Safe Medical Waste Disposal

Updated 3/2017 -- all links removed (except to my own posts) as many no longer active.

All medical offices must dispose of medical waste in a safe manner.  I closed my office at the end of September, but my last medical waste pickup is the first Friday of December.  My dear husband is going to open the office and wait for them.

How have you told patients over the years to deal with their medical waste?  Needles?  Syringes?  JP drains they pull out or that fall out before they get back for follow up? 

Last week the FDA sent out a press release announcing the launch a new website for patients and caregivers on the safe disposal of needles and other so-called “sharps” that are used at home, at work and while traveling.

…….Sharps disposal guidelines and programs vary by jurisdiction. For example, in 2008, California passed legislation banning throwing needles in household trash. Florida, New Jersey and New York have established community drop off programs at hospitals and other health care facilities. People using sharps at home or work or while traveling should check with their local trash removal services or health department to find out about disposal methods available in their area.

For the safe disposal of needles and other sharps used outside of the health care setting, the FDA recommends the following:

DO:

• Immediately place used sharps in an FDA-cleared sharps disposal container to reduce the risk of needle-sticks, cuts or punctures from loose sharps. (A list of products and companies with FDA-cleared sharps disposal containers is available on the FDA website. Although the products on the list have received FDA clearance, all products may not be currently available on the market.)    
• If an FDA-cleared container is not available, some associations and community guidelines recommend using a heavy-duty plastic household container as an alternative. The container should be leak-resistant, remain upright during use and have a tight fitting, puncture-resistant lid, such as a plastic laundry detergent container.
• Keep sharps and sharps disposal containers out of reach of children and pets.
• Call your local trash or public health department in your phone book to find out about sharps disposal programs in your area. 
• Follow your community guidelines for getting rid of your sharps disposal container.

DO NOT:

• Throw loose sharps into the trash.
• Flush sharps down the toilet.
• Put sharps in a recycling bin; they are not recyclable.
• Try to remove, bend, break or recap sharps used by another person.
• Attempt to remove a needle without a needle clipper device.

 

For more information:

• Needles and Other Sharps (Safe Disposal Outside of Health Care Settings)
• Improperly Discarded ‘Sharps’ Can Be Dangerous – Consumer Update
• Sharps Flickr Slideshow

Recent FDA Advisory Meeting on Implants

Updated 3/2017-- all links removed (except to my own posts) removed as many no longer active. 

It’s amazing what you will find sorting through more than 20 years of stuff.  This picture of 3 implants includes:  top -- an old McGhan double lumen (silicone gel implant surrounded by a saline implant); bottom left – Dow Corning textured silicone implant; and bottom right – Dow Corning smooth silicone implant.  Dow Corning has not made breast implants since approximately 1992.

Last week the FDA met to discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants.  As a condition of placing silicone implants back on the market in 2006, both Mentor and Allergan (McGhan) were suppose to enroll patients in 10-year-long follow up studies on side effects related to implants.  The aim was for 80,000 women.

I agree these studies are needed, but it is difficult to get women to return year after year.  This is evident in the data presented at the meeting:

After two years, about 60 percent of Allergan patients were still participating, but just 21 percent of Mentor patients were involved.

I, like Dr Rob Oliver (Plastic Surgery 101 Blog),  found the requirement of routine MRI screening at three years after getting implants and every two years following to look for silent ruptures to be unrealistic and unnecessary.  Insurance often did not cover this expense to the patient.  The FDA has now removed this requirement.

Several advisory panel members said the FDA's requirement that women have frequent MRIs to make sure the implants haven't ruptured is unrealistic and should be removed from the product label. Insurance usually doesn't pay for the scans, so most women don't get them done. But it's the only way to find out whether the implant has ruptured in the absence of symptoms.

The advisory panel did recommend the creation of a nationwide database to follow women who have had silicone-gel breast implants for at least a decade after they had the surgery.  I think it should be for 20 years.

