Proposed regulations from the federal Food and Drug Administration address problems with breast implants and call for more frequent screening, beginning at 5-6 years after surgery and every 2 years after that, for women with the devices.
Here’s a good backgrounder from the FDA on the issues:
#breastreconstruction #mammography #breastimaging #breastimplants
Following testimony by women last spring about problems caused by breast implants, the FDA will require new warning labels on the devices, and defines risks and problems with them. The public has 60 days to comment on the new regulations. Here’s how to comment and the FDA notice issued today:
The draft guidance, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling information for saline and silicone gel-filled breast implants, including:
- Boxed warning
- Patient decision checklist
- Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants
- Silicone gel-filled breast implant rupture screening recommendations
- Patient device card
When final, the recommendations in this guidance will supplement or, in some cases, replace recommendations in the FDA’s Saline, Silicone Gel, and Alternative Breast Implants guidance, issued November 17, 2006.
This draft guidance will be open for public comments for 60 days, through December 23, 2019, at www.regulations.gov under docket number FDA-2019-D-4467.
Though it’s nearly 30-years-old, far too many women do not know about a federally-funded program that pays for mammograms, Pap smears and nurse navigation help for uninsured and under-insured women. Help spread the word and post a flyer somewhere _ on electronic bulletin boards, web sites, and other places women will see it at work, school and in their communities. http://www.bcccp.org
Multidisciplinary Breast Cancer Symposium, 9/14/19; Henry
Ford Health System, Detroit
A summary of some key points, by Patricia Anstett,
- Women should request a 3-D mammogram,
also called digital breast tomosynthesis or DBT, because it’s better than
standard film-screen mammogram, particularly for women with so-called dense, or
less fatty breasts. A traditional mammogram usually takes two X-ray images of the
breast: one image from the top to bottom and another from side to side. DBT
mammography takes multiple X-ray images of the breast from multiple angles that
help a radiologist see tiny details.
- Most women can handle the information doctors
provide about a woman’s risk and treatment choices for breast cancer. Doctors
need to improve how they deliver these messages and choices.
Jennifer Plichta, Duke Health
- 90% of women with BRCA mutations are not
tested for genetic risks, and 95% of people with mutations for Lynch Syndrome,
a type of colon cancer, aren’t tested. That means too many people lose the
chance to prevent cancer or find it early.
- Medical centers are moving towards
offering earlier genetic screening before a cancer diagnosis, then offering
counseling about a woman’s risks and choices afterwards. There are many reasons
for the change, including a shortage of genetic counselors. Top genetic experts
say that identifying women as carriers of genetic mutations after they have
been diagnosed with breast cancer is a failure of cancer prevention.
- 2.1 million U.S. women have been tested
for genetic cancer risks; 13 million need testing, and another 1 million to 1.8
million need retesting because they were tested with what is not outdated techniques.
- Costs of genetic testing has plummeted
and is cheap, compared to a decade ago.
- A few medical centers have begun studies
to conduct genetic testing of children at birth for a range of diseases,
- Breast cancer is caused by a number of
gene mutations, not just BRCA1 and BRCA2. Each gene brings different cancer
risks. Information about the variance in these risks is at www.ask2me.org
- What’s coming: testing for as any as
20,000 genes, for more than cancer.
Dr. Kevin Hughes, Massachusetts General
Carcinoma in Situ
- An estimated 60,000 American women are
diagnosed each year with DCIS, an early tumor that increasingly is under debate
as to whether it should be described as cancer or a possible precursor. Its
diagnosis has increased with mammography improvements.
- Treatment decisions for women with DCIS
are among the most difficult doctors discuss with patients because it’s still
unclear which tumors may be aggressive, requiring surgery and other treatments,
and which ones can be monitored without surgery or treated with breast-conserving
options. The question is, which ones will progress and when? Studies vary from
14% to 53% in assessing which DCIS cases won’t progress.
- Most U.S. women with DCIS now get surgery
and radiation; some with estrogen-positive tumors also have chemotherapy to
reduce the risk of recurrence.
- Nearly all women diagnosed with DCIS
don’t die of breast cancer.
- Over-treating DCIS may cause physical and
mental disaffects and may affect a woman’s sexual well-being. Those issues have
raised discussion about whether some women can be followed with active
surveillance, including mammograms and MRIs.
- Factors that affect treatment decisions
for DCIS include the size of the tumor; surgical margins; pathology reports and
a patient’s age.
- New computer tools are improving a
doctor’s ability to assess and score a DCIS tumor for its likelihood to
progress. However, these tools “aren’t yet perfect” to determine who needs
surgery or radiation. Ongoing studies hope to provide better insights.
