My personal response to the President’s State of the Union Address.... in reality, the lies the Criminal and Thief just vomited out of Trump’s mouth as the Party of Trump cheered knowing he was lying. Maybe they cheered because for the first time he was able to just read the teleprompter. Does it matter? Nope they are shameless. But I digress.
For those who don’t know me, and for those who know me and know who I am...
Know this:
I am the voice of the person or people who can or don’t want to speak out. I am the voice of the shy, afraid, or just don’t want to engage. I am the voice of frustration. I am the voice of people of all colors, all religions, all sexual orientation, all genders, all Americans and future Americans Immigrants and dreamers who love our country and respect our democracy and our constitution. Who respect the rule of law. I am the voice of the voiceless. I will never be intimidated or afraid to stand up for what’s right. I know the difference between right and wrong. I am proud to be on the right side of history. A strong women who fears No-one. And I will never, ever stay silent. If I didn’t speak out, and stayed silent, I would be compliant and complicit. And I am neither. I am also proud to know that my children and grandchildren and great-grandchildren and future generations will forever know I was and always will fight for what right and fight for truth, never accept lies.
This has never been about Republican or Democrat. This has always been about what’s right and what wrong. What is happening in our country I love, we love is just wrong. It’s that simple.
I won’t give up !! You can’t shut me up!! Ask my husband or, anyone who’s ever met me
God Bless America and God Bless all of our men and women serving in our military at home and abroad.
My personal response to the President’s State of the Union Address.... in reality, the lies the Criminal and Thief just vomited out of Trump’s mouth as the Party of Trump cheered knowing he was lying. Maybe they cheered because for the first time he was able to just read the teleprompter. Does it matter? Nope they are shameless. But I digress.
For those who don’t know me, and for those who know me and know who I am...
Know this:
I am the voice of the person or people who can or don’t want to speak out. I am the voice of the shy, afraid, or just don’t want to engage. I am the voice of frustration. I am the voice of people of all colors, all religions, all sexual orientation, all genders, all Americans and future Americans Immigrants and dreamers who love our country and respect our democracy and our constitution. Who respect the rule of law. I am the voice of the voiceless. I will never be intimidated or afraid to stand up for what’s right. I know the difference between right and wrong. I am proud to be on the right side of history. A strong women who fears No-one. And I will never, ever stay silent. If I didn’t speak out, and stayed silent, I would be compliant and complicit. And I am neither. I am also proud to know that my children and grandchildren and great-grandchildren and future generations will forever know I was and always will fight for what right and fight for truth, never accept lies.
This has never been about Republican or Democrat. This has always been about what’s right and what wrong. What is happening in our country I love, we love is just wrong. It’s that simple.
I won’t give up !! You can’t shut me up!! Ask my husband or, anyone who’s ever met me
God Bless America and God Bless all of our men and women serving in our military at home and abroad.
#womwnsvoicesmedia
Dozens of women who testified at a meeting of the agency’s General and Plastic Surgery Devices Advisory Committee last year pressed for the panel to recommend more long-term research and to support an expanded informed consent process that would give women a better understanding of the benefits and risks before they choose to have the implants. These women told compelling stories of broken health, loss of jobs and effects on families.
Many of the women called for a ban on textured implants that have been linked to the cancer anaplastic large cell lymphoma or ALCL. Health authorities around the word, as well as the FDA, link this form of cancer to some implants. Researchers said there is some evidence the problem with these implants could be bacterial infections.
Thousands of women have complained about autoimmune and connective-tissue disease caused by implants. The FDA has repeatedly said that the “weight of evidence” does not show implants cause “systemic” illness. Despite the fact that researchers at M.D. Anderson Cancer Center have found that silicone implants are linked to higher rates of autoimmune disorders such as scleroderma and rheumatoid arthritis than found in the general population, the FDA is skeptical and has said the study was flawed. In its’ announcement of the committee meeting the FDA stated “there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses”.
Diana Zuckerman, president of the National Center for Health Research, presented evidence at the hearing from a study her organization conducted involving over 400 women who had their implants removed because they were having health problems. In the vast majority of cases the women’s health improved. Zuckerman said in an interview,” We have always said we don’t know what the percentage is – just that for women who are sick, getting them out makes them better.”