Related posts:
Breast Implants -- Some History (March 3, 2008)

FDA Updates Safety Data for Silicone Breast Implants  (June 23, 2011)

REFERENCES
Breast Implant Safety to Be Focus of FDA Panel; Emily P. Walker, Washington Correspondent, MedPage Today; August 29, 2011

Breast Implant Follow-Up Far Short of FDA Goals; Emily P. Walker, Washington Correspondent, MedPage Today; August 30, 2011

FDA Panel Calls for Silicone Breast Implant Registry; Emily P. Walker, Washington Correspondent, MedPage Today; August 31, 2011

F.D.A. Affirms Safety of Breast Implants; Gardiner Harris, NY Times, August 31, 2011

FDA Updates Safety Data for Silicone Breast Implants

Updated 3/2017:  all links except to my own posts were removed as many no longer active and it was easier than checking each one.

 

Yesterday, the FDA published this press release:  FDA provides updated safety data on silicone gel-filled breast implants

In November 2006, the FDA approved silicone gel-filled breast implants for breast augmentation in women over age 22 and for breast reconstruction in all women. 

This latest report includes preliminary safety data from post-approval studies conducted by each of the two breast implant manufacturers (Allergan and Mentor), a summary and analysis of adverse events received over the years by the FDA, and a comprehensive review and analysis of recent scientific publications that discuss the safety and effectiveness of silicone gel-filled breast implants.

Based on the report, women should know:

• Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal 10 years after implantation.
• The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries) and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. Check out the FDA booklet for patients:  Breast Implants Complications Booklet.
• Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis.  However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.

At this time, the FDA is recommending that health care professionals and women who have silicone gel-filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals.  The FDA recommends women with silicone gel-filled breast implants undergo MRI screening for silent implant ruptures at 3 years post-implantation, and every 2 years thereafter.
• Be aware and pay attention to changes. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection.  Women should notify their health care professionals if they develop any unusual symptoms.
• Stay in touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

Related Posts: 
It’s Happened Again (June 5, 2007)
Breast Implants -- Some History (March 3, 2008)
Silicone vs Saline Breast Implants (March 4, 2008)
Silicone Implants and Health Issues  (March 5, 2008)
Saline or Silicone? (November 18, 2010)
More on Link Between Breast Implants and ALCL (April 25, 2011)

………………………………

Okay, now I want to rant just a bit about some of the headlines I found on this story.  All of these headlines were under the Google news/health section this morning.  I am not fond of misleading or sensationalized headlines, especially when it comes to health news.  This topic is serious to all women who have implants and they don’t deserve to be misled or inappropriately scared.

I did not read each of the following articles.  I am only commenting on my “gut” reaction to their titles.

Examples of headlines I find appalling:

Celebs who should worry about FDA's breast implant alarm (PHOTOS) (International Business Times)

Hollywood celebrities will not keep breast implants for life (Daily Gossip)
FDA: Silicone breast implants have expiration date (The Imperfect Parent) 
Bummer! FDA Says Women Can't Keep Breast Implants for Life (HyperVocal (blog))

Women who are celebrities are no different when it comes to implants than other women.  No implant has a specific expiration date.  Implants are man-made and wear out over time.  A small percentage fail in the first few years, about 20% fail by 10 years, the other 80% last more than 10 years.

The FDA did not say “women can’t keep breast implants for life.”  The FDA did make it clear that no implant currently on the market has a life expectancy equal to the normal life expectancy for a woman.

These headlines I applaud:

FDA: Silicone Implants 'Mostly Safe' and None Last Forever (33 KDAF-TV)
Silicone implants not a lifetime device (UPI.com)
Both are simple with no fear tactics included.

