Victims Call for Informed Consent

By Catherine Ann Buckler

A major breast implant manufacturer, Allergan has paused production in Europe in response to evidence that the implants were hurting patients.

But where does the status of loosely regulated implants stand in the United States?

For victims of Breast Implant Illness, also known as BII, legal justice can only help so much. There is no getting even with the diseases, symptoms, or even cancer that can come as a result of getting implants. For most women, it is too late and the damage is done. But that does not mean they are not fighting the battle for future patients.

In the United States, most doctors and plastic surgeons have been reluctant to acknowledge Breast Implant Illness as a real condition.

Currently, most BII research and treatment is found in Europe and Canada; the U.S. is behind with implant regulations, as Europe begins to ban certain products.

Cosmetic surgeons go on to dismiss the source of their symptoms or refute the validity of illnesses of implant recipients. Currently, most BII research and treatment is found in Europe and Canada.

Under present conditions, implant victims are left to deal with post-operative disfigurement from explant surgery or mastectomies. Still other women have lost or had to leave their jobs as a result of related sicknesses, and as getting implants is considered a cosmetic procedure, most insurance companies will not cover corrective surgeries.

Gail Hamilton is the author of The D.I.R.T. Committee: Document Investigation and Review Team, a book on the Dow Corning lawsuit from the 80s.

Dow Corning is a lawsuit that is still going on; the implant manufacturer was found responsible for the women who were getting sick from their product. They filed for Chapter 11 bankruptcy “as a result of these overwhelming financial responsibilities.”

Because they filed for bankruptcy, Dow Corning got out of paying most of the women from the settlement.

Hamilton was implanted in 1975, and became sick soon after. She says she is still fighting that battle to this day.

She presented to Health Canada over the summer in June on her experience with BII and encourages victims to submit claims about the damage their implants have done to their bodies.

“My main purpose in life is to make sure women have true, informed consent when they are thinking about getting breast implants,” Hamilton says. “What they are shown at the surgeon’s office is a beautiful, clear implant. Just like a new diamond.”

Hamilton says this pristine object embodies how misleading the entire industry is: It may be flawless going in, but the deterioration that follows is under the skin and out of sight.

Hamilton is not alone. There are many victims of BII turned advocates. Nancy Gonzales Gallegos, who explanted after having her implants for 22 years, spoke in front of the FDA in March.

Through tears, Gonzales Gallegos spoke at the podium about her Allergan implants. She described how she got her implants to improve her self-esteem and pleads for “proper, informed consent.”

Nicole Daruda, of the website Healing Breast Implant Illness and private Facebook group Breast Implant Illness and Healing by Nicole has collected an arsenal of documents on the legal actions surrounding breast implants.

This past June, TV host John Oliver produced a segment on his show Last Week Tonight highlighting the questionable safety of some medical devices. Towards the end of the segment, after touching on issues with breast implants, Oliver references Daruda’s private group.

Oliver addresses that, although the website is comprehensive and an incredibly useful tool, it is unfortunate that it seems to be one of the few resources available. Ideally, patients should be able to comfortably approach their surgeons or general doctors about their concerns, and not worry about being dismissed or not taken seriously.

However, that is the common issue patients with BII face.

In the void, implant patients are forced to resort to self-diagnosing, even posting intimate breast photos online showing infections, discoloration, and deformities, while asking sympathetic strangers their opinions.

Often they conclude their posts by “outing”  doctors who discounted or misattributed their complaints to other sources. Conversely, the group also has a master list of doctors that have been helpful on their BII and explant journeys. There are even code words and phrases the group members share when appealing to insurance companies for coverage.

A complete ban of breast implants has not been voiced as feasible, or even safe. Dr. Pierre Blais says there will still be implants despite a ban, they will just be even more dangerous and less regulated, with mystery materials and in unsanitary environments.


Gail Hamilton
Gail Hamilton

Big groups like Allergen and Dow Corning rely on women not having the resources, whether financial or time-wise, to fight them. Also, many women are in the midst of suffering from BII and have trouble getting out of bed, much less than putting together a case.

The course of action that seems the most attainable for them is to inform.

“What we know is that the manufacturers are telling us anything just to sell their product,” says Hamilton. “And their prime interest is to their shareholders, and not to the end users of their product.”

Since the pain is not localized and “obviously” breast related, such as the “excruciating” pain Hamilton experienced in her hands, elbows, and feet; as well as, muscle spasms, bloody urine, and seizures, it is a hard case to win.

But Hamilton did get explanted, and like other patients suffering from BII, she is continuing to heal and pick up the pieces left behind from years of silicone poisoning and her weakened body continuously trying to fight the foreign object she had placed inside her over two decades.

Although the lawsuits are long and painful, she can take solace in her life now.

“From the time I became sick from my implants, many physical changes happened due to the poisoning and hormone fluxes in my body,” Hamilton said. “The all over body pain was unbearable. Over 20 years of fighting my way back to health, I am an old lady who missed out on my youth. But I am alive.”