Dr. Emilia Diego, University of
Pittsburgh Medical Center
- Chemotherapy and endocrine therapy may be
offered women with more aggressive risks to down-size a tumor, allowing a woman
to have breast-sparing surgery, and possibly lower the chance her tumor will
progress. The largest study to date shows no survival advantage of these
options though they did allow seven percent of women to have a lumpectomy
instead of a mastectomy.
- So-called adjuvant therapy with the drug
tamoxifen or an aromatase inhibitor, a class of medicines that help reduce
estrogen levels in the body, has proven as effective as chemotherapy’s response
rates, while improving surgery options with fewer side effects.
- Studies undergo should help doctors sort
out whether a woman can use less toxic hormonal options with similar benefits
Dr. Haythem Ali, Henry Ford Cancer
- Medical centers are working to study
which breast cancer patients need more than a biopsy of a single sentinel node
to find whether cancer has spread. Studies show 50-70% of women have no other
tumors outside the breast other than a single node.
- Removal of more than one lymph node can
cause serious medical problems afterwards, including lymphedema, a swollen
chest and arm problem; tingling, burning of numbness in the skin; and shoulder
- New computer models are helping doctors
assess whether a woman needs more than a sentinel node biopsy if she has had
chemotherapy or endocrine therapy prior to surgery, to help reduce surgery
complications in some women.
Theresa Schwartz, St. Louis University
- There’s a new era in medicine to
de-escalate or downsize breast cancer treatment because options may cause
serious health and financial issues for patients and add significant health
- Cancer teams are using new computer tools
to calculate which tumors are most likely to cause a late recurrence of breast
cancer, which can reoccur as many as two decades later after an initial
Tatiana Prowell, Johns Hopkins Medicine
for Lymphedema Prevention
- 3-5 million breast cancer patients in the
U.S. have lymphedema, an often-debilitating swollen arm and chest condition
following breast cancer surgery, particularly after surgery to remove more than
one lymph node. Risk factors include age over 25; obesity; post-operative
radiation; and wound and drainage issues from surgery.
- Some medical teams now offer surgery that
connects lymphatic vessels in the chest and arm to veins in the arm, a type of
bypass process performed by some microvascular plastic surgeons. The technique
is challenging to perform; remains under study; and may not be a good choice
for all patients with lymphedema with various medical issues.
Dr. Dunya Atisha, Henry Ford Cancer
for Advanced Breast Cancer
- Radiation for breast cancer patients with
1-3 positive lymph nodes is under study and increasingly will benefit from
computer models sorting out which women will benefit most.
Dr. Eleanor Walker, Henry Ford Cancer
- Of the 1 in 8 women to be diagnosed in
her lifetime in the U.S. with breast cancer, 3% are between 25 and 35, prime
child-bearing ages. Half want to have children after a breast cancer diagnosis
but only 1 in 10 do.
- Chemotherapy may cause temporary or
permanent loss of ovarian function, affecting a woman’s ability to have a baby.
A woman’s age and type of chemotherapy are factors in her ability to have a
baby. Women should discuss with reproductive endocrinologists which drugs
affect their risk of having a baby later.
- Most women resume menstrual periods
within six months of chemotherapy. If a woman hasn’t started having periods 12
months after chemotherapy, it’s unlikely she will, affecting her chance to have
- Top medical centers now offer breast
cancer patients several options to preserve eggs prior to chemotherapy or surgery,
but choices vary greatly in cost and insurance coverage.
- Women can assess their chance of getting
pregnant or having a child, as well as find help with other questions, through
the Society of Assisted Reproductive Technology, www.sart.org.
- Some medical centers are willing to
perform assisted reproductive techniques within six months of a woman’s surgery
or chemotherapy, not the 24 months that remain standard in most places.
- Some studies suggest some breast cancer patients
can delay chemotherapy for two years so they can have a baby.
Dr. Monique Swain, Henry Ford Cancer
Far too many women remain unaware of all the implications of their breast cancer surgery and are unhappy with the scars they live with, a study shows. It’s very important to discuss with your breast surgeon the type of incision he/she will use in your operation.
At the request of the federal government, the manufacturer of textured breasts implants has withdrawn the product world-wide over cancer concerns. The federal Food and Drug Administration, which requested the action, said women with the implants who do not have problems do not need to remove them.
For those of you who like to find info using your phone, there’s a good new free app from a leading plastic surgeon with loads of helpful info. The link: https://www.facebook.com/BreastAdvocate/
Pending federal legislation would require health insurers to cover compression breast sleeves and other medically necessary help for breast and other surgery patients. Here’s a link with background and ways to support the bill. https://lymphedematreatmentact.org/