Autologous Breast Reconstruction is a Safe Alternative After Implant Failure

Implants are usually the first choice for breast reconstruction after mastectomy. But when implant-based reconstruction fails, autologous reconstruction – using the patient’s own tissues – is a safe procedure that improves patient outcomes, reports a study in the February issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

“Autologous breast reconstruction after failed implant-based reconstruction is associated with significantly improved patient satisfaction and quality of life,” concludes the study by ASPS Member Surgeon Joseph J. Disa, MD, and colleagues of Memorial Sloan Kettering Cancer Center, New York.

Implants are the most frequent option for breast reconstruction after mastectomy, used in about 80% of patients. But in some cases, the initial reconstruction fails, due to complications or other reasons. In this situation, some patients opt for the autologous technique, with the breast reconstructed using the patient’s own tissue – typically using a flap obtained from a “donor site” in the abdomen.

Disa and colleagues analyzed 137 women who underwent autologous breast reconstruction after failed implant reconstruction. In about three-fourths of patients, the initial reconstruction failed due to scarring around the implant (capsular contracture) causing pain or deformity. Other patients had infections or other implant-related complications, or were dissatisfied with the appearance of the reconstructed breast.

The second reconstruction was performed an average of about 3.5 years after the initial procedure. Both breasts were reconstructed in 55 patients, for a total of 192 flaps. Outcomes were assessed using the validated BREAST-Q questionnaire, which evaluates various aspects of quality of life after breast reconstruction.

The results suggested that autologous reconstruction after failure of initial implant reconstruction is a safe procedure. Complication rates were similar to previous studies, despite the additional challenges posed by capsular contracture or previous radiation therapy.

Analysis of BREAST-Q responses showed “a high degree of satisfaction and quality of life” after autologous reconstruction. About one-fourth of patients filled out the BREAST-Q after both implant procedures. This group had significant improvements in satisfaction with the appearance of the breasts, psychosocial well-being, and physical well-being of the chest.

The women also reported improved satisfaction with overall well-being on the BREAST-Q. That was despite a decrease in physical well-being of the abdomen, related to the tissue donor site in the abdomen.

Implant and autologous reconstruction each have advantages for breast reconstruction after mastectomy. While reconstruction using the patient’s own tissues may provide a more natural-appearing breast, implant-based reconstruction is more widely available and less costly. Both procedures are safe and provide good reconstructive outcomes.

The new study is one of only a few to assess the outcomes of autologous reconstruction after failed implant-based reconstruction, and the first to use the validated BREAST-Q questionnaire. The results show improvements in physical and psychological well-being for this group of breast cancer survivors, as well as increased satisfaction with the appearance of the reconstructed breast or breasts.

“Regardless of reason for implant failure, this study shows changing to autologous tissue after implant removal is safe,” Disa and coauthors conclude. While there may be some additional challenges related to previous breast cancer treatment and reconstruction, they add, “The procedure has an acceptable complication rate.”

[Source(s): Wolters Kluwer Health, EurekAlert]

The Most Game-Changing Innovations in Breast Augmentation and Liposuction

All the buzz about body positivity is certainly not putting a damper on demand for major body-modification surgeries. More Americans got breast implants and liposuction in 2017 than they did the year before (300,378 and 246,354, respectively).

An entire generation that grew up hearing people talk openly about plastic surgery — rather than seeing it as taboo — now has disposable income. And the more interest there is in these procedures, the more incentive there is to perfect them. These are the most game-changing innovations in breast augmentation and liposuction — straight from the surgeons who are scrubbed up at the front lines.

Allergan plc Suspends European Sales of Implants and Expanders Following Recall

Allergan plc, headquartered in Dublin, Ireland, has suspended sales of textured breast implants and tissue expanders and is withdrawing any remaining supply in European market, the company announces.

The withdrawal decision follows a compulsory recall request from Agence Nationale de Securite du Medicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company’s CE Mark for these products.

Although Allergan disagrees with ANSM’s request, the company is fully cooperating with the authority. Allergan stands behind the benefit/risk profile of its breast implant products.

The ANSM request, and this action, is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants, Allergan states in a media release.