These headlines I find acceptable:
FDA stands by decision to put silicone breast implants back on market (Los Angeles Times)
FDA Says Silicone Breast Implants Are Safe For Women (SmartAboutHealth)
FDA Leaves Silicone Implants on Market Despite Risks (Wall Street Journal)
Breast Implants Basically Safe but Not Lifetime Devices, Say Experts (ABC News)
Breast implants reasonably safe (Washington Post)
Breast implants 'relatively safe' (BBC News)
FDA urges caution for silicone breast implant recipients (Boston Globe)
FDA Sees No New Safety Signals for Silicone Breast Implants (MedPage Today)
Most women with silicone breast implants need more surgery (msnbc.com)
Breast implants safe but not problem-free, FDA says (CBS News)
Silicone Breast Implants Deemed Safe in FDA Side Effects Review (Bloomberg)
Long-Term Complications Likely With Silicone Breast Implants (Medscape)

New FDA Sunscreen Labeling

Updated 3/2017-- all links (except to my own posts) removed as many no longer active. 

Yesterday, the U.S. Food and Drug Administration released the new rules regarding labeling of sunscreen.  The goal is to make it easier for the average person to chose a sunscreen. 

The new labels will not be in place until next summer, so you need to be aware.

When the new labels are in place, NO sunscreen will be allowed to be labeled as a SUNBLOCK or as WATERPROOF.  

Under the new labeling rules

• Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test.
• Only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.
• A warning statement will be required on any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14 stating that the product has not been shown to help prevent skin cancer or early skin aging.

In addition to the final rule for sunscreen labeling, the FDA released a Proposed Rule which would limit the maximum SPF value on sunscreen labels to “50 +”, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

Sunscreens who use the claim of being water-resistant will be required to note how long the product resists being rinsed away while swimming.  In other words, will it rinse off within 15 minutes in the water or last 2 hours.  It is important to remember, no sunscreen is “towel resistant” and can easily be removed toweling off.  It is important to reapply your sunscreen.
It is recommended that a sunscreen labeled as both broad spectrum and SPF 15 be used to protect against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation.  Both types of radiation contribute to skin cancer and premature skin aging.  Sunburns are primarily caused by UVB rays, so simply preventing of a sunburn doesn’t necessarily mean good protection from future skin cancer.

Proper Use of Sunscreen: 

• Apply the sunscreen 20-30 minutes before going outside.  Reapply every two hours when outside at a beach, etc. for adequate protection.
• Use enough. To ensure that you get the full SPF of a sunscreen, you need to apply 1 oz – about a shot glass full.
• Reapply after getting out of the water or toweling off. Even "water-proof" sunscreens are not usually "towel-proof".
• Use even on a cloudy day, up to 80% of the sun's ultraviolet rays can pass through the clouds. In addition, sand reflects 25% of the sun's rays and snow reflects 80% of the sun's rays.
• Don't forget to apply lip balm with SPF 15 or higher.

Other Sun Safe Practices:

• Staying in the shade, especially between the sun’s peak hours (10 a.m. - 4 p.m.).
• Covering up with clothing, a brimmed hat and UV-blocking sunglasses.
• Avoiding tanning and UV tanning booths.

ABC News has a nice piece:  Consumer Reports Health Rates Sunscreens

After testing 22 spray-on, cream and lotion sunscreens, Consumer Reports gave top honors to the least-expensive products.

The magazine recognized three "Best Buys" that provided excellent water-resistant protection for less than 88 cents per ounce: Up & Up Sport SPF 30 by Target; No-Ad with Aloe and Vitamin E SPF 45; and Equate Baby SPF 50.  ……..

Related blog posts:
Sun Protection (March 19, 2009)
Melanoma Review (February 25, 2008)
Melanoma Skin Screening Is Important (April 29, 2009)
Tanning Beds = High Cancer Risk (August 3, 2009)
Skin Cancer (March 24, 2010)
Safety of Sunscreens (June 14, 2010)
Dear 16-Year-Old Me (May 18, 2011)


REFERENCES
FDA Press Release; June 14, 2011;  FDA Announces Changes to Better Inform Consumers About Sunscreen
FDA:  Sunscreen

ALCL and Breast Implants

Updated 3/2017-- all links removed as many are no longer active and it was easier than checking each one.

