

Irritation to airways and possible fluid build up in lungs

Allergies

Asthma-like symptoms

Memory and concentrations problems

Di-butyltin Dilaurate

Targets the liver, skin, brain and immune system
Skin and eye irritation
Diarrhea and abdominal pain
Hepatotoxicity and neurotoxicity
Nausea, vomiting and fatigue
Gastrointestinal hemorrhage
Renal failure and liver failure
Encephalopathy
Elevated liver enzymes
Decreased hearing, visual defects and tinnitus
Respiratory failure
Tremors and hyperexcitability
Muscle weakness and paralysis
Permanent neurologic deficits, aggressiveness,
disorientation, impaired memory and psychotic behavior
Genotoxic effects