“Breast implants play a vital role for patients’ physical and psychological health. For many patients, textured breast implants provide a critical option for surgeons to provide the right solution for each individual need,” says Michael Atlan, associate professor, Pierre et Marie Curie Faculty of Medicine, and a plastic surgeon at Tenon Hospital (Assistance Publique-Hopitaux de Paris), in the release.

“Importantly, the safety profile of textured breast implants is known and surgical removal is not being recommended on this information alone, particularly given the known risks removal can have for patients.”

The company looks forward to participating in the scientific forum that ANSM has scheduled for early February where the full set of data and scientific evidence for textured breast implants can be presented and thoroughly discussed by all stakeholders.

“Patient safety and product quality are Allergan’s highest priorities. Allergan takes this situation very seriously and is committed to engaging with all stakeholders to ensure they have the most up-to-date information,” states Charles Hugh-Jones, chief medical officer at Allergan.

“We are committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence, and to the highest industry standards for our products.”

Allergan will continue to work through the CE Mark renewal with GMED, and is planning an appeal to ensure that appropriate patients have access to the products that their surgeons recommend.

Importantly, the CE Mark for Allergan’s smooth implants has been renewed by GMED. Smooth implants are not affected and continue to be available for patients. It is also important to note that the United States does not require the CE Mark, so it is unaffected by the action, the release concludes.

[Source(s): Allergan plc, PR Newswire]

Penn Medicine Surgeons Perform World’s First Robotic Bilateral Breast Reconstruction

A team of surgeons from the Perelman School of Medicine at the University of Pennsylvania are the first in the world to use a surgical robot to assist with a bilateral free flap breast reconstruction – a procedure in which tissue is taken from the lower abdomen – similar to a “tummy tuck” – and used to rebuild the breast.

The robot allows surgeons to make a much smaller incision into the abdominal wall muscles, allowing patients to recover and be discharged more quickly and without the use of addictive narcotic painkillers.

Suhail Kanchwala, MD, an associate professor of Plastic Surgery, led the team that performed the procedure, which took place at Pennsylvania Hospital earlier this month. Kanchwala partnered with Ian Soriano, MD, FACS, a clinical assistant professor of Surgery, who specializes in minimally invasive procedures, to develop the technique.

For more information, read the full press release at www.pennmedicine.org

Age Alone Doesn’t Increase Complications of Free-Flap Breast Reconstruction in Older Women

Breast reconstruction using a “free flap” from the patient’s abdomen is a safe procedure with a high success rate in older women opting for reconstruction after mastectomy, reports a study in the December issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Although the risk of some complications is higher, free-flap reconstruction has “generally good outcomes” in women aged 65 or older, according to the report by ASPS Member Surgeon Oren Tessler, MD, MBA, and colleagues of Louisiana State University Health Sciences Center, New Orleans.

“Older women desire breast reconstruction after mastectomy, and should be offered all reconstruction options available,” Tessler comments, in a media release from ASPS.

To read the full press release about the study, visit www.eurekalert.org

Doctors, Patients Raise Alarms About Cancer Linked to Breast Implants

Women choose to get breast implants either for breast reconstruction after mastectomy or for cosmetic reasons. The American Society of Plastic Surgeons reported 400,000 breast implant procedures took place in 2017, up nearly 40 percent since 2000.

It’s taken several years to gather data but the FDA now believes that textured breast implants may be more likely to cause ALCL, although it says smooth implants are also linked to an increased risk. The trouble is that there’s no organized effort to put together data from people who have implants and those who have developed ALCL.

TIGR Matrix Offers Improved Reconstruction Outcomes, Study Suggests

Use of the synthetic and fully resorbable TIGR Matrix surgical mesh helped improve the outcome in breast cancer patients undergoing immediate reconstruction, according to a study published in the Journal of Plastic Surgery and Hand Surgery.

The TIGR Matrix and other surgical meshes aim to support, and hold in place, breast implants to improve the aesthetic result with decreased risk of capsule formation. However, traditional meshes, such as the biological acellular dermal matrices, have been linked to severe complications including seroma, necrosis, and the loss of implants.