Last week, the U.S. Food and Drug Administration requested health care professionals to report confirmed cases of anaplastic large cell lymphoma (ALCL) in women with breast implants.

The FDA made this request as they continue to investigate a possible association between breast implants, both saline and silicone gel-filled, and ALCL.

The definition given of ALCL by the National Cancer Institute calls ALCL an aggressive type of non-Hodgkin lymphoma, but oncologist Elaine Schattner, M.D. concludes after studying the FDA’s assessment (bold emphasis is mine)

Most of the ALCL tumors were limited to the area of the implant cap­sules, and could – as best I can tell from the few reports – be treated by removal of the implants and affected, adjacent breast tissue. These don’t appear to be aggressive lym­phomas, as are some ALCL’s. I would go as far as to spec­ulate that these might indeed be antigen-driven tumors; in this light, it would make sense in prin­ciple and in practice to treat these by removal of the implants, at least as a first-line approach.

 

The FDA cites the Surveillance, Epidemiology, and End Results (SEER) Program of the NCI when noting ALCL is diagnosed in the United States in  approximately 1 in 500,000 women each year. ALCL in the breast is even more rare; approximately 3 in 100 million women per year in the United States are diagnosed with ALCL in the breast (Altekruse et al., 2010).

The FDA press release mentions an awareness of about 60 cases of ALCL in women with breast implants worldwide.   The same press release later notes “a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.”

There are an estimated 5 million to 10 million women worldwide who have breast implants.

Among the 34 unique cases, the median age was 51 (28-87, with no age given in 8 cases); implant type (24 silicone, 7 saline, 3 unknown); implant texture (4 textured, 0 smooth, 30 unknown); median time from implant to diagnosis was 8 years (1-23, but not known in 11 cases); reason for implantation (11 reconstructive, 19 augmentation, 4 unknown).

The FDA notes (bold emphasis is mine):

ALCL is a very rare condition; when it occurs, it has been most often identified in patients undergoing implant revision operations for late onset, persistent seroma. Because it is so rare and most often identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, it is unlikely that increased screening of asymptomatic patients would change their clinical outcomes. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.

……..

The FDA is requesting health care professionals report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.

……..….

Women with implants should remember ALCL is extremely rare.  There is no need to change your routine medical care and follow-up.  For more information from the FDA:
Breast Implant Consumer Information
ALCL and Breast Implants Consumer Article



Other blog posts on topic:
An Oncologist Considers Rare Lymphomas in Women With Breast Implants; Medical Lessons Blog (January 28, 2011)
Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?; Science-Based Medicine Blog (January 31, 2011)

REFERENCES

FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer; January 26, 2011

Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses; FDA

Breast Implants and Lymphoma Risk: A Review of the Epidemiologic Evidence through 2008; Plastic & Reconstructive Surgery. 123(3):790-793, March 2009; Lipworth, Loren Sc.D.; Tarone, Robert E. Ph.D.; McLaughlin, Joseph K. Ph.D.

Anaplastic large-cell lymphoma in women with breast implants; JAMA. 2008;300:2030-2035; De Jong D, Vasmel WLE, de Boer JP, et al.

Asclera Now FDA Approved

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active.

The FDA recently (March 2010) approved Asclera (poliocanol) injection for the treatment of small spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter).

Asclera is a detergent sclerosant and produces endothelial damage through interference with the cell's surface lipids.and acts by damaging the cell lining of blood vessels. This causes the blood vessel to close, and it is eventually replaced by other types of tissue.

Common adverse reactions to Asclera include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site.

Although they usually occur in the legs, varicose veins also can form in other parts of the body. Factors such as genetics, age, female gender, pregnancy, obesity, and prolonged periods of standing may increase the risk for varicose veins.

Asclera is distributed by BioForm Medical Inc. of Franksville, Wis., and manufactured by Chemische Fabrik Kreussler & Co. of Wiesbaden, Germany.