The FDA has chosen not to ban the textured implants linked to the cancer anaplastic large cell lymphoma (ALCL). The agency does not believe the product meets the legal standard for being banned at this time.
“Every manufacturer of approved silicone breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their pre-market clinical trials were not designed to answer.” These are words taken from the FDA’s announcement regarding warnings issued to two manufacturers for their failure to follow these requirements. The agency has said further “poor compliance and changes in surgical practice over time have produced results difficult to interpret in a generalized manner much less with the precision needed to deliver personalized patient care.” This seems to indicate the information gathered in conducting the mandatory studies over the years has not been beneficial to patients.
On October 24, 2019, in response to the thousands of complaints, the FDA issued the Draft Guidance for Industry and Food and Drug Administration Staff. It contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. When finalized, the FDA recommends that patient labeling for breast implants include a patient information booklet/brochure, patient decision checklist, boxed warning and a patient device card.
Be aware that, even when finalized, these will only be recommendations. The document is clearly labeled as containing “nonbinding recommendations”. It does not establish any legally enforceable responsibilities. The word “should” in Agency guidance means that something is suggested or recommended, but not required. As of this writing there has been no announcement of the draft being finalized.
We end with the question with which we began.
Is the FDA still failing to warn patients of breast implant risks?
REFERENCES
MD Anderson Cancer Center https://www.mdanderson.org/newsroom/
FDA http://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
Washington Post, Laurie McGinley https://www.washingtonpost.com/people/laurie.mcginley/
Image by Anna Moneymaker/Bloomberg via Getty Images
January 22 is the 47th anniversary of the landmark Roe v. Wade Supreme Court decision legalizing abortion nationwide. Women had been dying in back-alley for decades, and Roe was thought to put an end to the fight over access to a life-saving procedure.
Far from it. The opposition forces saw the decision as a clarion call to overturn the ruling and ban abortion forever. Attacks have never stopped, and by all objective counts, abortion foes are now winning the battle.
It’s ironic that some of the worst setbacks are coming out of Texas, the state where Roe originated. In 2013 the Lone Star legislature passed laws requiring clinics to meet surgery-center standards, even if they only provide nonsurgical abortions using medication. At the same time doctors were required to obtain admitting privileges at nearby hospitals. After several years of litigation courts struck down the restrictions, but by then nearly half the state’s clinics had already closed, denying women not only abortion services but mammograms and birth control information as well.
Unfortunately Texas is not alone. Over twenty other states have enacted 70-plus different restrictions in the last few years. More restrictions have been put in place since 2011 than were adopted during the entire previous decade. And abortion isn’t the only thing in their sights. Birth control, which surely reduces the number of abortions, is also under attack with ongoing lawsuits against insurance coverage for it in Obamacare.
On the anniversary of Roe v. Wade there is always a so-called March for Life on the national mall, and both sides gather on the steps of the Supreme Court. Women’s groups will be out in force to show their support for the ruling and call attention to the erosion of reproductive rights since 1973. And a new contingent will join the usual rabid opponents and Catholic school groups this year. More than 200 members of Congress — almost all of them Republicans — urged the Supreme Court on January 2 to reconsider Roe in an amicus brief supporting a restrictive Louisiana abortion law (in some ways identical to the Texas law above) that is expected to be reviewed by the Supreme Court on March 4.
Funny, the Grand Old Party claims to have an initiative to teach candidates how to talk to women. They’re talking all right. There’s never been a better example of actions speaking louder than words.
More From Martha Burk...
There has been a lot of talk since Super Tuesday and the March 17th primaries about who turned Joe Biden’s campaign around. The consensus seems to be the African American vote did. Now that doesn’t mean all African Americans agree entirely with Biden’s views. It means African Americans are recognizing the power of their votes if they get together shoulder to shoulder.
So let’s get smart and take a note from our Black brothers and sisters. If we – women, the LGTBQ community, Native Americans, immigrants – stand together with them, we will build an alliance so strong we can gain the power politically and economically once and for all.
Of course we will continue to have our differences but we must believe no issue that separates us is more important than the common oppression we share. Then we must not buy into the hatred and divisiveness that is being fueled by Donald Trump and the Republicans.
We can be victorious and then begin the work of making America all it can be for all of us.
jj's thoughts
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