In the study, lead author Hakan Hallberg and colleagues investigated the use of the TIGR Matrix in a prospective series of 49 consecutive patients undergoing immediate breast reconstruction with a tissue expander or permanent implant. All patients were non-obese, current non-smoker, and not scheduled for postoperative radiotherapy, explains a media release from Novus Scientific.

The TIGR Matrix—produced by Novus Scientific AB, headquartered in Uppsala, Sweden—resulted in a low incidence of complications. The rate of implant-loss was similar as reported with other matrices. Furthermore, TIGR Matrix showed a 3.1% incidence rate of seroma and a 1.5% risk of infections. For comparison, the reported incidences of seroma and infection with other matrices are up to 15% and 30%, respectively.

Immediate breast reconstruction with a tissue expander and TIGR Matrix surgical mesh has a low complication rate, concluded the investigators of the Sahlgrenska University Hospital in Gothenburg, Sweden, per the release.

[Source(s): Novus Scientific, PR Newswire]

New Method of Breast Reconstruction May Reduce Pain for Some Cancer Survivors

Hani Sbitany, MD, is one of a handful of surgeons who are pioneering and studying the outcomes of a new approach that is less invasive, has a less painful recovery, and results in more natural-looking breasts.

The procedure is called a prepectoral reconstruction, and involves placing the implants on top of the pectoralis muscle, just under the skin where breast tissue naturally resides.

“Whether it’s loss of strength, whether its chronic pain or whether animation deformity – there are drawbacks to putting these implants under the muscle,” says Hani Sbitany, MD, a plastic and reconstructive surgeon at UCSF Health.

Read the full article at medicalxpress.com.

PREVENA System Could Help Reduce Complications, Studies Suggest

KCI announces that recently published data stemming from two studies demonstrate that closed incision negative pressure therapy (ciNPT) with the PREVENA Incision Management System reduced postsurgical wound complication potential in patients recovering from oncological breast surgery and breast reconstruction, respectively.

One study titled, “The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes,” showed that patients who received ciNPT with the PREVENA System had significantly lower rates of overall complications and returns to the operating room compared to those in the standard of care (SOC) for incision management after breast reconstruction post-mastectomy group. In addition, patients in the PREVENA Therapy group overall had a shorter mean time to complete removal of all drains than the SOC group, averaging 9.9 days versus 13.1, respectively.

In a separate study titled, “Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings,” researchers found that patients in the PREVENA Therapy group showed significantly lower postsurgical complication rates, demonstrating 4 percent in the PREVENA Therapy group versus 45 percent in the SOC group.

“Minimizing the risk of complications for the patients in my care is of the utmost importance to me as a practicing plastic surgeon, and this recent data adds to the established body of evidence that demonstrates the ability of PREVENA Therapy to help preserve outcomes for breast reconstruction patients,” said Ron Silverman, MD, FACS, Chief Medical Officer, KCI, an Acelity Company. “Further, this data has implications for lowering healthcare costs and improving quality and the patient experience as post-operative complications create a tremendous burden impacting patients, surgeons and payers. At KCI, we are dedicated to bringing to market innovations that address these needs supported by proven-real world results that improve patients’ lives.”

Study Overviews

“The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes”:

  • A single site, retrospective review of records for 356 adult female patients who underwent breast reconstruction post-mastectomy was conducted. Records were divided into two groups for comparative analysis: patients who received SOC versus patients who received ciNPT with the PREVENA Incision Management System for closed incision management post breast reconstruction.

“Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings”:

  • In a study of 37 patients undergoing oncological breast surgery, 17 patients (25 surgeries) received ciNPT with the PREVENA Incision Management System and the remaining 20 patients (20 surgeries) had SOC.

Both studies were published in Plastic and Reconstructive Surgery – Global Open.

[Source(s): Acelity, Business Wire]

Life After Breast Cancer: When Is it Time for a New Implant?

If you choose breast implants for reconstruction, it’s important to know that they don’t always last forever. The time may come when you need to consider replacement or maintenance of your implants.

While implant reconstruction offers a safe, straightforward and effective way to restore breast contour after mastectomy, it’s possible to have trouble with your implants years later.