Check out my old post on Spider Veins.
REFERENCES
Food and Drug Administration Newsroom
Aclera Prescribing Information (PDF)

FDA Looking at Triclosan

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

The Washington Post had a story by Lyndsey Layton this past week:  FDA says studies on triclosan, used in sanitizers and soaps, raise concerns.

The Food and Drug Administration said recent research raises "valid concerns" about the possible health effects of triclosan, an antibacterial chemical found in a growing number of liquid soaps, hand sanitizers, dishwashing liquids, shaving gels and even socks, workout clothes and toys.

The FDA and the Environmental Protection Agency say they are taking a fresh look at triclosan, which is so ubiquitous that is found in the urine of 75 percent of the population, according to the Centers for Disease Control and Prevention. The reassessment is the latest signal that the Obama administration is willing to reevaluate the possible health impacts of chemicals that have been in widespread use.

No where in the article is the use of triclosan use in suture mentioned, yet in my research on allergy/reactivity to suture material I found that it is.  From my post, Suture Allergy vs Suture Reactivity :

Allergic reactions to suture materials are rare and have been specifically associated with chromic gut. However, Johnson and Johnson mention known triclosan allergy as a contraindication for use of certain sutures (see below). Contact allergy to triclosan is uncommon…….

MONOCRYL Plus Antibacterial suture should not be used in patients with known allergic reactions to Irgacare MP(triclosan).

PDS Plus Antibacterial suture should not be used in patients with known allergic reactions to Irgacare MP (triclosan).

VICRYL*suture should not be used in patients with known allergic reactions to Irgacare MP (triclosan).  [In rechecking facts, I found that only Vicryl Plus has the triclosan, so simple vicryl or coated vicryl should be okay.]

More from the Washington Post article:

The FDA was responding to inquiries from Rep. Edward J. Markey (D-Mass.), who has been pushing federal regulators to take stronger action to restrict the use of triclosan and other chemicals that have been shown in laboratory tests to interfere with the delicate endocrine system, which regulates growth and development………

Markey wants triclosan banned from all products designed for children and any product that comes into contact with food, such as cutting boards.

Suture is not classified for use in only adults or only children.    Part of the issue with triclosan is that not enough is know about the chemical.  Do we need to not use any of the sutures with triclosan?

I am fond of PDS though I rarely use PDS Plus.  I use a lot of Vicryl, again rarely Vicryl Plus.

It seems that it is mostly the “Plus” sutures that have the triclosan, so perhaps it would be wise in children to not use those sutures until more is known.  Anyone have any thoughts on this?

Lipodissolve “Too Good to be True”

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

I have long been skeptical of Lipodissolve claims.  Patients would ask about the injections that dissolve the fat without surgery.  How it worked?  How safe is it?  Do you do it?  Do you know anyone who does?

The FDA has finally issued a warning

On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.

The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve

• are safe and effective
• have an outstanding safety record
• are superior to other fat-loss procedures, including liposuction

Notice the “unsupported claims” phrase.  I have never been able to find any good articles regarding lipodissolve so that I could intelligently answer questions regarding it. 

Lipodissolve is a procedure where the patient receives a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body.   This procedure is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

The drugs most regularly used in the lipodissolve injection procedures are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively).  Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

None of the drugs or products used have been approved by the FDA for fat dissolving or fat removal.

The FDA wants any potential lipodissolve patients to be aware:

• None of the drugs/products used in the procedure have been evaluated or approved by the FDA.
• The FDA is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination.
• The safety of the substances used in lipodissolve, when used alone or in combination, is unknown.
• The FDA is not aware of clinical studies to support medical uses of lipodissolve.

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure.  These side effects include:

• permanent scarring
• skin deformation

deep, painful knots under the skin in areas where the lipodissolve treatments were injected

I continue to tell patients that I do not advise the use of these lipodissolve procedures.   For me (and the FDA), lipodissolve is “too good to be true.”