What Women Need to Know about Silicone Gel-Filled Breast Imp

Patients may be asking about FDA's recent decision to approve the marketing of certain silicone gel-filled breast implants. They may want to know more about the safety of these devices, and they may need guidance in deciding whether or not to have them.

The approved implants are made by two companies, Allergan and Mentor. They're approved for breast reconstruction in women of all ages, and for breast augmentation in women 22 and older.

Although certain saline-filled breast implants have been available for a number of years, silicone gel-filled implants have not been available for widespread use for a long time. In fact, FDA turned down several applications to market silicone gel filled implants in the past.

However, now there is enough information about benefits and risks so that a woman can make an informed decision about whether to have the implants and what to expect if she gets them. To ensure that women get the information they need, physicians are expected to give women who are thinking about having the implants a patient brochure. The brochure lays out in some detail the benefits and complications that can occur -- complications like hardening of the tissue around the implant, breast pain, and changes in nipple sensation. One of the most important things the brochure stresses is that these implants are not lifetime devices. A woman who receives the implants will probably need additional breast surgery at least once. The brochure also informs women that the implant can rupture without causing symptoms (a "silent" rupture), and that she will need periodic MRI exams to detect these ruptures.

FDA is requiring that the companies continue to study the safety of the implants for about 10 more years after they are marketed. Each company will study about 40,000 women, and this can give more information about possible rare adverse effects.

A report by the Institute of Medicine several years ago concluded that there was no convincing scientific evidence that women with the implants are at greater risk for systemic problems like increased risk of neurological disorders, connective tissue diseases and cancer, and other studies have borne that out. But this question will continue to be addressed in the long-term studies that will be conducted by the companies.

Additional Information:

FDA Breast Implant Web Page.
http://www.fda.gov/cdrh/breastimplants/

Category:

News & Politics

Tags:

• Gel-Filled
• Silicone
• Implants
• Augmentation
• Reconstructive
• Surgery
• FDA
• Patient
• Safety
• Allergan
• Mentor

[Dragon34th]

Hi girls, Pamela Anderson here if anyone's worried & is planning to remove their ruptured implant please call me - I'm kinda broke & my rack need refilling alright. Zzzzip :) - Seriously though, so far all the blame is being put on poor manufacturing. Yes, but as a man, I think its time women with implants need proper handling training sleeping habit etc... Start educating their MEN cuz implants are like stress balls & men love handling them maybe too much. Thats why they rupture all the time.

[karezza6]

Women who put lumps of silicon inside their bodies are mentally ill.

[0duvall0]

I am very disturbed by this video. The FDA requires the Breast implant manufacture to do a 10 year study including 40,000 patients. Why are the doctors or the companies doing the study? The manufacture and plastic surgerons have a financial interest in the successful results of the study. Where is the validation of the results? I am a patient so I know there is none. My doctor dismissed my symptoms and therefore did not accurately document my case study.

[californiaspinnaker]

Corrupt Mentor keeps making implants that leak when heated in human body, FDA has been paid by Mentor Corp. to hide the facts, all implants will leak, rupture and you will need to sign form to ensure that you will not sue Mentor for Fraud !!

[californiaspinnaker]

ATTENTION !!!!!

METHYL CHLORIDE A MAJOR CHEMICAL IN SILICONE WHEN HEATED BEGIN TO DISSOLVE IMPLANT SHELL, HUMAN BODY TEMP. 98F CAUSES IMPLANTS TO RUPTURE AND FORM SCAR TISSUE THAT CAUSES INTENSE PAIN !!!

[singingmaya]

@californiaspinnaker Please come testify at the hearing in front of the FDA on Aug 30 and 31st. We need your help stop this greed ad lying luring women in thinking that there is anything safe about implants. I have very little health left and I am mad I was lied to! In 22 months my life was health, so much joint pain and they NEVER contacted me to follow up on the study. This is a massive lie.

[singingmaya]

REMOVE THEM REMOVE THEM THEY WILL RUIN YOUR LIFE!!!

[californiaspinnaker]

SILICONE IS MADE WITH METHYL CHLORIDE A VERY CANCEROUS DANGEROUS CHEMICAL !!!

My name is Bryan and I was chemist at Mentor Santa Barbara, Implants will cause lupus and Fibromyalgia and will cause joint pain !!!

DO NOT GET ANY BREAST IMPLANTS !!!!

[californiaspinnaker]

ATTENTION !!!!

My name is Bryan and I was whistleblower having worked as silicone chemist for Mentor Santa Barbara, all implants are made with Xylene which is like Benzene that cause CANCER.

When silicone is heated to 98 F in human body the silicone begin the process of weakening after first 90 days following implantation, Saline implants as water is heated also begin the process of mold formation.

Google Dr. Susan Kolb for immediate implant removal before leakage occurs !!!

ALL IMPLANTS LEAK !!